Senior Clinical Trial Manager

About the role

The Senior Clinical Trial Manager (Sr. CTM) independently leads the operational management and execution of clinical trials from initiation through close-out, focusing on rigorous study execution, proactive risk identification, and strong coordination across clinical, regulatory, biometrics, and external partners. This role leads complex or high-priority studies with minimal supervision, drives study start-up activities, and maintains strong engagement with investigators and study physicians.

Responsibilities

• 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.
• 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.
• Build and maintain effective working relationships with investigators and study physicians.
• Support enrollment strategy, site performance, and investigator engagement to drive study progress.
• 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.
• 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.
• 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.
• Serve in an unblinded operational role when required, maintaining strict confidentiality and protocol compliance.
• 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 to investigator sites, meetings, and vendors as required to support study execution and oversight.
• Identify and implement process improvements to enhance study execution, timelines, and operational efficiency.

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree a plus.
• Minimum 7–10 years of clinical research experience in biotech or pharmaceutical settings, including experience managing clinical trials.
• Demonstrated experience managing study timelines, vendors, and operational risks.
• Strong knowledge of ICH-GCP, FDA, and international clinical trial regulations.
• Experience with clinical trial systems including CTMS, EDC, and eTMF.
• Experience with Veeva eTMF or comparable document management systems.
• Experience supporting study start-up and site activation activities.
• Demonstrated ability to operate independently, prioritize effectively, and drive execution in a fast-paced, changing environment.
• Strong organizational, communication, and problem-solving skills.

Preferred Qualifications

• Experience in ophthalmology, advanced therapies, or small to mid-size biotech companies.
• Experience working in an unblinded study environment.
• Experience engaging investigators and study physicians directly.

Working Conditions

This position operates in an office setting when not traveling on business. Domestic and international travel may be required.