Sr Manager, Medical Research Operations

Company Description

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine.

Together, we pioneer. Together, we thrive.

Job Description

About This Role

The Sr. Manager, Medical Research Operations (MRO) leads Study Management Teams (SMTs), provides clinical study management expertise and oversight for the execution of post- approval drug research. In this role, the successful candidate will act as the operational partner in driving data generation program planning and execution.  Working across late-stage development and marketed products, the incumbent will drive operations for Phase 4 Observational studies, patient registries, outcomes research, and real-world evidence programs. Activities include study and program planning and budgeting, SMT leadership and line function/ stakeholder management, contracting, start-up, vendor (including CROs) management, site, and patient registry 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 Neuropsychiatry; other disease areas may be assigned.

What You’ll Do

• Drives the overall study management strategy for specific studies.  Provides study leadership for the program in close collaboration with other leaders and stakeholders
• Manages proposal submissions to governance, budgeting, contracting (including liaising with Legal), and oversees study execution including milestones
• Leads SMT, chairs regular meetings, performs cross-functional stakeholder management (including Safety and Regulatory) and supervises CTC (clinical trial coordinator) tasks including writing meeting minutes
• Manages the budget of assigned studies: including forecasting, ongoing tracking, and reconciliation in collaboration with Finance.
• Partners with Data Managers, Statisticians, Epidemiologists and Digital Health Solutions experts to build the database/ data collection platforms and oversee digital data capturing tools
• Communicates with Medical Directors, Medical Science Liaisons, medical managers, and external investigators on assessment of scientific relevance and feasibility, and provides feedback for proposal improvement
• Develops external partnerships and engages with Investigators and manages sites and patient registries in collaboration with Medical Directors and scientific experts
• Takes ownership of vendor service procurement and vendor oversight: including CROs, ePRO providers, analytical labs, and any other Third Parties
• Liaises with global departments to ensure all current active studies are appropriately tracked and documented in the Medical Affairs Research System
• Coordinates with internal Biogen process, infrastructure, and compliance colleagues to ensure appropriate SOPs related to data generation, analysis, and dissemination are followed

Who You Are

You have a  Bachelor's degree in a relevant discipline (Master's degree preferred) and a minimum of 10 years of clinical research experience and Project Management within CRO or Sponsor. You are passionate about Post-marketing observational studies, Real-world data generation and patient registries.

Qualifications

Required Skills

• Strong Project Management skills including risk assessment and contingency planning and study budget management
• Demonstrated ability influence and manage teams
• High degree of learning agility
• Combination of critical thinking and operational know-how
• Demonstrated success in working independently
• High level of customer orientation awareness and focus
• Strong experience with CRO oversight and SMT leadership, especially in late phase and observational clinical research and management of patient registries.
• Exceptional analytical, problem-solving, and troubleshooting abilities.
• Strong written and verbal communication skills.
• Fluency in English

Preferred Skills

• Neuropsychiatry (Depression in particular) disease research
• Experience with electronic and digital data capturing platforms and Digital Health Solutions (i.e.: eCRF, ePRO, eCOA)

Additional Information

All your information will be kept confidential according to EEO guidelines.