Senior Clinical Trial Manager

Senior Clinical Trial Manager

Main Corporate Office - Malvern, PA

Position Summary

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.

Responsibilities

Clinical Execution and Delivery

• 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.

Study Start-Up and Site Activation

• 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.

Physician and Investigator Engagement

• Build 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 Oversight

• 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.

Systems, Documentation, and Inspection Readiness

• 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.

Cross-Functional Collaboration

• 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.

Unblinded Study Responsibilities

• Serve in an unblinded operational role when required, maintaining strict confidentiality and protocol compliance.

Budget and Resource Discipline

• 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

• Travel to investigator sites, meetings, and vendors as required to support study execution and oversight.

Continuous Improvement

• Identify and implement process improvements to enhance study execution, timelines, and operational efficiency.

Qualifications

• 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.

Preferred

• 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.

Working Conditions

This 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, 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.