Senior Clinical Trial Manager

OCUGEN OPCO INC•East Whiteland Township, PA

3d•Onsite

About The Position

The Senior Clinical Trial Manager (Sr. CTM) is responsible for independently leading the operational management and execution of clinical trials from initiation through close-out. This role focuses on rigorous study execution, proactive risk identification, and strong coordination across clinical, regulatory, biometrics, and external partners. The Sr. CTM leads complex or high-priority studies with minimal supervision, drives study start-up activities, and maintains strong engagement with investigators and study physicians. This role requires a hands-on, highly organized individual who is comfortable operating in a fast-changing, resource-constrained environment and who can drive execution through vendors, CROs, and internal teams.

Requirements

Bachelor’s degree in life sciences or related field required; advanced degree a plus.
Minimum 7–10 years of clinical research experience in biotech or pharmaceutical settings, including experience managing clinical trials.
Demonstrated 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.
Experience supporting study start-up and site activation activities.
Demonstrated ability to operate independently, prioritize effectively, and drive execution in a fast-paced, changing environment.
Strong organizational, communication, and problem-solving skills.

Nice To Haves

Experience in ophthalmology, advanced therapies, or small to mid-size biotech companies.
Experience working in an unblinded study environment.
Experience engaging investigators and study physicians directly.

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 clear visibility into timelines, dependencies, and critical paths across assigned studies.
Lead or significantly 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 to ensure efficient trial launch.
Build and maintain effective working relationships with investigators and study physicians.
Support enrollment strategy, site performance, and investigator engagement to drive study progress.
Serve as the primary operational contact for CROs and vendors, ensuring performance, timelines, and quality expectations are met.
Lead vendor governance discussions and hold vendors accountable for deliverables and issue resolution.
Oversee completeness, quality, and inspection readiness of the eTMF.
Ensure timely filing and quality control of essential documents within Veeva eTMF and other clinical systems.
Support audit and inspection readiness activities, ensuring documentation and operational processes meet regulatory expectations.
Partner closely with Clinical Development, Program Management, Biometrics, Regulatory, QA, and Finance to ensure studies remain aligned with program priorities and milestones.
Facilitate clear communication and rapid resolution of operational challenges across functions.
Serve in an unblinded operational role when required, maintaining strict confidentiality and protocol compliance.
Collaborate with Finance and Clinical leadership to forecast and monitor study budgets.
Identify risks to timelines, resources, or costs early and implement corrective actions.
Travel to investigator sites, meetings, and vendors as required to support study execution and oversight.
Identify and implement process improvements to enhance study execution, timelines, and operational efficiency.