Senior Manager, Clinical Operations

Job Description Summary

The Senior Manager, Clinical Operations is responsible for the operational planning, execution, and oversight of clinical trials supporting the company's clinical development programs. This role may serve as the Lead Clinical Trial Manager or function as a key operational contributor within a larger program team. The position ensures clinical trials are conducted in compliance with applicable regulatory requirements, ICH-GCP guidelines, company Standard Operating Procedures (SOPs), and study protocol. The Senior Manager collaborates cross-functionally with internal and external stakeholders and external service providers to ensure the successful delivery of clinical trials with respect to quality, timelines, and budget. The Senior Manager may have direct reports, and will provide leadership, mentorship, and operational guidance to junior team members.

Essential Functions

Clinical Trial Management

• Lead or support the operational execution of Phase I-IV clinical trials, depending on study complexity and program needs.
• Serve as Lead Clinical Trial Manager for assigned studies, with responsibility for study timelines, operational strategy, and study deliverables.
• Contribute to the development planning and operational feasibility assessments.
• Develop and manage key study documents including Clinical Trial Management Plans, study timelines and milestone tracking, vendor scopes of work and operational budgets.
• Oversee study start-up, conduct, and close-out activities.

Clinical CRO and Service Provider Oversight

• Provide operational oversight of Clinical CROs and other operational service providers to ensure delivery of services consistent with contracted agreements and study requirements.
• Participate in service provider selection, RFP development, and contract review.
• Monitor service provider performance, study metrics, and key performance indicators to ensure study quality and timelines are maintained.

Cross-Functional Collaboration

• Partners with internal functions including Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Medical Writing, Project Management, Clinical Supply, and Quality Assurance.
• Ensure alignment of operational study and overall program strategy and development timelines.

Study Oversight and Compliance

• Ensure clinical trials are conducted in accordance with ICH-GCP guidelines, applicable global regulatory requirements, and company policies and standard operating procedures.
• Support inspection readiness and contribute to audit preparations and follow-up activities.
• Identify operational risks and develop mitigation and contingency strategies.

Site and Study Support

• Provide oversight of site identification, feasibility, selection, and activation activities.
• Review monitoring reports and key study metrics to ensure appropriate study oversight.
• Support resolution of site issues, enrollment challenges, and protocol implementation questions.

Budget and Timeline Management

• Contribute to study budget development and ongoing financial oversight.
• Monitor study progress against timelines, key milestones, and performance metrics.
• Identify potential risks to study execution and implement corrective actions as needed.

Team Leadership and People Management

• May manage and develop direct reports.
• Provide mentorship, guidance, and oversight of junior Clinical Operations staff.
• Support performance management, professional development, and training of team members.
• Foster a collaborative and high-performing clinical operations team environment.

Documentation and Reporting

• Contributes to preparation of study management plans, service provider oversight documentation, and operational reports.
• Provides regular updates on study status, risks, and mitigation strategies to Clinical Operations Leadership.
• Ensure study documentation is maintained in accordance with company requirements and is inspection ready.