Evidence Delivery Manager
Wilmington, Delaware 19850
$61 per hour
As the Evidence Delivery Manager
, you will lead/support the operational planning, delivery, oversight and budget management of company and/or externally sponsored research. In this role you will help coordinate the efforts of extended team members.
In addition, you will support the continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and maintenance of guidance documents and training materials.
- Support and coordinate protocol development and finalization Manage Study Governance as well as all internal, study governance processes.
- Provide input into the selection of External Service Providers (ESPs), including Clinical Research Organizations (CROs)
- Support strategic handover meetings and kick off meetings
- Help ensure project delivery within time, cost and quality
- 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.
- Coordinate efforts/input of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during project design and delivery
- Develop and maintain the overall study budget (internal and external study costs)
- Work with procurement on project agreement and manage subsequent out of scope changes.
- Manage and reconcile Contracts, POs and invoices
- Supports the review of ESR proposals and protocols to enable a consistent, high quality approach to evaluation
- Manage across a range of global and local cross-functional stakeholders to ensure all obligations and responsibilities are met
- Bachelor’s degree required preferably in medical or biological science or equivalent by experience.
- Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area.
- Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.
- Scientific awareness and extensive knowledge of observational study guidelines and SOPs
- Extensive knowledge of early and late stage Pharmaceutical Development
- Ability to effectively work with Clinical Research Organizations/External Providers.
- Proven ability to interact widely and effectively within the company across regions, functions and cultures.
- Experience and knowledge within compliant management of Externally Sponsored Scientific Research
- Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
- Open to periods of travel
Please submit your resume for consideration!