6+ years clinical operations management experience
Expertise in good clinical practices (gcp) and ich guidelines
Proven ability to manage outsourced clinical trials with cros
The role involves independently managing one or more clinical studies to ensure delivery of protocol designs that prioritize patient focus and scientific integrity
Job Summary
The role involves independently managing one or more clinical studies to ensure delivery of protocol designs that prioritize patient focus and scientific integrity.
Candidates will be responsible for developing comprehensive clinical trial budgets, overseeing outsourced studies, and ensuring strict adherence to GCP and regulatory guidelines.
Biogen offers a competitive benefits package including up to $10,000 in tuition reimbursement, paid parental leave, and a robust 401(k) matching program.
Matching Summary
The role involves independently managing one or more clinical studies to ensure delivery of protocol designs that prioritize patient focus and scientific integrity.
Salary
Base: $141,000.00-$188,000.00; Bonus/Equity: Short-term cash bonus and long-term equity incentives available; Benefits: Medical, Dental, Vision, Life, 401(k) match, Tuition reimbursement up to $10,000
Skills & Requirements
Must-have
6+ years clinical operations management experience
Expertise in Good Clinical Practices (GCP) and ICH guidelines
Proven ability to manage outsourced clinical trials with CROs
Strong skills in developing clinical trial budgets and financial analysis
Experience chairing Study Management Teams (SMT)
Knowledge of Integrated Asset Plan (IAP) and Program Operational Plan (POP)
Nice-to-have
Scientific assessment and feasibility evaluation skills
Ability to foster collaborative cross-functional team environments
Experience driving process innovation and efficiency improvements
Strategic alignment with therapeutic area development goals
Key Requirements
B.A. or B.Sc. in a scientific discipline
6+ years in clinical operations management
Working knowledge of clinical trial phases I through IV