Clinical Trial Manager
Ocugen
August 06, 2026
On-site
Malvern, PA
Clinical Research and Development
Responsibilities:
- Lead planning, execution, and delivery of clinical studies in accordance with GCP/ICH, 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.
- Serve as primary point of contact for study vendors (e.g., CROs, central labs, IRT, eCOA); oversee selection, scope, contracting, and performance.
- Oversee internal and external clinical study teams; ensure training, consistency, and accountability across trial sites.
- Contribute to development/review of protocols, amendments, CRFs, ICFs, and study reports (e.g., annual reports, IBs).
- Lead site identification, qualification, initiation, and training; support investigator meetings and site communications.
- Ensure clinical systems (CTMS, eTMF, EDC) are used effectively and maintained accurately.
- Review trial budgets and site expenses; provide approvals as appropriate.
- Collaborate with Finance (forecast/manage budgets) and Quality (audit readiness and audit plans).
- Support regulatory submissions and external safety board data reviews as applicable.
- Independently manage LDNA assessments at designated sites; oversee LDNA coordinator(s); maintain SOPs/manuals.
- Identify and implement process improvements to enhance clinical trial execution.
- Act as cross-functional liaison between Clinical, Regulatory, QA, Finance, and external partners.
- Contribute to clinical publications/scientific communications as needed.
- Perform additional projects as assigned.
Qualifications:
- Bachelor’s degree in life sciences or related field (advanced degree a plus).
- 5+ years clinical research experience in biotech/pharma; 2+ years as a Clinical Trial Manager.
- Experience managing global Phase 1–3 trials and vendor/CRO oversight.
- Ophthalmology and/or advanced therapy experience strongly preferred.
- Strong knowledge of ICH-GCP, FDA, and international clinical trial regulations.
- Ability to lead cross-functional teams, manage complex studies, and resolve operational challenges.
- Proficiency with CTMS, eTMF, EDC (SAS experience a plus).
- Excellent written/verbal communication; detail-oriented and organized.
- Self-directed, collaborative, and flexible in a fast-paced environment.
- Lead planning, execution, and delivery of clinical studies in accordance with GCP/ICH, 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.
- Serve as primary point of contact for study vendors (e.g., CROs, central labs, IRT, eCOA); oversee selection, scope, contracting, and performance.
- Oversee internal and external clinical study teams; ensure training, consistency, and accountability across trial sites.
- Contribute to development/review of protocols, amendments, CRFs, ICFs, and study reports (e.g., annual reports, IBs).
- Lead site identification, qualification, initiation, and training; support investigator meetings and site communications.
- Ensure clinical systems (CTMS, eTMF, EDC) are used effectively and maintained accurately.
- Review trial budgets and site expenses; provide approvals as appropriate.
- Collaborate with Finance (forecast/manage budgets) and Quality (audit readiness and audit plans).
- Support regulatory submissions and external safety board data reviews as applicable.
- Independently manage LDNA assessments at designated sites; oversee LDNA coordinator(s); maintain SOPs/manuals.
- Identify and implement process improvements to enhance clinical trial execution.
- Act as cross-functional liaison between Clinical, Regulatory, QA, Finance, and external partners.
- Contribute to clinical publications/scientific communications as needed.
- Perform additional projects as assigned.
Qualifications:
- Bachelor’s degree in life sciences or related field (advanced degree a plus).
- 5+ years clinical research experience in biotech/pharma; 2+ years as a Clinical Trial Manager.
- Experience managing global Phase 1–3 trials and vendor/CRO oversight.
- Ophthalmology and/or advanced therapy experience strongly preferred.
- Strong knowledge of ICH-GCP, FDA, and international clinical trial regulations.
- Ability to lead cross-functional teams, manage complex studies, and resolve operational challenges.
- Proficiency with CTMS, eTMF, EDC (SAS experience a plus).
- Excellent written/verbal communication; detail-oriented and organized.
- Self-directed, collaborative, and flexible in a fast-paced environment.