Senior Clinical Trial Lead: End-to-End Study Execution

Ocugen; Malvern (Chester County); On-site; USD 120,000 - 160,000; Full time

Job summary

Ocugen in Malvern, PA is seeking a Senior Clinical Trial Manager to lead operational management of clinical studies from initiation to close-out, ensuring GCP compliance and timely execution.

You will coordinate with investigators, CROs, and internal teams to drive startup, site activation, enrollment, and data integrity across programs. The role requires 7–10 years in biotech/pharma and strong ICH-GCP knowledge, with CTMS/EDC/eTMF experience (Veeva).

Qualifications

• Bachelor’s degree in life sciences; advanced degree a plus.
• 7–10 years in clinical research, biotech or pharmaceutical settings.
• Experience managing study timelines, vendors, and operational risks.
• Strong knowledge of ICH-GCP, FDA, and international regulations.
• Experience with CTMS, EDC, and eTMF systems (Veeva).
• Experience supporting study start-up and site activation activities.
• Ability to operate independently in a fast-paced, changing environment.
• Ophthalmology or advanced therapies experience preferred.

Responsibilities

• Independently lead planning, execution, and delivery of clinical studies per GCP/ICH and regulatory requirements.
• Drive study timelines, enrollment milestones, and operational deliverables.
• Anticipate risks and implement mitigation strategies to prevent delays or quality issues.
• Lead study startup activities including site feasibility, regulatory readiness, and site activation.
• Build relationships with investigators and study physicians to support progress.
• Oversee CROs and vendors, ensuring performance, timelines and quality.
• Ensure eTMF completeness and inspection readiness across systems (Veeva/eTMF).
• Collaborate across Clinical Development, Program Management, Biometrics, Regulatory, QA, and Finance.
• Travel to investigator sites and vendors as required to support execution.

Skills

Project management

Leadership

Cross-functional collaboration

GCP/ICH knowledge

Regulatory compliance

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred

Tools

CTMS

EDC

Veeva eTMF

Job description

Ocugen in Malvern, PA is seeking a Senior Clinical Trial Manager to lead operational management of clinical studies from initiation to close-out, ensuring GCP compliance and timely execution.

You will coordinate with investigators, CROs, and internal teams to drive startup, site activation, enrollment, and data integrity across programs. The role requires 7–10 years in biotech/pharma and strong ICH-GCP knowledge, with CTMS/EDC/eTMF experience (Veeva).