Clinical Trial Operations Lead: Strategy & Delivery

Biogen, Inc.; 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

Paid holidays and personal days

Sick time

Parental Leave

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen, Inc. is seeking a Senior Manager, Clinical Trial Lead to own operational planning, execution, and delivery of complex clinical studies.

You will lead the SMT, coordinate with Medical, Biostatistics, Regulatory, and Data Management, and drive strategy that ensures timelines, budgets, and patient safety are upheld. The role requires deep experience in clinical operations, governance of CROs and vendors, and a strong track record of delivering trial milestones in compliance with GCP and

Qualifications

• Bachelor's degree in a scientific discipline.
• 6+ years in clinical operations management.
• Experience overseeing outsourced trials with adherence to timelines, budgets, and quality.
• GCP, ICH guidelines, and global regulatory requirements knowledge.
• Proven ability to develop operational plans and manage CRO/vendor partnerships.

Responsibilities

• Lead planning, execution, and delivery of one or more clinical studies.
• Chair the Study Management Team (SMT) and drive cross-functional study execution.
• Partner with Medical, Biostatistics, Regulatory, and other stakeholders to develop operationally feasible protocols and study strategies.
• Evaluate study feasibility and develop operational, monitoring, quality, and risk management plans.
• Manage study timelines, budgets, forecasts, and governance deliverables to ensure on-time, on-budget execution.
• Identify, assess, and mitigate operational risks while maintaining patient safety, data integrity, and regulatory compliance.
• Oversee CROs, vendors, and outsourced partnerships, ensuring performance, milestone achievement, and effective issue resolution.
• Monitor study performance and conduct ongoing data reviews to identify and address quality, safety, or execution issues.
• Maintain accurate, inspection-ready study documentation and data within clinical trial management systems.
• Champion process improvements, operational excellence, and best practices across studies and development programs.

Skills

Project management

Risk assessment

Contingency planning

Communication skills

GCP

ICH guidelines

Regulatory knowledge

Vendor management

Education

Bachelor's degree in a scientific discipline

Job description

Biogen, Inc. is seeking a Senior Manager, Clinical Trial Lead to own operational planning, execution, and delivery of complex clinical studies.

You will lead the SMT, coordinate with Medical, Biostatistics, Regulatory, and Data Management, and drive strategy that ensures timelines, budgets, and patient safety are upheld. The role requires deep experience in clinical operations, governance of CROs and vendors, and a strong track record of delivering trial milestones in compliance with GCP and