Senior Clinical Trial Manager
Adlai Nortye · North Brunswick, NJ
FULL-TIME
Posted Sep 6, 2026
Job Description
Position Summary
A Clinical Trial Manager with 3-8 years of experience in the planning, execution, oversight, and delivery of clinical trials in accordance with protocol requirements, ICH-GCP guidelines, applicable regulations, and company SOPs. Manages study timelines, vendors, budgets, and cross-functional teams to ensure high-quality trial conduct and successful study outcomes.
Key Responsibilities
- Manage day-to-day operational aspects of Phase I–III clinical trials from study start-up through closeout.
- Develop and maintain study timelines, project plans, and trial tracking tools.
- Coordinate activities among CROs, clinical sites, vendors, and internal stakeholders.
- Monitor study progress and identify risks, implementing mitigation strategies as needed.
- Review and execute according to essential study documents, including protocols, informed consent forms, monitoring plans, and study manuals.
- Oversee CRO and site activation, enrollment, patient retention, and data collection activities.
- Ensure compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements.
- Have experience in managing study budgets, forecasts, and review of vendor contracts.
- Lead study team meetings and provide regular updates to senior management.
- Review monitoring reports, protocol deviations, and CAPA plans.
- Support regulatory submissions, ethics committee approvals, and inspection readiness activities as needed.
- Collaborate with Data Management, Biostatistics, Medical Monitoring, Safety, Regulatory Affairs, and Clinical Operations teams.
- Contribute to process improvements and implementation of best practices across clinical programs.
Qualifications
- Bachelor's degree in the Sciences, Nursing, Pharmacy, Public Health, or related field.
- Approximately 3-5 years of clinical research experience, including experience managing clinical studies.
- Strong understanding of ICH-GCP guidelines and clinical trial regulations.
- Experience working with CROs and external vendors.
- Knowledge of CTMS, EDC, eTMF, and clinical trial systems.
- Excellent project management, communication, and organizational skills.
- Ability to manage multiple priorities in a fast-paced environment.
Core Competencies
- Clinical Trial Management
- Project Planning & Execution
- Risk Management
- Vendor Oversight
- Budget Management
- Study Start-up & Closeout
- Site Management
- Regulatory Compliance
- Cross-functional Leadership
- Clinical Systems (CTMS, EDC, eTMF)
Typical Therapeutic Area Experience
- Oncology
Expected Scope at 5 Years Experience
- Independently manages 1–3 clinical studies or a significant portion of a large global study.
- Provides oversight of CRO activities and site performance.
- Escalates study risks appropriately and contributes to strategic study decisions.
- May mentor Clinical Trial Associates (CTAs) or junior Clinical Research Associates (CRAs).
A Clinical Trial Manager with 3-8 years of experience in the planning, execution, oversight, and delivery of clinical trials in accordance with protocol requirements, ICH-GCP guidelines, applicable regulations, and company SOPs. Manages study timelines, vendors, budgets, and cross-functional teams to ensure high-quality trial conduct and successful study outcomes.
Key Responsibilities
- Manage day-to-day operational aspects of Phase I–III clinical trials from study start-up through closeout.
- Develop and maintain study timelines, project plans, and trial tracking tools.
- Coordinate activities among CROs, clinical sites, vendors, and internal stakeholders.
- Monitor study progress and identify risks, implementing mitigation strategies as needed.
- Review and execute according to essential study documents, including protocols, informed consent forms, monitoring plans, and study manuals.
- Oversee CRO and site activation, enrollment, patient retention, and data collection activities.
- Ensure compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements.
- Have experience in managing study budgets, forecasts, and review of vendor contracts.
- Lead study team meetings and provide regular updates to senior management.
- Review monitoring reports, protocol deviations, and CAPA plans.
- Support regulatory submissions, ethics committee approvals, and inspection readiness activities as needed.
- Collaborate with Data Management, Biostatistics, Medical Monitoring, Safety, Regulatory Affairs, and Clinical Operations teams.
- Contribute to process improvements and implementation of best practices across clinical programs.
Qualifications
- Bachelor's degree in the Sciences, Nursing, Pharmacy, Public Health, or related field.
- Approximately 3-5 years of clinical research experience, including experience managing clinical studies.
- Strong understanding of ICH-GCP guidelines and clinical trial regulations.
- Experience working with CROs and external vendors.
- Knowledge of CTMS, EDC, eTMF, and clinical trial systems.
- Excellent project management, communication, and organizational skills.
- Ability to manage multiple priorities in a fast-paced environment.
Core Competencies
- Clinical Trial Management
- Project Planning & Execution
- Risk Management
- Vendor Oversight
- Budget Management
- Study Start-up & Closeout
- Site Management
- Regulatory Compliance
- Cross-functional Leadership
- Clinical Systems (CTMS, EDC, eTMF)
Typical Therapeutic Area Experience
- Oncology
Expected Scope at 5 Years Experience
- Independently manages 1–3 clinical studies or a significant portion of a large global study.
- Provides oversight of CRO activities and site performance.
- Escalates study risks appropriately and contributes to strategic study decisions.
- May mentor Clinical Trial Associates (CTAs) or junior Clinical Research Associates (CRAs).
Additional Details
- City
- North Brunswick
- State
- New Jersey
- Country
- US
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