Senior Clinical Trial Manager: Lead End-to-End Studies

Ocugen Opco Inc; Malvern (AR); On-site; USD 90,000 - 140,000; Full time

Job summary

Ocugen Opco Inc. is seeking a Senior Clinical Trial Manager to independently lead the execution of complex clinical trials from initiation to close-out. The role emphasizes risk mitigation, study startup, and cross-functional collaboration with investigators, CROs, and internal teams.

The successful candidate will drive timelines, manage vendors, and ensure inspection readiness while operating in a dynamic, resource-constrained environment. Domestic and international travel may be required.

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree is a plus.
• 7–10 years of clinical research experience in biotech or pharmaceutical settings.
• Experience managing study timelines, vendors, and operational risks.
• Strong knowledge of ICH-GCP, FDA, and international trial regulations.
• Experience with CTMS, EDC, and eTMF systems; Veeva eTMF experience preferred.

Responsibilities

• Independently lead planning, execution, and delivery of clinical studies per GCP/ICH.
• Drive study timelines, enrollment execution, and operational milestones.
• Lead study start-up activities including site feasibility, vendor coordination, and regulatory readiness.
• Engage investigators and study physicians to support enrollment and site performance.
• Oversee CROs and vendors; lead governance discussions and issue resolution.
• Ensure eTMF completeness, quality, and inspection readiness.
• Forecast and monitor budgets with Finance; identify risks early and take corrective actions.
• Travel to investigator sites and meetings as required.

Skills

Clinical trial management

Vendor & CRO management

Risk identification & mitigation

Project planning & timelines

Cross-functional collaboration

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

CTMS

EDC systems

eTMF systems (Veeva)

Job description

Ocugen Opco Inc. is seeking a Senior Clinical Trial Manager to independently lead the execution of complex clinical trials from initiation to close-out. The role emphasizes risk mitigation, study startup, and cross-functional collaboration with investigators, CROs, and internal teams.

The successful candidate will drive timelines, manage vendors, and ensure inspection readiness while operating in a dynamic, resource-constrained environment. Domestic and international travel may be required.