Senior Clinical Trial Operations Lead

Regulatory Jobs; Cambridge (MA); On-site; USD 141,000 - 188,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Short- and Long-Term Disability

Paid vacation and year-end shutdown

Holidays + personal days

Sick time

Parental Leave

401(k) matching

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen in Cambridge, MA leads complex clinical operations and partners with Medical, Biostatistics, and Regulatory to deliver trials that meet quality and safety standards. The Senior Manager, Clinical Trial Lead shapes study execution, risk management, and vendor governance across development programs.

The role emphasizes cross-functional collaboration, patient safety, and data integrity while driving operational excellence and on-time study delivery in a fast-paced environment.

Qualifications

• 6+ years in clinical operations management with outsourced trials.
• Experience leading Study Management Team and CRO/vendor oversight.
• Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.
• Ability to develop operational plans and manage budgets.

Responsibilities

• Lead planning, execution, and delivery of one or more clinical studies.
• Chair the SMT and drive cross-functional study execution.
• Collaborate with Medical, Biostatistics, Regulatory to develop protocols.
• Develop operational, monitoring, quality, and risk plans.
• Manage study timelines, budgets, forecasts, and governance.
• Mitigate operational risks; ensure patient safety and data integrity.
• Oversee CROs and vendors; ensure performance and milestones.
• Monitor study performance and conduct data reviews.
• Maintain inspection-ready study documentation in CTMS.
• Champion process improvements and operational excellence.

Skills

Project management

Risk assessment

Contingency planning

Communication skills

GCP compliance

Clinical operations leadership

Education

Bachelor's degree in a scientific discipline

Job description

Biogen in Cambridge, MA leads complex clinical operations and partners with Medical, Biostatistics, and Regulatory to deliver trials that meet quality and safety standards. The Senior Manager, Clinical Trial Lead shapes study execution, risk management, and vendor governance across development programs.

The role emphasizes cross-functional collaboration, patient safety, and data integrity while driving operational excellence and on-time study delivery in a fast-paced environment.