Clinical Trial Manager

Initial Therapeutics, Inc.; Malvern (Chester County); On-site; USD 120,000 - 180,000; Full time

Job summary

Ocugen seeks a Clinical Trial Manager to lead end-to-end execution of multiple trials from initiation through close-out in a fast-paced biotech environment.

You will manage cross-functional study teams, vendors, budgets, timelines, and data quality while ensuring GCP compliance and regulator readiness.

Office-based in Malvern, PA with potential for flex hours as needed; strong communication and problem-solving skills are essential.

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree a plus.
• Minimum 5 years of clinical research experience; 2+ years in CTM role.
• Experience managing global Phase 1-3 trials with vendor oversight.
• Strong knowledge of ICH-GCP, FDA regulations and international guidance.
• Proven ability to lead cross-functional teams and manage complex studies.

Responsibilities

• Lead planning, execution, and delivery of studies per GCP/ICH and SOPs.
• Own study operational plan aligned with protocol and program goals.
• Manage timelines, enrollment, budget tracking, and risk mitigation.
• Oversee vendors (CROs, labs, IRT, eCOA) and contract performance.
• Coordinate training and accountability across trial sites and partners.
• Support protocol amendments, ICFS, study reports and publications.
• Lead site identification, qualification, initiation, and training.
• Ensure CTMS/eTMF/EDC are kept accurate and up to date.
• Review budgets and site expenses; collaborate with Finance and QA.
• Support regulatory submissions and safety reviews; LDNA oversight.

Skills

Clinical trial execution

Cross-functional leadership

Regulatory compliance

Vendor/CRO oversight

Timeline & budget management

Study team coordination

I CH-GCP knowledge

Communication skills

Problem-solving

Education

Bachelor’s in life sciences or related field

Advanced degree

Tools

CTMS

eTMF

EDC

SAS (a plus)

Job description

Description

Position Summary

The 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.

Responsibilities

• Lead 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.

Qualifications

• 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 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.