Working across late-stage development and marketed products, the Senior Manager ofMROwill drive operations for Phase 4 studies, patient registries, outcomes research, and real-world evidence programs. Activities include study and program planning and budgeting, contracting, start-up, vendor management, site management, tracking and reporting. The work is collaborative and is performed in conjunction with medical teams in both the global headquarters and at local affiliates. The initial assignment is expected to be in Alzheimer's disease; other disease areas may be assigned.
Specific responsibilities include:
- Drive the overall study management strategy for a specific program. Provide operational leadership for the program in close collaboration with other leaders and stakeholders
- Take responsibility for proposal submissions, budgeting, contracting, study management team formation, and study milestones
- Communicate with Medical Directors, Medical Research Experts, Medical Science Liaisons, medical managers and external investigators on assessment of scientific relevance and feasibility, and provide feedback for proposal improvement
- Develop external partnerships in collaboration with Medical Directors and scientific experts
- Take ownership of vendor service procurement and vendor oversight
- Liaise with global departments to ensure all current active studies are appropriately tracked and documented in the Medical Affairs Research System
- Coordinate with internal Biogen process, infrastructure, and compliance colleagues to ensure appropriate SOPs related to data generation, analysis, and dissemination are followed
- Requires Bachelors degree in a relevant life science discipline. Master's Degree is preferred.
- Minimum of 10 years of clinical research experience with CRO/Sponsor Project Management responsibility
- Strong Project Management skills including risk assessment and contingency planning
- High level of customer orientation awareness and focus
- Strong preference for experience with late phase and observational clinical research
- Alzheimer's disease research experience preferred
The SeniorManager, Medical Research Operations (MRO) provides clinical study management expertise and oversight for the execution of post-drug approval research. In this role, the successful candidate will act as the operational partner in driving data generation program planning and execution.The positionreports to the Director of MRO Study Management, and is part of Worldwide Medical Affairs. It is locatedin the Cambridge, Massachusetts USA Biogen headquarters however a remote work arrangement during the remainder of the COVID pandemic is expected.