Medical Evidence & Observational Research Manager
At AstraZeneca when we see an opportunity for change we seize it and make it happen, because an opportunity no matter how small can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential.
The Medical Evidence & Observational Research Manager is responsible for the activities required in the start-up and delivery of an evidence generation portfolio, including Company Sponsored studies, Externally Sponsored studies and Early Access Programs. The MEOR Medical Evidence Manager coordinates and supports cross-functional activities, interacting with both global and local Medical Affairs organizations and those external to the Company (e.g. CRO, Sponsor Institutions and Investigators).
The MEOR Manager monitors compliant and appropriate adherence with all relevant Company policies and procedures and local/ regional regulatory and legislative guidance.
- Responsible for the local management and coordination of ESR studies for a given country or region.
- Acts as a point of contact for MC operational research enquiries, signposting MC to appropriate guidance.
- Supports the review of ESR proposals to enable a timely, consistent and thorough approach to evaluation e.g. gathering required data from MC, and review committee members such as Patient Safety, Regulatory, Supply chain, Medical.
- Lead the development, baselining and maintenance of project milestones, revising all project planning, in conjunction with MC when necessary, in light of changing needs and requirements to ensure that deliverables continue to be efficiently and effectively met.
- Leads operational aspects of ESR projects in conjunction with the clinical teams, ensuring compliance with project management guidelines, external regulations and internal processes and policies to enable the delivery of high quality Externally Sponsored Collaborative Research (ESCR).
- Tracks all project KPI’s from a time, cost and quality perspective, providing progress reports to MEOR stakeholders.
- Identify risks and escalating issues of non-performance and non-compliance to the appropriate person.
- Maintain quality and accuracy of data within the ESR registry and management tool (VisionTracker) on a daily basis and completeness of documentation to enable teams to make effective business decisions.
- Lead operational set-up and delivery for your area of responsibility; either defined studies or a sub-set of study responsibilities.
- Ensure the development and implementation of study risk mitigation plan and actions for your area of responsibility.
- Manage activities to the agreed KPI’s: time, cost and quality.
- Manage effective collaboration with internal stakeholders such as the Operations Lead (OL), Delivery Director (DD), Epidemiologist/ Medical Affairs Leader (MAL) and other internal functions, for example, to assess the impact of project changes on KPI’s.
- Collaborate with External Service Providers (ESPs) and Clinical Research Organisations (CROs) on the implementation and delivery of studies, ensuring an effective communication plan is implemented and that roles and responsibilities between parties are understood.
- Act as point of contact for AstraZeneca Marketing Company (MC) stakeholders, ensuring their commitments are delivered.
- Repot on project status (using Company systems such as IMPACT and VisionTracker) and participate in project planning and control activities to ensure project plans remain up to date.
- Manage project finance within agreed threshold limits, keeping track of project budget on a continuous basis, maintaining financial management systems (such as ACCORD and OPAL) and ensure transparency with budget holders by obtaining approval for any proposed budget changes.
- Monitor compliance and ensure reporting of issues as necessary.
- University degree (or equivalent) preferably in medical or biological sciences or a discipline associated with clinical research. Advanced degree is preferred.
- Experience within the pharmaceutical industry or similar organization or academic experience.
- Demonstrable understanding of the drug development process in various phases of development and therapy areas across all stages.
- Demonstrable understanding of the relevant clinical research guidelines, e.g. GCP.
- Project Management certification is desirable, or demonstration of project management skills including scope, budget, timeline, and resource management and use of associated tools.
- Evidence of working effectively with both internal and external stakeholders across regions, functions and cultures in a matrix organization.
- Experience and/ or knowledge of operational compliance for ESR.
- Exhibit AZ Leadership Capabilities at level 2: Drives Accountability, Works Collaboratively and Strategic Leadership.
- Ability to demonstrate AstraZeneca values in their day to day work.
- Proactive communicator in English (written and verbal skills).
- Demonstrated ability to set and manage workload priorities, resources, performance targets and project initiatives for a given project(s).
- Ability to identify and champion more efficient and effective methods/processes whilst operating with required policies and regulations.
- Flexibility and adaptability.
- High levels of enthusiasm and energy.
- Strong work ethic and integrity standards.
Next Steps – Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.