10 AstraZeneca openings at Shanghai, Chinese only

Please send cv to hms_jobhunting@hotmail.com if interested.

All jobs are located at AstraZeneca Shanghai

1. Clinical Operations Enablement Associate

Description:

Actively supports Clinical Operations by ensuring the population and availability of complete, high quality data from Clinical Operations processes and systems. Delivers Clinical Operations processes and systems training and participates in the coordination of the life cycle management of processes and systems/tools including associated documentation (procedural, system). Delivers global central services across drug projects and/or other activities that enable delivery of Clinical Development programs to time, cost, and quality across all delivery models.  The role requires the demonstration of professionalism and mutual respect in all interactions.

Accountabilities/Responsibilities:

·         Set-up and maintains systems/tools and data associated with  Clinical Operations enabling services in partnership with Study Teams to appropriate standards, completeness, quality and consistency 

·         Participates in the life cycle management (development, implementation, compliance, maintenance, issue resolution, continuous improvement, decommissioning) of Clinical Operations processes, systems/tools, standards, procedural documentation and training materials  

·         Delivers shared services across drug projects (e.g. document management support, Investigator Safety Letter Distribution, system support)

·         Supports activities that ensure Clinical Operations compliance and license to operate (e.g. HCP regulations); Supports activities associated with audits, regulatory inspections and litigation requests in conjunction with study delivery teams, CA&A and other stakeholders

·         Provides appropriate support and expertise (process and systems/tools) to user communities including Alliance Partners and/or AZ Interface roles; Receives and loads data from external partners for internal processing; Ensures the monitoring of the integrity of data in systems and learning applied in process improvements

·         Supports the development of business cases for prioritization of Continuous Improvement  project proposals

·         Conducts relevant process and system/tool trainings; Works with teams and colleagues across the organization to support consistent ways of working and adherence to best practice; Develops and maintains communication tools supporting Clinical Operations

·         Contributes to the development of User Requirement Specifications 

Minimum Requirements – Education and Experience

·         University degree or equivalent work experience

·         Experience in the pharmaceutical industry working in an environment of clinical study delivery/clinical development processes

·         Knowledge of pharmaceutical drug development and clinical study processes and associated government regulations, ICH and GCP

Preferred Requirements – Education and Experience

·         University degree in biological science or health care related field

·         A good understanding of the clinical study process

·         Programming experience or programming aptitude

Skills and Capabilities

·         Good organizational and project management skills; Proactively identifies risks and issues and possible solutions; Demonstrates ability to follow tasks through to completion

·         Ability to understand how task combine into efficient workflow

·         Demonstrates computer proficiency, the ability to develop advanced computer skills, and the technical aptitude  to increase efficiency in day-to-day tasks 

·         Technical skills or knowledge expertise in one or more areas supported (e.g. Study Management, Data Management, IVRS, Data standards, etc.)

·         Holds self accountable for achieving objectives, applying best practice, and adhering to standards 

·         Proven analytical thinking, concern for standards, and willingness to learn from others

·         Ability to work collaboratively in a team environment as well as independently

·         Demonstrates professionalism and mutual respect

·         Good negotiation and conflict resolution skills

·         Good written and verbal communication skills in English

Leadership Skills:

·         Passion for Customer (Target Level 2)

·         Thinks Strategically (Target Level 2)

·         Acts Decisively (Target Level 2)

·         Drives Performance (Target Level 2)

·         Works Collaboratively (Target Level 2)

Internal and External Contacts/Customers (Examples)

·         Study Management, Study Team personnel

·         Marketing Company personnel

·         Study Site personnel

·         Monitoring personnel

·         Other Clinical Operations/Clinical Development personnel as appropriate

·         External Service Provider personnel



2. Clinical Operations Enablement Leader

Description:

Leads, develops and delivers in areas of central services, knowledge management, compliance improvement activities, and other activities that enable delivery of Clinical Development programs to time, cost, and quality across all delivery models.  Partners with Business Areas in support of life cycle management and continuous improvement of Clinical Operations process, tools, and standards and works with key stakeholders (e.g. CA&A, CE&L) to assimilate new practices and training into Clinical Operations and ensure consistency within and across hubs. The position requires effective and efficient delivery while maintaining effective and positive organizational relationships.  The position requires working collaboratively with persons of influence and decision-making authority within Clinical Operations as well as other global/regional functions and the use of considerable tact, discretion and persuasion to develop and drive a culture of continuous improvement and adherence to consistent work practices.    

Accountabilities/Responsibilities:

·    Works closely with Business Area Owners, Study Standards, Processes and Tool Leaders,CISGO, delivery partners and business support networks across Clinical Development to provide input and expertise to systems, processes, and standards development, business continuity plans, prioritization of tool enhancements, and implements resolution of process and tool related issues

·    Develops and implements business continuity and life cycle management (development, implementation, compliance, maintenance, issue resolution, continuous improvement, decommissioning) for Clinical Operations processes and tools and supports consistency within and across the hubs/regions in partnership with key stakeholders across Clinical Development

·         Acts as Study Standards, Process and Tool Leader as needed

·         Leads the operational delivery of central services and partners with key stakeholders to assimilate new practices and training into Clinical Operations.  Liaise globally with project and function to ensure delivery of consistent, effective and efficient services.

·         Develops and Leads Clinical Operations knowledge management and communication activities that drive dynamic sharing of knowledge/ information to ensure consistent adoption of new practices within Clinical Operations and across Clinical Development

·         Develops business cases and leads/participates in continuous improvement initiatives according to the Improvement Project Operating Model (IPOM)

·         Leads and/or contributes to activities that ensure Clinical Operations compliance and license to operate (e.g. HCP regulations); Leads and/or contributes to activities in support of audits, regulatory inspections and litigation requests in conjunction with study delivery teams, CA&A and other stakeholders; Leads and/or coordinates activities in support of any local or national legislation reporting requirements

·         Leads and contributes to the development, enhancement and implementation/training of global/local processes, procedural information and other competency programs to embed understanding and to ensure compliance. Coordinate compliance improvement activities.

Minimum Requirements – Education and Experience

·         Bachelors of Science degree in related discipline, preferably in medical or biological science, or equivalent work experience in directly related fields of endeavors

·         Minimum 7 to10 years in the pharmaceutical industry working in an environment of clinical study delivery/clinical development processes

·         Experience with process design and implementation 

·         Proven leadership experiences (people and project) including team facilitation

·         Experience working internationally

·         Ability to travel both domestic and international

Skills and Capabilities

·         Ability to effectively lead complex continuous improvement projects in a global environment according to the Improvement Project Operating Model (IPOM)

·         Proven Project management skills (including scope, budget, timeline, and resource management and use of associated tools); Demonstrates the ability to set and manage priorities, performance targets and risk; Demonstrates effective meeting planning, coordination and facilitation skills 

·         Technical skills or knowledge expertise in one or more areas supported (e.g. Study Management, Data Management, IVRS, and Data Standards etc.)

·         Ability to identify areas needing improvement, applying external awareness and methodologies (e.g. Lean Sigma) that develop more effective and efficient ways of working, and planning and executing the implementation of the solution 

·         Proven Conceptual, Analytical and Strategic thinking; concern for standards and willingness to learn from others

·         Proven excellent negotiation, interpersonal, problem solving and conflict resolution skills

·         Positive change management skills and champion of continuous improvement

·         Works collaboratively and motivates and empowers others to accomplish individual, team and organizational objectives

·         Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement

·         Demonstrated aptitude for process and technology

·         Comprehensive knowledge of GCP, AZ Procedural documents, as they pertain to Clinical Operations systems, processes, and services

·         Excellent written and verbal communication skills in English

Leadership Capabilities

·         Passion for Customer (Level 2 or higher)

·         Thinks Strategically (Level 2 or higher)

·         Acts Decisively (Level 2 or higher)

·         Drives Performance (Level 2 or higher)

·         Works Collaboratively (Level 2 or higher)

Preferred Background

·         Advanced degree in biological sciences, healthcare related field or business

·         Clinical operational experience 

·         Experience in cross-functional pharmaceutical development

·         Demonstrated leadership in delivery of centrally managed services

·         Programming experience or programming aptitude

Internal and External Contacts/Customers

·         Colleagues across multiple departments within AstraZeneca, both globally and regionally

·         External consultants and service providers

3. Clinical Operations Enablement Specialist

Description:

Coordinates the life cycle management and business continuity of Clinical Operations processes and tools, performs critical analysis to identify improvements, and develops reports and reporting tools for Clinical Operations systems.  Coordinates and delivers central services across drug projects and/or other activities that enable delivery of Clinical Development programs to time, cost, and quality across all delivery models. The position requires the ability to negotiate and influence leaders and decision-makers across various departments within AstraZeneca both globally and regionally.   

Accountabilities/Responsibilities:

·         Coordinates and delivers central services across drug projects (e.g. document management support, DMPL support, IVRS delivery, clinical trial disclosure, system support, data handling/loading from external partners)

·         Coordinates life cycle management (development, implementation, compliance, maintenance, issue resolution, continuous improvement, decommissioning) and business continuity for Clinical Operations processes, systems/tools, standards, procedural documentation and training materials; supports consistent ways of working and adherence to best practice; Acts as Study Standards, Processes and Tool Leader as needed

·         Provides expert support (process, systems/tools, standards) to user communities including CISGO,  Alliance Partners and AZ Interface roles

·         Coordinates and participates in activities that ensure Clinical Operations compliance and license to operate (e.g. HCP regulations); Supports activities associated with audits, regulatory inspections and litigation requests in conjunction with study delivery teams, CA&A and other stakeholders

·         Conducts relevant process and system/tool trainings; Facilitates dynamic sharing of knowledge and establishment of best practice; Ensures and develops effective and consistent communication within Clinical Operations

·         Conducts critical analyses of Clinical Operations processes and tools to define business usage and identify opportunities to improve efficiency/effectiveness of systems/methods/process; Defines and develops User Requirement Specifications

·         Maintains an awareness of the trends/changes in the external clinical process and technology environment to identify opportunities for improvement; participates in the evaluation and assessment of new technologies

·         Defines and develops User Requirement Specifications

·         Contributes input and/or develops business cases for Continuous Improvement project proposals

·         Participates in change initiatives relating to Clinical Operations

Minimum Requirements –Education and Experience

·         University degree in biological science, health related field, licensed registered nurse or equivalent experience

·         Four or more years in the pharmaceutical industry working in an environment of clinical study delivery/clinical development processes

·         Working knowledge of pharmaceutical drug development and clinical study processes and associated government regulations, ICH and GCP

Preferred Requirements – Education and Experience

·         University degree in biological science or health care related field

·         Clinical operational experience

·         Programming experience or programming aptitude

Skills and Capabilities

·         Demonstrates operational expertise in project management, risk management and contingency planning; ability to set and manage priorities, resources, goals and project initiatives; demonstrates effective meeting planning, coordination and facilitation skills

·         Demonstrated aptitude for process and technology

·         Technical skills or knowledge expertise in one or more areas supported (e.g. Study Management, Data Management, IVRS, Data standards, etc.)

·         Develops and applies understanding of life cycle management and Business Continuity Planning; ability to understand the impact of technology on projects and processes; understand how tasks combine into efficient workflow 

·         Has in depth knowledge of GCP, AZ Procedural documents, as they pertain to Clinical Operations systems and processes

·         Holds self accountable for achieving objectives, applying best practice and adhering to standards

·         Proven Conceptual and Analytical thinking; concern for standards and willingness to learn from others

·         Positive change management skills and champion of continuous improvement

·         Demonstrates professionalism, diplomacy and the ability to manage/value diversity and cultural differences and promote productivity through encouragement

·         Demonstrated ability to work collaboratively in a team environment as well as independently; proven ability to facilitate team building/team work; share ownership and visibility

·         Excellent negotiation and conflict resolution skills

·         Excellent written and verbal communication skills in English

·         Ability to travel both domestic and international

Leadership Capabilities:

·         Passion for Customer (Target Level 2)

·         Thinks Strategically (Target Level 2)

·         Acts Decisively (Target Level 2)

·         Drives Performance (Target Level 2)

·         Works Collaboratively (Target Level 2)

Internal and External Contacts/Customers (Examples)

·         Study Management, Study Team personnel

·         Marketing Company personnel

·         Study Site personnel

·         Monitoring personnel

·         Other Clinical Operations/Clinical Development personnel as appropriate

·         External Service Provider personnel

4.

Compliance Advice & Assurance Lead Advisor

Description:

The CA&A Lead Advisor is a senior compliance professional operating in a global cross functional environment providing compliance advice to global teams, developing global audit programs and executing routine and complex global audits, independently with minimal supervision. The Lead Advisor assures that appropriate risk assessment, advice and initial assessment of new and relevant regulation that impacts on Clinical Development are appropriately encompassed in AstraZeneca functional and quality assurance procedures.

The Lead Advisor focuses on technical issues as a primary source of regulatory interpretation and provides solid tactical insight into regulatory compliance strategies and uses risk management to evaluate compliance issues and develop solutions. The Lead Advisor ensures that AstraZeneca clinical programmes and relevant product support activities and the processes that support them are delivered to appropriate standards that will assure product and data integrity and acceptability.

Accountabilities/Responsibilities:

·           Provides compliance advice, develops audit programs and conducts audits (studies,     projects, systems and specific compliance areas), communicates audit findings and improvement recommendations  both within AZ and externally including vendors and other providers of clinical services in line with the global Q&CD strategic direction and individual compliance area/region strategic decisions

·           Provides lead point of interface for delivery of CA&A activities for assigned CPTs

·           Actively support and contribute to the delivery of CA&A strategy and objectives

·           Facilitates and supports routine regulatory authority inspections

·           Participates in audits/initiatives with other AZ compliance groups

·           Manages audit requests for for-cause audits (e.g., investigator sites, TA or region specific, systems, CROs, specific compliance areas)

·           Supports and manages outsourced advice and audit activities

·           Provides compliance support to assigned Business Area through the following responsibilities:

oDevelops and maintain in-depth knowledge of the regulations and guidelines applicable to the specific BA

oDevelops and maintain awareness of the systems and activities owned by the BA and the interactions between these across BAs and in the wider business

oProvides a single point of contact for the BA for compliance advice and reviews audit and inspection feedback to support the BA in delivery of business activities as well as the development of systems and processes for future improvement

oSupports BA efforts to set and measure quality standards relevant to the BA that support further development of BA efficiency and effectiveness

·           Monitors new regulatory legislation or guidelines and maintains working knowledge of current local and international regulations and guidelines and changes to those regulations and guidelines. Assesses impact of these regulatory requirements and changes relative to clinical development and devises tactical strategy for assessment and implementation and related future requirements.

·           Implements new areas for assessment within the audit programs in line with global Q&CD strategic direction and individual TA/region strategic decisions

·           Communicates and collaborates proactively with other CA&A teams to ensure knowledge and actions required are directed appropriately to assure maximum benefit to the business

·           Builds and maintains strong customer relationships with non Clinical Development functions whose activities overlap, influence or affect compliance

·           Represents AZ in external industry forums and working groups as required

·           Contributes to training of CA&A personnel and mentors less experienced CA&A personnel

Minimum Requirements –Education and Experience

Functional & Business knowledge

·         Bachelor Degree level

·           Proven broad experience in Industry/Clinical Development with experience in  Assessment/Advice

·         Well-informed understanding of drug development and GXP activities

·         Expert knowledge of consultation and audit processes and procedures

·         Proficient knowledge of local and international regulations and guidelines and AZ SOPs

·         Willingness and ability to travel nationally and internationally

Leadership Capabilities (Level 2)

·         Passion for Customers – Engages customer in development/identification of solutions

·         Thinks Strategically – Applies a broad perspective, uses insight to challenge and adapt current approaches

·         Acts Decisively – Makes effective decisions under pressure and in the absence of complete information

·         Drives Performance – Holds others accountable.

·         Works Collaboratively – Respects and integrates diverse views

·         Develops People and Organisation – Provides coaching and feedback in the moment

Internal and External Contacts/Customers

·      Internal:  Clinical Development, Marketing Companies, Regulatory Affairs, other internal QA functions, at global and local locations

·      External:  Regulatory Authority Inspectorates, Clinical Investigators, External Service Providers, Industry Peers, Professional QA Organisations

Reporting Relationship

·    Reports to:  CA&A Section Director

·    Direct Reports - none

·    Indirect Reports - none

5.  Data Management Project Leader (Operations Department)

Description:

Provide leadership in the planning and delivery of Data Management deliverables to time, cost, and quality and DM strategic direction to drug projects in the use of DM standards and technology.  To interface between the CPT, SDT and the DM Centre to ensure seamless delivery of project DM components and quality delivery and adherence to global and project standards.  The DM Project Leader will be aligned to one or more drug projects dependant on size and scale of the project DM deliverables and will take global accountability.

Accountabilities/Responsibilities:

• Provide support and expert DM advice to the CPT, SDTs and DMC roles regarding the DM activities and deliverables to ensure effective delivery of the DM service. Provide expert DM activities and project standards advice to EPMT, CPA as required (to include project standards definitions)
• Project related DM activities, technology and standards:

o   Ensure quality and consistency of DM components across the project(s)

• Provide DM input to the development of  clinical project Standards and information  regarding DM standards and technology

o   Ensure DM deliverables align with the required information standards for CPT deliverables, eg Programming standards and Information Strategy Provide DM and data collection standards expertise to project standards team  Coordinate development of project DM standards and ensure utilisation by the SDTs   

o   Provide DM technical expertise and consultancy in the selection and use of systems (e.g. WBDC, ePRO, dECG and other data capture tools) as appropriate 

• Review project DM documentation and specifications as needed to ensure consistency with AZ strategies and standards
• Review, assess and manage DM Centre delivery against KPIs , the SDTs delivery of rKPIs and overall AZ and DM Centre performance for the studies within the project(s). 

·         Working with the DMC, input to the production of the DM Service Order and study costs for studies being processed at the  DM Centre

·         Manage escalation of  DM issues to the DM Operational Review Board and implementation of solutions within AZ

• Ensure study teams utilize project standards by:

§   Working with study teams to understand, explain and resolve variances from global and project standards when study requested variances arise

§  Working with standards governance organization to handle project (study) standards variance requests

• Lead, coordinate and ensure transparency and consistency of CPT, SDT and DM center activities including:
• Provide the DM Centre with AZ project planning information (scheduling of the studies, volumes, timelines etc.) Facilitate DM related requests and issue escalation/resolution between the SDTs and the DM Center e.g. audit requests, quality issues
• Monitor, manage and resolve escalated issues related to delays to DM Centre deliverables

o   Input to the DM related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance (CQA)

·         Assess AZ Clinical DM needs and improvement potential and recommend changes to operating model

·         Retain/Build intellectual property as it relates to DM activities/standards for input into strategic decisions (e.g. input into System and tool strategies) 

• Provide input to the provision and prioritization of business requirements for process & technology enhancements

·         Provide input to the global development and application of DM standards

• Provide strategic DM expertise to global Clinical Initiatives
• Lead/input to global DM capability initiatives        
• Maintain a constant awareness of trends/changes in external DM Strategies and technologies and advise management on areas of improvement
• May be asked to take on a global standards role to support the CISGO

Minimum Requirements –Education and Experience

·         University degree or equivalent experience

·         Minimum of 7-10 years experience of working in Data Management in the pharmaceutical industry

·         Demonstrated comprehensive knowledge and experience of most (or relevant ) aspects of Data Management in the Pharmaceutical industry

·         Experience of working with external partners

·         Demonstrated project management skills

·         Demonstrated leadership skills

·         Proven experience in developing tactical/operational plans

·         Comprehensive knowledge of clinical and pharmaceutical drug development process and associated GCP

·         Comprehensive knowledge of regulatory requirements as they relate to DM activities

·         Comprehensive knowledge of database structures and of capturing and storing clinical information

·         Comprehensive knowledge of clinical data standards eg SDTM

·         External awareness of DM technologies and technical expertise in industry

·         Multi-phase experience in Clinical Research and experience of different Therapeutic Areas

Skills and Capabilities

·         Excellent organisational and analytical skills

·         Ability to work with a large degree of independence

·         Demonstrated expertise in risk management and contingency planning

·         Ability to work effectively with external partners

·         Ability to negotiate and influence others across multiple organisational areas

• Excellent written and verbal communication skills

·         Effective problem and conflict resolution skills

·         Ability to understand the impact of technology on projects

·         Strategic thinking

·         Ability to work in a global team environment

·         Cultural sensitivity and diplomacy

·         Ability to manage change

Organizational Behaviors

·         Customer Focus

·         Planning and Organizing

·         Delivery Focused

·         Performance Driven

·         Passionate About Winning

·         Results Orientation

·         Conflict resolution

Internal and External Contacts/Customers

Internal Customers

• CPT members
• SDT members
• EPMT
• DM Executive Steering Committee members
• DM Operational Review Board members

• Clinical Information Science staff and line managers
• Marketing companies

• Standards organization members
• Information Strategy Directors
• BA organisation

External Customers

• External DM providers

6. Feasibility and Recruitment Specialist

Description: 

Facilitate and support study feasibility and study recruitment planning activities. Drive improvement of patient recruitment KPIs by supporting global and MC study teams in the forecasting, tracking and risk mitigation activities for their studies. Serve as subject matter expert and support to global study teams and Marketing Companies to drive alignment, standardization and improvement of patient recruitment processes, tools and performance. 

Accountabilities/Responsibilities:

·         Contribute operational, commercial, medical insight to recruitment option development for business cases in cooperation with Feasibility and Recruitment Leader

·         Formulate and validate patient-centric hypotheses for insight with potential study subjects, caregivers and Investigators in collaboration with Commercial/Medical for study feasibility, allocation and site selection

·         Facilitate study feasibility in collaboration with study team and MCs and take advantage of streamlining opportunities e.g.:

• use previous studies and other historical information
• central data sources of sites and patient populations

·         Support and align globally program/study recruitment contingency plans e.g. opening/closing countries, acceleration of recruitment,

·         Prospectively support and coach the Study Delivery in execution, maintenance of approved recruitment options

·         Provide targeted support, specialist expertise and align globally study recruitment planning and associated processes e.g. country allocation, fSMA, recruitment planning, feasibility, site selection, activation, cooperation with sites with the aim to deliver global patient recruitment KPIs

·         Contribute to development of global patient recruitment KPIs

·         Follow-up, support and drive global patient recruitment KPIs in Clinical Operations

·         Contribute to policies/processes/procedures, toolkits and education and learning to ensure standardized & seamless delivery of global recruitment goals according to AZ policies and procedures. 

·         Serve as the subject matter expert within the Study Delivery organization on study recruitment for clinical studies;

• Champion recruitment and retention practices, toolkit and processes within Study Delivery and MCs
• Collaborate with internal stakeholders to facilitate knowledge transfer, standardization, global alignment and best practices
• Partners and supports AZ MCs recruitment experts to enhance subject and investigation recruitment worldwide
• Manage/contribute to process improvement projects in patient recruitment area

·         Ensure AZ CRC/OPAL database accurately tracks MC allocation, resource utilization and forecasts

·         Contribute to budget update processes with relevant input

·         Maintains awareness of marketplace activities, policies, trends, technology and information affecting the business and organization to support continued improvement of clinical recruitment efforts adhering to company policies

·         Support the Feasibility and Recruitment Leader in securing resources to execute programs and recruitment options through analysis of supply and demand and partnering with CRRs and CDDs

Minimum Requirements - Education and Experience

·         Bachelors degree in relevant field (e.g. life sciences, business management, project management)

·         5+ years experience from clinical R&D operations, either a research site or MC.

·         Clinical trial patient and investigator recruitment and retention experience

·         Proven experience in project and budget management

·         Experience working with Global teams

Preferred Background

·         New product development experience within the pharmaceutical industry

·         International experience

Skills and Capabilities

·         Proven motivation and delivery focus in order to accomplish individual, team and organizational objectives.

·         Extensive knowledge and a good understanding of project management tools, cost systems and processes.

·         Excellent written and verbal communication skills, collaboration and interpersonal skills.

·         Cultural sensitivity when dealing with a wide range of key customers.

Organizational Behaviors/Leadership capabilities

·         Passion for Customers –

·         Works Collaboratively –

·         Drive Performance –

Internal and External Contacts/Customers - Some examples of contacts/customers are:

Internal

·         Feasibility and Recruitment Leader

·         Study Delivery teams and leaders

·         Leaders within Clinical Operations

·         CRR/MC  teams and leaders

External - Some examples of contacts/customers are:

·         Investigators and Key Opinion Leaders

·         Academic Institutions

·         Vendors

Reporting Relationship

·         Direct Reports - NA

·         Indirect Reports - NA

7.Study Associate (Operations Department)

Description:

Participate in the coordination of and contribute to operational (activities to ensure quality and consistency of Operations deliverables to time, cost, and quality objectives from Study Specifications (SS) through study close-out activities and Clinical Study Report (CSR).

Accountabilities/Responsibilities:

• Contribute to clinical study start-up, execution, close-out and reporting
• Collect, review and track regulatory and other relevant documents. Interface with Investigators, Strategic Partners, Marketing Companies and internal staff during the collection process to support effective delivery of a study and its regulatory documents through finalization of the Clinical Study Report (CSR)
• Initiate and lead the set-up of the Study Master File (SMF) including tracking of documents. Maintain and close the SMF ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance
• Initiate and maintain production of study documents, ensuring template and version compliance
• Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in GEL
• Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities
• Plan and proactively collate the administrative appendices for the CSR
• Interface with Data Management Centre and/or Data Management Enablement representatives to facilitate the delivery of study related documents
• Provide input into non-drug project work including training activities and development of procedures as needed
• Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, ISSIS, Clinical Partners Portal and eRoom) and support others in the usage of these systems
• Manage and contribute to coordination and tracking of study materials and equipment
• Coordinate administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs
• Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, ISS review meetings, monitor meetings, Investigator meetings. Liase with internal and external participants and/or vendors
• Prepare, contribute to and distribute presentation material for meetings, newsletters and web-sites
  
  

Minimum Requirements –Education and Experience

·         Level of education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers

·         Proven organizational and analytical skills

·         Previous administrative training/experience

·         Computer proficiency

·         Excellent knowledge of spoken and written English

Skills and Capabilities

·         Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines

·         Ability to develop advanced computer skills to increase efficiency in day-to-day tasks

·         Excellent verbal and written communication and presentation skills

·         Demonstrate ability to work independently, as well as in a team environment

·         Ability to prioritise and manage multiple tasks with conflicting deadlines

·         Good interpersonal skills and ability to work in a team environment

·         Willingness to travel both domestically and internationally

·         Proactively identify risks and possible solutions

·         Demonstrate analytical thinking, concern for standards, concern for impact, good team skills including cooperation, willingness to learn from others, sharing relevant information, adaptability, self-control, tenacity conflict resolution skills and the ability to influence others

·         Develop knowledge of therapy area through experience and review of scientific literature

·         Ability to prepare presentation materials

·         Demonstrate professionalism and mutual respect

·         Willingness and ability to train others on study administration procedures

·         Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities

Organizational Behaviours

• Passion for customers
• Think strategically
• Act decisively

·         Drive performance

• Work collaboratively
• Develop people & organization

Internal and External Contacts/Customers - Some examples of contacts/customers are:

·         Operations  personnel

·         Data Management Centre representatives

·         Clinical Project Team and therapy area personnel

·         Clinical Development personnel

·          Clinical Pharmacology Alliance personnel

·         External service providers and strategic partners

·         Study Site personnel

·         Marketing Company personnel

·         Regional Monitoring personnel

Other Skill Centres as appropriate

8. Study Leader (Operations Department)

Description:

Plan and Lead the Delivery of all components of a clinical study to time, cost, and quality from Study Specifications (SS) through study closeout activities and Clinical Study Report (CSR).  Leads the study delivery team and is a key player during the whole study process and responsible for the consistency during the course of the study. The position requires regular contact with persons of influence and decision-making authority within Operations, as well as other global and regional functions.  The individual will demonstrate considerable tact, discretion and persuasion to obtain desired outcomes while maintaining effective, positive, organizational relationships. 

Accountabilities/Responsibilities:

·         Plan and Lead the delivery of all components of a clinical study to time, quality, budget, project standards, company quality standards, and scientific requirements from Study Specifications (SS) through CSR. 

·         Leader of the study delivery team, key player during the whole study process, and responsible for consistency during the course of the study

·         Contributes in steering committees, submission assembly teams, regulatory defense teams, and contribute to Advisory Boards as necessary

·         Operational study level feasibility, development of recruitment strategies, and the delivery of the approved Clinical Study Protocol

·         Work with Line Managers to identify resource need and secure resources from various departments to ensure flexible and timely formation of the Clinical Study Teams and progression of deliverables

·         Agree on participating markets using the appropriate study allocation process

·         Liaise with Marketing Companies, strategic partners, external service providers, and academic clinics to identify and resolve operational feasibility issues, and facilitate study start-up activities

·         Forecast and day-to-day management of study timelines, budget, materials and development of detailed study level plans and feasibility assessment

·         Lead and implement globally agreed operations  and Clinical Development strategies including process and technology related to Operations

·         Plan and lead activities associated with audits in liaison with CA+A; contribute to regulatory inspection strategy teams as required

·         Participates in the negotiations and the selection process of  external service providers

·         Develop & manage contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate

·         Lead preparation and delivery of study documents (e.g. Protocols/amendments, documents detailing study delivery data management activities, etc.)

·         Ensures operational input from other functions (e.g. Regulatory, Investigational Product Supply, etc.)

·         Track and manage to agreed study timelines, budget, and resource and ensure the update of appropriate systems (e.g. IMPACT, ACCORD, ISSIS)

·         Establish and maintain key interactions with stakeholders such as CPT, DMPK, IPS, RA, PS&L and Dev IS

·         Plan, lead and ensure appropriate training is achieved at Investigator/monitor meetings

·         Coordinate and/or contribute to timely delivery of Operations  components of submissions to regulatory authorities (e.g. CSRs, CTDs, INDs, IND annual reports)

·         Work with other members of the organization to share knowledge, experiences and best practices

·         Collaborate with study delivery Line Management to drive best practices and provide development for staff within the projects; In liaison with Line Management, support competency development through mentoring, training, and team support 

·         Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate skill center managers

·         Lead and/or provide input into non-project work, training activities, and development of procedures as needed

·         Demonstrate willingness to take on any level project activity consistent with current or past experience in support of study delivery.

Minimum Requirements –Education and Experience

·         Bachelor’s degree in biological science or healthcare-related field

·         Experience in the pharmaceutical industry working in an environment of clinical study delivery/clinical development processes

·         Demonstrated leadership ability in a team environment

·         Experience in project management methodologies

·         Advanced knowledge of the clinical study and drug development processes, GCP/ICH guidelines

·         Excellent verbal and written communication skills

·         Budgetary and resource management planning experience

·         Willingness to travel both domestically and internationally

·         Excellent knowledge of spoken and written English

·         Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

Skills and Capabilities

·         Ability to lead cross functional working groups and teams. Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment

·         Effectively plans, coordinates and facilitates delivery of team objectives

·         Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives 

·         Demonstrates appropriate Project Management skills (including scope, budget, timeline, and resource management and use of associated tools)

·         Demonstrates operational expertise in risk management and contingency planning

·         Applies industry best practices to the design and execution of clinical studies to improve time and cost efficiency

·         Act as role model in line with AZ core values and behaviors

·         Has an appropriate understanding of disease state and familiarity with the latest research and thought leaders

·         Demonstrates an extensive knowledge of the clinical study and drug development process, GCP/ICH guidelines and SOPs

·         Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of AZ and Operations  systems/software in an e-enabled environment

·         Demonstrates strategic influencing, concern for standards, and tactful persuasion to obtain desired outcomes while maintaining effective, positive, organizational relationships.

·         Demonstrates conceptual, analytical and strategic thinking

·         Effective problem and conflict resolution skills and proven team focus

·         Demonstrates good team skills including cooperation, concern for impact, willingness to learn from others, and sharing of relevant information

·         Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills

Organizational Behavior

Passion for Customers

Thinks Strategically

Acts Decisively

Drives Performance

Works Collaboratively

Develops People and Organization

Internal and External Contacts/Customers - Some examples of contacts/customers are:

·         Clinical Development  Director

·         Operations  Line Management

·         Therapy Area personnel

·         Clinical Development personnel

·         Cross-functional Operations  personnel

·         Regional Monitoring personnel

·         Study Specific advisory and/or steering committees

·         Marketing Companies/Clinical Research Region personnel

·         Other R+D Hubs

·         Investigators and Key Opinion Leaders

·         Study Site personnel

·         Academic Institutions

·         Cooperative Groups (e.g. Oncology)

·         External service providers and strategic partners

·         Regulatory Authorities

9. Study Management and Operations Group Manager

Description:

To lead, develop and provide direction to Study Management and Operations personnel to enable delivery of drug projects and non-drug projects by providing expertise (project, TA scientific, technical and operational knowledge). Working in collaboration with the CDD and other line managers in all hubs regarding resourcing in support of delivery of clinical study programs from Study Design Concept to CSR and study closed and archived. The role holder will also be responsible for embedding consistent ways of working across hubs and building the study management and operations capabilities.

Accountabilities/Responsibilities

• Provide appropriately skilled Study Management and Operations personnel to study delivery teams to ensure delivery of clinical studies to time, budget and quality through an integrated skill set model in accordance with clinical performance targets
• Provide expertise and direction to support direct reports with proactive problem/risk identification, solution building and issues resolution to facilitate achievement of objectives on time and to appropriate quality.
• Provide input to and ensure global adoption of globally agreed Clinical Operations and Clinical Development strategies
• Provide a quality review of deliverables of direct reports.
• Act as first line support for GCP and AZ processes
• As change agents drive consistent implementation of globally agreed Clinical Operatoins and Clinical Development strategies including process and technology related to the delivery of studies.
• Promote and encourage innovation and creativity by bringing suggestions/good examples to hub leadership
• Work with Hub Directors within Study Management and Operations to support Capacity Management, achieving accurate resource forecasting, analysis and solution building to efficiently and flexibly resource study teams
• Provide skills development and create opportunities for staff within the projects, drug and non drug
• Contribute to the business through drug/non drug project or departmental activities.
• Contribute actively to hub leadership
• Management of the hub contracts and associated budget as defined by Hub Director.
• Lead and support change by encouraging diversity of solutions that are value demonstrated
• Promote and encourage communication within and across Hubs and Clinical Development
• Role model and embed performance driven culture
• Recruit and retain Study Management and Operations personnel
• Provide performance management, performance assessment and reward proposals for direct reports
• Ensure compliance to ethics, policies and standard procedures

Minimum Requirements –Education and Experience

·         Bachelor’s degree required, preferably in medical or biological science, or related subject or equivivalent qualification or experience.

• 5 or more years of experience in the pharmaceutical industry working with delivery of clinical studies
• Line management experience
• An understanding of the therapeutic areas related to AstraZeneca’s products
• Comprehensive knowledge of clinical and pharmaceutical drug development process

Skills and Capabilities

·         Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives

·         Manages change with a positive approach to the challenges of change for self, team and the business. 

·         Sees change as an opportunity to improve performance and add value to the business

·         Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

·         Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills

·         Good problem solving and conflict resolution skills

·         Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment

Organizational Behaviours

            Passion for Customers

            Drives Performance

Develops People and Organization

            Works Collaboratively

            Acts decisively

            Thinks strategically

Internal and External Contacts/Customers

• Requires close collaboration with CDDs in Clinical Project Team regarding project delivery, resourcing as well as people aspects and performance management.
• Hub Directors
• Study Teams

10. Study Operations Specialist

Description:

 Lead and coordinate activities that ensure quality, consistency, and integration of study data and progress operational deliverables to time cost and quality objectives from Study Specifications (SS) through study close-out activities and Clinical Study Report (CSR). Work with and lead cross-functionality, with internal and external partners, on global studies across different phases of drug development and different therapy areas.

Accountabilities/Responsibilities:

·         Coordinate operational aspects of AZ and Investigator Sponsored studies from SDC/Proposal through CSR/Publication.

·          Lead and/or participate in activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives

·         Interface with Data Management Center representatives/Data Management Enablement,  to facilitate the delivery of study data

·         Establish and maintain interactions with key stakeholders including the facilitation of communications with MCs, Strategic Partners, Academic clinics and investigational study sites, as appropriate, and external service providers (Third Party Vendors) to identify and resolve operational feasibility issues, facilitate study start-up activities, and ensure Operations deliverables to time, budget and quality objectives

·         Implement globally agreed Operations and Clinical Development strategies including processes and use of technical systems related to Operations

·         Contribute to protocol development and the development of other Operations  documents as appropriate as well as any updates/amendments to those documents

·         Provide input to data management documents (e.g. Case Report Form, Data Management Plan)

·         Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and in the development of the Source Data Verification (SDV) plan and other applicable Operations documents

·         Contribute to review of new/amended/unique project Clinical Information Standards Governance Organisation (CISGO) Standards Repository Components

·         Ensure timely entry and/or update appropriate information into AstraZeneca tracking and communication tools (e.g. IMPACT, ISSIS and Clinical Partners Portal)

·         Ensure the supply of study materials and Investigational product by liasing with Investigational Product Supply or external service providers as appropriate

·         Support the study delivery team and Clinical Advice and Assurance (CA+A) in the development of and implementation of audits and regulatory inspections

·         Contribute to the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meetings, Investigator Sponsored Study Review and Oversight Team (ISSROT) meetings

·         Monitor study conduct and progress, proactively identifying to and resolving with the SD Leader, issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives

·         Monitor and support clinical study sites as applicable

·         Contributes to steering committees, submission assembly teams, regulatory defence teams, and Advisory Boards as necessary

·         Contribute to ad hoc team productivity and efficiency by providing direction and facilitating good team dynamics

·         Provide input into non-drug project work including training activities, and development of procedures as needed

Minimum Requirements –Education and Experience

·         Bachelor of Science degree in related discipline, preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields

·         Experience working on clinical studies, across different phases of drug development

·         Four or more years of relevant industry or health care experience

·         Proven organizational and analytical skills

·         Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to Study delivery operational activities

·         Computer proficiency

·         Excellent knowledge of spoken and written English

Skills and Capabilities

·         Demonstrates ability and willingness to work and lead cross-functionally, e.g. with internal and external partners, on global studies, across different phases of drug development or different therapy areas

·         Good understanding of Clinical data flow

·         The ability to develop advanced computer skills to increase efficiency in day to day tasks

·         Excellent verbal and written communication and presentation skills

·         Demonstrates ability to work independently, as well as in a team environment

·         Proven ability to prioritize and manage multiple tasks with conflicting deadlines

·         Excellent interpersonal skills and proven ability to facilitate team building and team work

·         Willingness to travel both domestically and internationally

·         Demonstrates sound knowledge of GCP, AZ Procedural documents, as they pertain to Study delivery systems and processes

·         Proactively identifies risks and issues and possible solutions

·         Demonstrates high standards and uses tactful persuasion to obtain desired outcomes while maintaining effective, positive, organizational relationships

·         Develops knowledge of therapy area through experience and review of scientific literature, and demonstrates ability to learn new therapy areas

·         Demonstrates ability to prepare and deliver study related training materials

·         Demonstrates ability to plan, coordinate, and facilitate internal and external meetings

·         Demonstrates professionalism and mutual respect

·         Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities

·         Demonstrated Project Management skills (e.g. leading delivery team)

·         Excellent mentoring skills and ability to develop others

Organizational Behaviours

·           Passion for customers

·           Thinks strategically

·           Acts decisively

·           Drives performance

·           Works collaboratively

·           Develops people & organisation

Internal and External Contacts/Customers - Some examples of contacts/customers are:

·         Operations  personnel

·         Data Management Centre

·         CPT and therapy area personnel

·         Clinical Development personnel

·         External service providers and strategic partners

·         Study Site personnel

·         Marketing Company personnel

·         Other R+D Hubs

·         Regional Monitoring personnel

·         Other Skill Centers as appropriate