Clinical Trial Operations Leader

NCBioImpact; Durham (NC); On-site; USD 141,000 - 188,000; Full time

Benefits offered by this job

Medical, Dental, Vision, Life ins.

Fitness & Wellness programs

Paid vacation and holidays

401(k) matching

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen seeks a Senior Manager, Clinical Trial Lead to oversee one or more clinical studies across the development lifecycle, coordinating timelines, budgets, CROs, and cross-functional teams to ensure patient safety, data integrity, and regulatory compliance.

You will partner with Medical, Biostatistics, Regulatory, and Data Management to drive feasible protocols and proactive issue management, delivering studies on time and within budget.

Qualifications

• Bachelor's degree in a scientific discipline.
• 6+ years in clinical operations management with outsourced trials.
• Strong project management, risk assessment, contingency planning, and communication skills.
• Working knowledge of clinical development across Phase I–IV.
• Experience managing CROs, vendors, and outsourcing strategies.
• GCP, ICH guidelines, and global regulatory requirements expertise.
• Proven ability to develop and execute operational plans for trial delivery.

Responsibilities

• Lead the operational 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 comprehensive 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 and milestone achievement.
• Monitor study performance and conduct ongoing data reviews to address quality, safety, or execution issues.
• Maintain accurate, inspection-ready study documentation and data in trial management systems.
• Champion process improvements and best practices across studies and programs.

Skills

Science degree

Clinical ops mgmt

Project management

Risk assessment

GCP/ICH knowledge

Regulatory knowledge

Vendor management

Cross-functional collaboration

Drug development knowledge

Communication

Education

Science degree

Tools

Job description

Biogen seeks a Senior Manager, Clinical Trial Lead to oversee one or more clinical studies across the development lifecycle, coordinating timelines, budgets, CROs, and cross-functional teams to ensure patient safety, data integrity, and regulatory compliance.

You will partner with Medical, Biostatistics, Regulatory, and Data Management to drive feasible protocols and proactive issue management, delivering studies on time and within budget.