Sr. Clinical Trial Manager

About Ocugen Netherlands B.V.

Ocugen Netherlands B.V. is the European subsidiary of Ocugen, Inc., a U.S.-based biotechnology company focused on developing innovative gene and cell therapies and vaccines to improve patients lives. Our work includes advancing novel treatments for serious retinal diseases with significant unmet medical needs.

We are establishing our European operations in Amsterdam to support clinical development, regulatory activities, and future commercialization. Joining our growing team offers the opportunity to help build our European presence, collaborate with colleagues across the United States and internationally, and contribute to bringing potentially transformative therapies to patients.

This position is based onsite at our Amsterdam office, with in-office attendance expected.

Position Summary

The Sr. Clinical Trial Manager (CTM) is responsible for the operational planning, management, and delivery of assigned clinical trials from initiation through closeout. Based in Amsterdam, the Sr. CTM will oversee European study execution while collaborating closely with Ocugens US-based Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, Quality, and other functions.

The Sr. CTM will lead cross-functional study activities, oversee CRO and vendor performance, manage timelines and budgets, and ensure high-quality data, regulatory compliance, and inspection readiness. This is a hands-on role requiring strong operational leadership and the ability to establish structure, identify risks early, and maintain accountability across internal and external partners in a lean, rapidly growing European organization.

Responsibilities

- Lead the planning, execution, and delivery of assigned Phase 1–3 clinical trials in accordance with the protocol, Ocugen procedures, ICH Good Clinical Practice, the EU Clinical Trials Regulation, and other applicable requirements.

- Own the clinical study operational plan and ensure alignment with the scientific protocol, global development strategy, and program objectives.

- Manage study timelines, enrollment projections, operational deliverables, budgets, risks, dependencies, and mitigation plans.

- Lead cross-functional study-team meetings, establish clear ownership and deadlines, document decisions, and ensure timely resolution or escalation of issues.

- Serve as the primary operational contact for CROs and other study vendors, including central laboratories, imaging providers, IRT, eCOA, and specialty service providers.

- Oversee CRO and vendor selection, scope development, contracting support, study start-up, governance, performance management, issue resolution, and closeout.

- Establish meaningful CRO, vendor, country, and site performance measures and hold external partners accountable for quality, timelines, and contractual deliverables.

- Oversee European countries and site start-up, including feasibility, site selection, activation, ethics and regulatory dependencies, recruitment planning, and readiness to enroll participants.

- Oversee investigational-site performance, enrollment, monitoring activities, protocol compliance, data quality, and closure of findings and action items.

- Ensure that CTMS, eTMF, EDC, and other clinical systems are accurate, complete, and maintained in an inspection-ready state.

- Partner with Regulatory Affairs to support EU clinical trial applications and submissions through CTIS and ensure operational compliance with applicable national requirements.

- Contribute to the development and review of protocols, amendments, informed consent forms, case report forms, investigator brochures, clinical study reports, study plans, regulatory documents, and other key materials.

- Work with Finance and external partners to develop, forecast, track, and reconcile study budgets, investigator payments, change orders, and vendor expenses.

- Partner with Quality to maintain audit and inspection readiness, support audit planning and execution, and ensure timely remediation of observations and quality issues.

- Ensure risks affecting participant safety, data integrity, enrollment, timelines, budget, or submission readiness are identified early and communicated with clear recommendations.

- Support data review, database-cleaning activities, interim analyses, safety-review committees, and database lock, as applicable.

- Support clinical and regulatory activities necessary for late-stage development, registration, and future MAA submissions.

- Identify and implement process improvements that strengthen study execution, CRO governance, documentation quality, and European Clinical Operations capabilities.

- Maintain effective communication and alignment among European operations, US- based functions, investigational sites, and external partners.

- Perform other responsibilities consistent with the position and evolving business needs.

Qualifications

- Bachelor’s degree in life sciences or a related discipline required; advanced degree preferred.

- At least 5-8 years of clinical research experience in the biotechnology or pharmaceutical industry, including at least 3-5 years in a Clinical Trial Manager or comparable study-management role.

- Demonstrated experience managing Phase 2 or Phase 3 clinical trials, preferably within a global development program.

- Significant experience overseeing CROs, clinical vendors, investigational sites, timelines, study budgets, and cross-functional deliverables.

- Working knowledge of ICH E6(R3) GCP, the EU Clinical Trials Regulation, CTIS, GDPR, and applicable European clinical-trial requirements.

- Experience with European country and site start-up, trial execution, and inspection-readiness activities.

- Demonstrated ability to lead cross-functional teams, manage complex studies, resolve operational challenges, and influence stakeholders without direct authority.

- Experience with clinical trial systems, including CTMS, eTMF, and EDC; Veeva experience preferred.

- Experience in ophthalmology, gene therapy, advanced therapies, or rare-disease clinical development strongly preferred.

- Experience supporting late-stage development, registration-enabling studies, or marketing-authorization activities preferred.

- Strong financial and analytical skills, including experience managing forecasts, vendor budgets, change orders, and study expenses.

- Excellent written and verbal communication skills in English. Additional European language capabilities are an advantage.

- Self-directed, collaborative, highly organized, and comfortable working in a fast-paced environment with evolving infrastructure and priorities.

- Ability to travel within Europe and internationally, as required.

Working Conditions

This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

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.