Clinical Trial Manager

Position Summary

The Clinical Trial Manager (CTM) is responsible for the overall operational management and execution of clinical trials from initiation through close-out. This includes leading the cross-functional study team, managing vendor and site performance, maintaining budget and timelines, and ensuring high-quality data and regulatory compliance. The CTM plays a critical role in driving studies aligned with Ocugen’s development and business strategies.

Responsibilities

• Lead the planning, execution, and delivery of clinical studies in accordance with GCP/ICH guidelines, SOPs, and regulatory requirements.
• Own the study operational plan and ensure alignment with the scientific protocol and program goals.
• Manage clinical timelines, enrollment projections, budget tracking, and risk mitigation strategies.
• Serve as the primary point of contact for study vendors (e.g., CROs, central labs, IRT, eCOA) and oversee vendor selection, scope development, contracting, and performance management.
• Oversee internal and external clinical study teams, ensuring training, consistency, and accountability across all trial sites and partners.
• Contribute to the development and review of protocols, amendments, CRFs, ICFs, study reports, and other key documents (e.g., annual reports, IBs).
• Lead site identification, qualification, initiation, and training activities; support Investigator Meetings and site communications.
• Ensure clinical systems (e.g., CTMS, eTMF, EDC) are used effectively and accurately maintained.
• Review proposed trial budgets and site-related expenses, providing approvals as appropriate.
• Collaborate with Finance to forecast and manage study budgets and with Quality to support audit readiness and execution of audit plans.
• Support regulatory submissions and external safety board data reviews as applicable.
• Independently manage LDNA assessments at designated sites and oversee the LDNA coordinator(s); maintain associated SOPs and manuals.
• Identify and implement process improvements to enhance clinical trial execution.
• Serve as a cross-functional liaison between Clinical, Regulatory, QA, Finance, and external partners to ensure execution aligns with company priorities.
• Contribute to the development of clinical publications and scientific communications as needed.
• Perform additional projects and responsibilities as assigned.