Senior Clinical Trial Manager

Position Summary

The Senior Clinical Trial Manager (Sr. CTM) is responsible for independently leading the operational management and execution of clinical trials from initiation through close-out. This role focuses on rigorous study execution, proactive risk identification, and strong coordination across clinical, regulatory, biometrics, and external partners.

The Sr. CTM leads complex or high-priority studies with minimal supervision, drives study start-up activities, and maintains strong engagement with investigators and study physicians. This role requires a hands-on, highly organized individual who is comfortable operating in a fast-changing, resource-constrained environment and who can drive execution through vendors, CROs, and internal teams.

Responsibilities

Clinical Execution and Delivery

• Independently lead the planning, execution, and delivery of clinical studies in accordance with GCP/ICH guidelines, SOPs, and regulatory requirements.
• Drive study timelines, enrollment execution, and operational milestones to meet program objectives.
• Anticipate operational risks and implement mitigation strategies to prevent delays or quality issues.
• Maintain clear visibility into timelines, dependencies, and critical paths across assigned studies.

Study Start-Up and Site Activation

• Lead or significantly contribute to study start-up activities including site feasibility, vendor coordination, regulatory package readiness, and site activation timelines.
• Support investigator selection, site qualification, and initiation activities to ensure efficient trial launch.

Physician and Investigator Engagement

• Build and maintain effective working relationships with investigators and study physicians.
• Support enrollment strategy, site performance, and investigator engagement to drive study progress.

Vendor and CRO Oversight

• Serve as the primary operational contact for CROs and vendors, ensuring performance, timelines, and quality expectations are met.
• Lead vendor governance discussions and hold vendors accountable for deliverables and issue resolution.

Systems, Documentation, and Inspection Readiness

• Oversee completeness, quality, and inspection readiness of the eTMF.
• Ensure timely filing and quality control of essential documents within Veeva eTMF and other clinical systems.
• Support audit and inspection readiness activities, ensuring documentation and operational processes meet regulatory expectations.

Cross-Functional Collaboration

• Partner closely with Clinical Development, Program Management, Biometrics, Regulatory, QA, and Finance to ensure studies remain aligned with program priorities and milestones.
• Facilitate clear communication and rapid resolution of operational challenges across functions.

Unblinded Study Responsibilities

• Serve in an unblinded operational role when required, maintaining strict confidentiality and protocol compliance.

Budget and Resource Discipline

• Collaborate with Finance and Clinical leadership to forecast and monitor study budgets.

Identify risks to timelines, resources, or costs early and implement corrective actions.

Travel

• Travel to investigator sites, meetings, and vendors as required to support study execution and oversight.

Continuous Improvement

• Identify and implement process improvements to enhance study execution, timelines, and operational efficiency.