Senior Clinical Trial Manager

Ocugen Opco Inc; Malvern (AR); On-site; USD 90,000 - 140,000; Full time

Job summary

Ocugen Opco Inc. is seeking a Senior Clinical Trial Manager to independently lead the execution of complex clinical trials from initiation to close-out. The role emphasizes risk mitigation, study startup, and cross-functional collaboration with investigators, CROs, and internal teams.

The successful candidate will drive timelines, manage vendors, and ensure inspection readiness while operating in a dynamic, resource-constrained environment. Domestic and international travel may be required.

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree is 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 trial regulations.
• Experience with CTMS, EDC, and eTMF systems; Veeva eTMF experience preferred.

Responsibilities

• Independently lead planning, execution, and delivery of clinical studies per GCP/ICH.
• Drive study timelines, enrollment execution, and operational milestones.
• Lead study start-up activities including site feasibility, vendor coordination, and regulatory readiness.
• Engage investigators and study physicians to support enrollment and site performance.
• Oversee CROs and vendors; lead governance discussions and issue resolution.
• Ensure eTMF completeness, quality, and inspection readiness.
• Forecast and monitor budgets with Finance; identify risks early and take corrective actions.
• Travel to investigator sites and meetings as required.

Skills

Clinical trial management

Vendor & CRO management

Risk identification & mitigation

Project planning & timelines

Cross-functional collaboration

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

CTMS

EDC systems

eTMF systems (Veeva)

Job description

Position SummaryThe 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.ResponsibilitiesClinical Execution and DeliveryIndependently 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.Study Start-Up and Site ActivationLead 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.Physician and Investigator EngagementBuild and maintain effective working relationships with investigators and study physicians.Support enrollment strategy, site performance, and investigator engagement to drive study progress.Vendor and CRO OversightServe 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.Systems, Documentation, and Inspection ReadinessOversee 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.Cross-Functional CollaborationPartner 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.Unblinded Study ResponsibilitiesServe in an unblinded operational role when required, maintaining strict confidentiality and protocol compliance.Budget and Resource DisciplineCollaborate with Finance and Clinical leadership to forecast and monitor study budgets.Identify risks to timelines, resources, or costs early and implement corrective actions.TravelTravel to investigator sites, meetings, and vendors as required to support study execution and oversight.Continuous ImprovementIdentify and implement process improvements to enhance study execution, timelines, and operational efficiency.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.PreferredExperience 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.Working ConditionsThis position operates in an office setting when not traveling on business. Domestic and international travel may be required.Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.