Employer: Biogen
Location: South San Francisco, CA
Job Type: Full-time
Biogen’s West Coast Hub in South San Francisco is dedicated to developing targeted therapies for severe immune-mediated diseases. The company prioritizes scientific excellence, innovation, and patient impact through rapid drug development.
The Clinical Trial Manager is responsible for designing and overseeing clinical trial operations, including protocol development, operational strategy, and execution. This role involves close collaboration with CRO partners and cross-functional teams to ensure high-quality clinical research. The position is hybrid and requires regular travel to the South San Francisco office.
Develop and implement the study-level operational strategy to ensure efficient clinical trial execution.
Chair or co-chair Clinical Study Team (CST) meetings, providing guidance on study design and execution.
Manage CRO partnerships, ensuring high-quality execution in line with budgets and timelines.
Provide operational guidance to clinical trial sites and key suppliers.
Oversee regulatory documentation (eTMF) and study startup (e.g., site feasibility, selection, and regulatory packet distribution).
Monitor clinical study systems (IRT, EDC) and participate in system testing.
Ensure risk mitigation strategies are in place for study execution.
Ensure Good Clinical Practices (GCP), International Council for Harmonisation (ICH) guidelines, and regulatory compliance in all trial phases.
Support regulatory inspections and adherence to clinical development protocols.
Develop operational plans to support clinical trial execution under Global Clinical Operations (GCO) outsourcing models.
Oversee and manage clinical trial budgets, including invoice approvals and accrual processes.
Track trial costs, vendor contracts, and financial forecasting to ensure efficiency.
Work closely with CROs and vendors to optimize clinical trial execution.
A strategic and analytical thinker with a passion for clinical research and drug development.
Strong decision-making and leadership skills, capable of mentoring teams and driving operational success.
Adaptable to global clinical trial management, with a commitment to quality, efficiency, and compliance.
Bachelor’s degree in a scientific discipline with 7+ years of experience in life sciences.
5+ years of experience in clinical trial management overseeing outsourced trials.
Strong project management, risk assessment, and contingency planning skills.
Deep understanding of clinical development, including Phase I-IV trials.
Expertise in GCP, ICH guidelines, and regulatory requirements.
Experience in operational planning and CRO/vendor management.
Sponsor and/or CRO experience in global clinical trial management.
Investigator site and/or monitoring experience.
Base salary: $119,000 - $160,000 (based on skills, experience, and location).
Annual cash bonus and equity incentives.
Medical, Dental, Vision, & Life Insurance.
Fitness & Wellness Programs (including reimbursement).
Short- and Long-Term Disability Insurance.
Paid time off (vacation, holidays, sick leave, and parental leave).
401(k) program with company-matched contributions.
Tuition reimbursement (up to $10,000 per year).
Employee stock purchase plan.
Diversity & Inclusion (DE&I) programs and Employee Resource Groups (ERGs).
Be part of a leading biotechnology company driving cutting-edge research.
Work in an innovative and mission-driven environment.
Collaborate with top-tier talent in clinical research.
Enjoy career growth, mentorship, and leadership opportunities.
Biogen is an Equal Opportunity Employer and participates in E-Verify in the United States.
Advance your clinical trial management career with Biogen. Apply today!
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