AbbVie Program Manager, Investigator Initiated Studies in Lake County, Illinois
The Program Manager, Investigator Initiated Studies plans and manages overall external the investigator research program, establish consistent practices across all Therapeutic Areas. Plan and manage overall investigator initiated research program across all functional areas within budget, headcount and timelines. Acts as the research operations team for U.S affiliate to ensure tactical execution needs are met.
Key Responsibilities Include:
- Manages team including performance management, growth planning, professional development as well as succession planning in the team. Provide leadership and guidance to the medical research support staff.
- Operational chair for cross-functional scientific review committee responsible for evaluation of investigator initiated research proposals. Ensure committee composition and actions are aligned with the process and procedure requirements.
- Forecast product supply requirements. Work with clinical drug supply management to manage inventories and ensures global shipment of product
- Monitor the operations related systems and educational needs of internal and external stakeholders to maintain compliance with AbbVie's policies and procedures, as well as extremal healthcare law throughout the process
- Champions operational excellence to provide continuous improvement of processes and sharing of best practices and participates in efforts to improve agility in research
- Actively monitor the clinical and regulatory environment within the context of investigator initiated research and translate learning into strategy, policy and process, as needed
- Ensure US affiliate needs are met for research execution including confidentiality disclosures, contracts, trial management system updates and documentation.
- Approves study budgets, maintaining financial tracking and approves invoices
- Minimum of a Bachelor’s degree is required, with a preference for science or biomedical discipline
- Master’s degree, advanced education and/or training preferred
- 10-12 years of experience in Pharmaceutical industry.
- Prior people management experience is required
- Prior experience in investigator-initiated research and/or clinical study management is required
Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Travel: Yes, 10 % of the Time
Req ID: 1703786
Equal Opportunity Employer Minorities/Women/Veterans/Disabled