Senior Clinical Trial Leader: Drive Global Study Execution

OCUGEN OPCO INC; Malvern (Chester County); On-site; USD 120,000 - 180,000; Full time

Job summary

OCUGEN OPCO INC in Malvern, PA is seeking a Senior Clinical Trial Manager to lead the operational execution of clinical studies from initiation through close-out. You will drive study start-up, enrollment, timelines, and risk mitigation while coordinating across clinical operations, regulatory, biometrics, and external partners.

The role demands hands-on leadership in a fast-paced, resource-constrained environment, strong site engagement, vendor oversight, and ensuring inspection readiness of

Qualifications

• Bachelor’s degree required; advanced degree a plus.
• 7–10 years of clinical research experience.
• Experience managing study timelines, vendors, and operational risks.
• Strong knowledge of regulatory requirements (FDA, ICH-GCP).

Responsibilities

• Lead planning, execution and delivery of clinical studies per GCP/ICH and SOPs.
• Drive timelines, enrollment, and milestones to meet objectives.
• Oversee start-up activities including site activation and vendor coordination.
• Engage investigators and study physicians to drive progress.
• Manage CRO/vendor performance and ensure quality and timelines.
• Maintain inspection readiness of eTMF and other systems.

Skills

Program management

GCP/ICH compliance

Vendors & CRO oversight

Cross-functional collaboration

Communication skills

Risk management

Education

Bachelor’s degree in life sciences

Tools

CTMS

EDC

Veeva eTMF

Job description

OCUGEN OPCO INC in Malvern, PA is seeking a Senior Clinical Trial Manager to lead the operational execution of clinical studies from initiation through close-out. You will drive study start-up, enrollment, timelines, and risk mitigation while coordinating across clinical operations, regulatory, biometrics, and external partners.

The role demands hands-on leadership in a fast-paced, resource-constrained environment, strong site engagement, vendor oversight, and ensuring inspection readiness of