Clinical Trial Manager

OCUGEN OPCO INC•East Whiteland Township, PA

5d•Onsite

About The Position

The Clinical Trial Manager (CTM) is responsible for the overall operational management and execution of clinical trials from initiation through close-out. This includes leading the cross-functional study team, managing vendor and site performance, maintaining budget and timelines, and ensuring high-quality data and regulatory compliance. The CTM plays a critical role in driving studies aligned with Ocugen’s development and business strategies.

Requirements

Bachelor’s degree in life sciences or related field required; advanced degree a plus.
Minimum 5 years of clinical research experience in biotech/pharma, including 2+ years in a Clinical Trial Manager role.
Experience managing global Phase 1–3 trials and vendor/CRO oversight required.
Strong knowledge of ICH-GCP, FDA, and international clinical trial regulations.
Demonstrated ability to lead cross-functional teams, manage complex studies, and resolve operational challenges.
Proficiency with clinical trial systems (e.g., CTMS, eTMF, EDC); experience with SAS a plus.
Excellent written and verbal communication skills; detail-oriented with strong organizational capabilities.
Self-directed, collaborative, and flexible in a fast-paced environment.

Nice To Haves

Experience in ophthalmology and/or advanced therapy studies are strongly preferred.

Responsibilities

Lead the planning, execution, and delivery of clinical studies in accordance with GCP/ICH guidelines, SOPs, and regulatory requirements.
Own the study operational plan and ensure alignment with the scientific protocol and program goals.
Manage clinical timelines, enrollment projections, budget tracking, and risk mitigation strategies.
Serve as the primary point of contact for study vendors (e.g., CROs, central labs, IRT, eCOA) and oversee vendor selection, scope development, contracting, and performance management.
Oversee internal and external clinical study teams, ensuring training, consistency, and accountability across all trial sites and partners.
Contribute to the development and review of protocols, amendments, CRFs, ICFs, study reports, and other key documents (e.g., annual reports, IBs).
Lead site identification, qualification, initiation, and training activities; support Investigator Meetings and site communications.
Ensure clinical systems (e.g., CTMS, eTMF, EDC) are used effectively and accurately maintained.
Review proposed trial budgets and site-related expenses, providing approvals as appropriate.
Collaborate with Finance to forecast and manage study budgets and with Quality to support audit readiness and execution of audit plans.
Support regulatory submissions and external safety board data reviews as applicable.
Independently manage LDNA assessments at designated sites and oversee the LDNA coordinator(s); maintain associated SOPs and manuals.
Identify and implement process improvements to enhance clinical trial execution.
Serve as a cross-functional liaison between Clinical, Regulatory, QA, Finance, and external partners to ensure execution aligns with company priorities.
Contribute to the development of clinical publications and scientific communications as needed.
Perform additional projects and responsibilities as assigned.