Evidence Project Manager

Operational manager within the Country Medical Affairs Team accountable for end-to-end project management of real-world evidence (RWE) studies and data generation activities across therapeutic areas and along the product life cycle. Drives operational excellence in study planning execution vendor oversight and delivery ensuring projects are completed on time within budget and in compliance with all applicable regulations. Partners with the RWE Specialist/RWE Manager on strategic direction while owning the day-to-day operational execution risk management and cross-functional coordination necessary to deliver high-quality scientific evidence.

Responsibilities:

• End-to-end operational ownershipof RWE/non-interventional studies from start-up through close-out and archiving including timeline management resource planning milestone tracking and deliverable coordination

• Develop and maintain detailed project plans (including risk registers communication plans and RACI matrices etc.) for all active evidence generation projects

• Proactively identify risksand develop mitigation strategies escalate issues promptly to the Study Leader/MEGL with proposed solutions

• Manage competing prioritiesacross multiple concurrent projects ensuring efficient resource allocation and adherence to agreed timelines

• Track forecast and manage study budgets as directed by the Study Leader process invoices and authorize payments to vendors and investigational sites accurately and in a timely manner

• Identify inefficiencies in current workflows and propose/lead improvement initiatives aligned with required policies and regulations

• Manage outsourced study modelswith different CROs ensuring deliverables meet quality standards and AstraZeneca requirements

• Provide vendor selection support contracting processes and ongoing performance monitoring

• Establish and sustain productive working relationshipswith internal and external partners across regions and functions

• Manage study systems (VCV)

• Track study progressincluding milestones patient recruitment and trial documentation

• Support the analysis and interpretation of real-world datain close collaboration with external stakeholders and the RWE Specialist

• Effectively communicateproject plans status updates study results and lessons learned to internal and external stakeholders

• Collaborate with international and headquartershealth economics outcomes research and RWE teams to ensure alignment and knowledge sharing

• Execute and operationally manage the Evidence Generation process for MC Poland

• Ensure end-to-end preparation delivery and dissemination of AZ-generated evidence from an operational standpoint

• Maintain inspection-ready eTMFfor all assigned studies at all times

• Ensure vendor compliance through systematic VCV programme execution

• Ensure appropriate tracking of milestones for AZ studies compliance with reporting requirements and budget spend

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards

• Ensure and monitor compliance by project team members and third parties; positively reinforce the Code of Conduct and all relevant AstraZeneca Policies and Standards

• Accountability for GXP areas is expected

Expectations:

Essential

• Bachelors degree or equivalent experience preferably in medical or biological science

• Demonstrated experience in Biotech Pharma or CRO industry

• Solid knowledge of GCP/ICH guidelines and clinical study processes

• Proven experience in conducting and operationally managing RWE projects

• Hands-on experience with eTMF systems and TMF management processes

• Hands-on experience in operational governance of external service providers

• Strong project management skills including experience in start-up phases

• Experience working in outsourced models with different CROs

• Budget management experience in a clinical/RWE study context

• Ability to manage competing priorities across multiple concurrent projects

• Excellent written and verbal communication skills in English

• Good knowledge of MS Office (Word Excel PowerPoint) and project management tools

• Self-motivated analytical mindset open flexible and team-oriented personality

Desirable

• Masters degree in medical or biological science

• Project management qualifications (PMP PRINCE2 or equivalent)

• Experience in health economics and outcomes research

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.