Clinical Trial Manager: Lead Global Studies & Ops

Ocugen Opco Inc; Malvern (AR); On-site; USD 90,000 - 150,000; Full time

Job summary

Ocugen Opco Inc. is seeking a Clinical Trial Manager to lead the operational execution of multi-site studies from initiation to close-out.

You will oversee cross-functional teams, vendor relationships, budgets, and timelines to ensure high-quality data and regulatory compliance. This role requires a life sciences degree, 5+ years in clinical research, and 2+ years as a CTM, with experience in global Phase 1–3 trials and CRO oversight.

Qualifications

• Bachelor’s degree in life sciences or related field required.
• Minimum 5 years of clinical research experience in biotech/pharma.
• 2+ years in a Clinical Trial Manager role.
• Experience managing global Phase 1–3 trials and CRO oversight.
• Strong knowledge of ICH-GCP, FDA regulations.
• Proficiency with CTMS, eTMF, EDC; SAS a plus.

Responsibilities

• Lead planning, execution, and delivery of clinical studies per GCP/ICH.
• Own study operational plan aligned with protocol and program goals.
• Manage timelines, enrollment projections, budget tracking, and risk mitigation.
• Serve as primary contact for study vendors and oversee contracting and performance.
• Oversee internal and external clinical study teams across all trial sites and partners.
• Contribute to development/review of protocols, CRFs, ICFs, reports, and related documents.
• Lead site identification, qualification, initiation, and training activities; support Investigator Meetings.
• Ensure clinical systems (CTMS, eTMF, EDC) are used effectively and maintained.
• Review trial budgets and site expenses; collaborate with Finance for forecasts.
• Collaborate with QA to support audits and audit readiness; support regulatory submissions.
• Independently manage LDNA assessments at designated sites and oversee LDNA coordinators.
• Identify process improvements to enhance trial execution.
• Serve as a liaison between Clinical, Regulatory, QA, Finance, and external partners.
• Support clinical publications and scientific communications as needed.

Skills

Leadership

Cross-functional collaboration

Budget management

Vendor oversight

Regulatory compliance

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Tools

CTMS

eTMF

EDC

SAS

Job description

Ocugen Opco Inc. is seeking a Clinical Trial Manager to lead the operational execution of multi-site studies from initiation to close-out.

You will oversee cross-functional teams, vendor relationships, budgets, and timelines to ensure high-quality data and regulatory compliance. This role requires a life sciences degree, 5+ years in clinical research, and 2+ years as a CTM, with experience in global Phase 1–3 trials and CRO oversight.