Senior Clinical Trials Operations Leader

Biogen; North Carolina; Híbrido; USD 141.000 - 188.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision, & Life ins.

401(k) program with company match

Tuition reimbursement

Descripción de la vacante

Biogen seeks a Senior Manager, Clinical Trial Lead to oversee the operational planning, execution, and delivery of one or more clinical studies across development. You will lead the SMT, manage budgets, timelines, and CRO partnerships, ensuring patient safety, data integrity, and GCP compliance.

You will collaborate with Medical, Biostatistics, Regulatory, and Data Management to optimize protocols and study strategies, driving operational excellence and proactive issue resolution in a fast-paced

Formación

• Bachelor's degree in a scientific discipline.
• 6+ years in clinical operations management overseeing outsourced trials.
• Strong project management, risk assessment, contingency planning, and communication skills.
• Working knowledge of GCP, ICH guidelines, and global regulatory requirements.
• Experience managing CROs, vendors, and outsourcing strategies.

Responsabilidades

• 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, 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.

Conocimientos

Bachelors degree

Clinical ops

Project management

GCP/ICH knowledge

CRO management

Regulatory knowledge

Operational planning

Educación

Bachelor's degree

Descripción del empleo

Biogen seeks a Senior Manager, Clinical Trial Lead to oversee the operational planning, execution, and delivery of one or more clinical studies across development. You will lead the SMT, manage budgets, timelines, and CRO partnerships, ensuring patient safety, data integrity, and GCP compliance.

You will collaborate with Medical, Biostatistics, Regulatory, and Data Management to optimize protocols and study strategies, driving operational excellence and proactive issue resolution in a fast-paced