Senior Clinical Trial Operations Leader

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Wellness Programs

Vacation and holidays

401(k) plan

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen is seeking a Senior Manager, Clinical Trial Lead to spearhead planning, execution, and delivery of clinical studies across development. You will chair SMT, manage CROs, budgets, and timelines while aligning with GCP and regulatory standards for patient safety and data integrity.

You will collaborate with Medical, Biostatistics, Regulatory, and Data Management to optimize protocols and study strategies, driving operational excellence across programs.

Qualifications

• Bachelors degree in a scientific discipline required.
• 5+ years of clinical operations management experience in outsourced trials preferred.
• Strong project management, risk assessment, contingency planning, and communication skills.
• Experience across Phase I–IV trials and cross-functional development.
• Proven ability to manage CROs, vendors, budgets, quality, and outsourcing strategies.
• Knowledge of GCP, ICH, and global regulatory requirements for clinical development.

Responsibilities

• Lead the planning, execution, and delivery of one or more clinical studies.
• Chair the Study Management Team and drive cross-functional study execution.
• Partner with Medical, Biostatistics, Regulatory, and other stakeholders to develop operational protocols.
• Evaluate feasibility and develop operational, monitoring, quality, and risk plans.
• Manage study timelines, budgets, forecasts, and governance deliverables.
• Oversee CROs, vendors, and outsourced partnerships, ensuring performance and issue resolution.

Skills

Project management

Risk assessment

Cross-functional collaboration

Communication

GCP knowledge

ICH guidelines

Education

Bachelor's degree in a scientific discipline

Tools

CTMS

Job description

Biogen is seeking a Senior Manager, Clinical Trial Lead to spearhead planning, execution, and delivery of clinical studies across development. You will chair SMT, manage CROs, budgets, and timelines while aligning with GCP and regulatory standards for patient safety and data integrity.

You will collaborate with Medical, Biostatistics, Regulatory, and Data Management to optimize protocols and study strategies, driving operational excellence across programs.