Clinical Trial Manager

Ocugen Opco Inc; Malvern (AR); On-site; USD 90,000 - 150,000; Full time

Job summary

Ocugen Opco Inc. is seeking a Clinical Trial Manager to lead the operational execution of multi-site studies from initiation to close-out.

You will oversee cross-functional teams, vendor relationships, budgets, and timelines to ensure high-quality data and regulatory compliance. This role requires a life sciences degree, 5+ years in clinical research, and 2+ years as a CTM, with experience in global Phase 1–3 trials and CRO oversight.

Qualifications

• Bachelor’s degree in life sciences or related field required.
• Minimum 5 years of clinical research experience in biotech/pharma.
• 2+ years in a Clinical Trial Manager role.
• Experience managing global Phase 1–3 trials and CRO oversight.
• Strong knowledge of ICH-GCP, FDA regulations.
• Proficiency with CTMS, eTMF, EDC; SAS a plus.

Responsibilities

• Lead planning, execution, and delivery of clinical studies per GCP/ICH.
• Own study operational plan aligned with protocol and program goals.
• Manage timelines, enrollment projections, budget tracking, and risk mitigation.
• Serve as primary contact for study vendors and oversee contracting and performance.
• Oversee internal and external clinical study teams across all trial sites and partners.
• Contribute to development/review of protocols, CRFs, ICFs, reports, and related documents.
• Lead site identification, qualification, initiation, and training activities; support Investigator Meetings.
• Ensure clinical systems (CTMS, eTMF, EDC) are used effectively and maintained.
• Review trial budgets and site expenses; collaborate with Finance for forecasts.
• Collaborate with QA to support audits and audit readiness; support regulatory submissions.
• Independently manage LDNA assessments at designated sites and oversee LDNA coordinators.
• Identify process improvements to enhance trial execution.
• Serve as a liaison between Clinical, Regulatory, QA, Finance, and external partners.
• Support clinical publications and scientific communications as needed.

Skills

Leadership

Cross-functional collaboration

Budget management

Vendor oversight

Regulatory compliance

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Tools

CTMS

eTMF

EDC

SAS

Job description

Position SummaryThe 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.ResponsibilitiesLead 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.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.Experience in ophthalmology and/or advanced therapy studies are strongly preferred.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.Working conditionsThis 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.