Senior Clinical Trial Leader: Drive Complex Study Execution

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

Job summary

Ocugen seeks a Senior Clinical Trial Manager to lead end-to-end clinical study execution from initiation through close-out, ensuring GCP/ICH compliance and proactive risk management. The role coordinates across clinical, regulatory, biometrics, and external partners to drive study milestones.

You will guide start-up, site activation, vendor oversight, and eTMF/documentation, mentor cross-functional teams, and maintain inspection readiness. Travel to sites and CROs is required.

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree 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 clinical trial regulations.
• Experience with clinical trial systems including CTMS, EDC, and eTMF.
• Experience with Veeva eTMF or comparable document management systems.
• Demonstrated ability to operate independently, prioritize effectively, and drive execution.
• Strong organizational, communication, and problem-solving skills.

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 visibility into timelines, dependencies, and critical paths across assigned studies.
• Lead or 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 for efficient trial launches.
• Build and maintain relationships with investigators and study physicians; support enrollment strategy and site performance.
• Serve as primary operational contact for CROs and vendors; lead governance discussions and ensure deliverables.

Skills

Organization

Communication

Problem solving

Education

Bachelor’s degree

Advanced degree

Tools

CTMS

EDC

eTMF

Veeva eTMF

Job description

Ocugen seeks a Senior Clinical Trial Manager to lead end-to-end clinical study execution from initiation through close-out, ensuring GCP/ICH compliance and proactive risk management. The role coordinates across clinical, regulatory, biometrics, and external partners to drive study milestones.

You will guide start-up, site activation, vendor oversight, and eTMF/documentation, mentor cross-functional teams, and maintain inspection readiness. Travel to sites and CROs is required.