Specialist, Evidence Project Management

The Medical Evidence Delivery Team within Oncology Business Unit (OBU) is responsible for strategic planning and operational delivery of interventional and observational AstraZeneca sponsored studies (AZ studies), externally sponsored scientific research (ESR) and early access programs (EAP) in order to generate the evidence to build confidence in and provide access to AstraZeneca therapies for patients in need.

Specialist, Evidence Project Management (Spec EPM) will support the Associate Director, Evidence Project Management (AD EPM) and Manager, Evidence Project Management (Mgr EPM) in the operational delivery and oversight of company sponsored evidence studies and/or early access programs (EAP) to time, cost and quality. The Spec EPM works cross-functionally with internal and external partners to deliver certain aspects of the clinical study as delegated by the AD EPM/Mgr EPM and in accordance with the clinical outsourcing model (EMPOWER), current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices and in line with AZ values and behaviours.

Responsibilities:

Executes activities enabling AZ to fulfil sponsor oversight responsibilities and to maintain inspection-readiness, including
- Maintain Study Inspection Readiness Tool
- Coordinate and oversee periodic study-level TMF/Master File (MF) QC
- Perform Periodic TMF/MF QC on behalf of Study/EAP Management
- Customization of the study’s Expected Document List (EDL) in collaboration with the CROs
- Collaborate with extended study team to develop, maintain, and execute activities according to the study Sponsor Oversight Plan
- Ensure appropriate documentation of oversight and inspection-readiness tasks is maintained
- Ensure handover documents are created, signed and filed in TMF
- In collaboration with CRO, support creation, execution and maintenance of AZ TMF/MF Plan
• Supports key study start-up activities, in collaboration with CRO and internal functions as needed

- Internal system’s set up (VCV, SPOL, Shared mailbox, etc.)
- D-code requests
- Creation and maintenance of Study Team Charter / R&R document
- Creation and maintenance of study team contact list
- Creation and maintenance of Decision and Issue trackers Coordination & documentation of internal study team meetings
- Provide input into development of study/EAP plans and study/program documents as needed
• Support compliance and quality deliverables
- Assist recording of QIs in VQV
- Assist in audit/inspection preparation as needed
- Monthly review of the data present in PharmaCM
- Monthly review of workbooks
• Create and maintain internal study/program trackers and systems as needed, including mailboxes and collaboration forums
- Ensure new team members have access to all required systems
• Enter/maintain accurate data relating to study/EAP scope and progress on all business systems throughout the course of study every month
• Support budget management activities including
- Raise POs
- Maintain
- Support invoice reconciliation
• EAP program participation, status and tracking:
- creation of country tracker aligned with agreed country participation timelines/exit strategy
- creation and maintenance of study team contact list
- creation and maintenance of Decision and Issue trackers
- Provide program level tracking and updates
- Validate source information for stakeholder reporting
- Maintain SSI with approved protocol
- US specific local operational requirements
- Ensure EAP MF Archiving
- Active participation in CRO operational governance meetings

Requirements:

Essential:

▪ Bachelor’s degree required preferably in medical or biological science or equivalent by experience
▪ Knowledge and understanding of the clinical study and drug development processes, GCP/ICH guidelines
▪ Excellent written and verbal communication skills as well as proven collaboration and influencing skills
▪ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
▪ Demonstrated ability to collaborate as well as work independently
▪ Ability to effectively work with Clinical Research Organisations/External Providers
▪ Proven ability to interact widely and effectively within the company across regions, functions and cultures
▪ Ability to manage competing priorities

Desirable:

▪ Advanced degree in medical or biological sciences or field associated with clinical research
▪ Proven organizational and analytical skills
▪ Previous administrative training/experience