Our client is looking for an Evidence Delivery Manager (EDM is primarily a study leadership role) to lead the operational delivery of global clinical studies designed to generate medical evidence to support the use of medicines.
The key responsibilities will include:
* Support delivery of projects to agreed timelines (scorecard), within the approved budget and according to AstraZeneca quality standards.
* Support global oversight over the operational study start up, implementation and closure and ensure inspection-readiness
* Support implementation of study-related change management within business strategy, e.g. assessment of scope changes.
* Ensure Compliance with AZ Procedural Documents, Standards and Policies, international guidelines and local regulations at any time, and report compliance breaches
* Undertake feasibility assessments with internal and external stakeholders
* Manage study systems reporting
* Provide input into the selection of External Service Providers (ESPs), including Clinical Research Organisations (CROs)
* Support strategic handover meetings and kick off meetings
* Perform CRO oversight to help ensure project delivery within time, cost and quality
* Collaborate with CRO/ESP to ensure the study operational aspects are effectively undertaken and that they have clear remits for delivery
* Manage study specific issues and escalations with ESPs/CROs.
* Support/coordinate protocol development and finalization
* Support Project team set-up and study sourcing activities
* Support effective collaboration with the scientific/medical counterpart, the Epidemiologist/Medical Affairs Leader (MAL) respectively, as well as other internal cross functional global roles
* Report study updates for areas of responsibility from a time, cost and quality perspective to internal stakeholders (e.g. Evidence Delivery Associate Director, EDAD).
* Support implementation and upkeep of an effective communication approach, as well as roles and responsibilities between the Medical stakeholders, local AZ and External Service Providers.
* Coordinate efforts/input of the external scientific community (e.g. (International Coordinating Investigators, Steering/Executive Committee) during project design and delivery
* If leading a study: develop and maintain the overall study budget (internal and external study costs)
* Ensure transparency over areas of budget responsibility by updating through relevant systems (s.a. ACCORD) and platforms (PPC meetings) and obtaining approval for budget changes
* Work with procurement on project agreement and manage subsequent out of scope changes for ESP/CRO
* Manage and reconcile Contracts, POs and invoices
* Support financial audit readiness and Sox attestation as needed
The ideal candidate will hold a Bachelors degree or equivalent in a medica. Biological or related discipline with relevant clinical/medical experience in the pharmaceutical industry. You will also have a good understanding of the drug development process and will have previously managed projects successfully.
Proven ability to work effectively with Clinical Research Organizations/External Providers and to interact widely and effectively within the company across regions, functions and cultures is also essential