Clinical Research Manager
P
Pharmavise Consulting CorporationLife Sciences
United StatesContractManager
Salary not disclosed
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Job Details
- Experience
- 5–7 years
- Required Skills
- Project Management
Requirements
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (Master’s or Ph.D. preferred).
- Minimum of 5–7 years of experience in clinical research, including 2+ years in a managerial or supervisory role.
- In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.
- Proven experience managing Phase I-IV trials across multiple therapeutic areas.
- Strong project management, leadership, and team coordination skills.
- Proficiency with clinical trial software (e.g., CTMS, EDC, eTMF platforms).
- Ability to travel up to 20% as needed.
Responsibilities
- Lead the planning, execution, and management of clinical trials across multiple therapeutic areas and phases.
- Oversee site selection, study start-up, patient recruitment, data collection, and close-out activities.
- Ensure compliance with FDA, ICH-GCP, and other applicable regulatory standards.
- Develop and maintain project timelines, budgets, and resource plans.
- Supervise and mentor Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), and study coordinators.
- Review and approve study documentation including protocols, CRFs, informed consent forms, and monitoring reports.
- Coordinate with cross-functional teams including regulatory affairs, data management, biostatistics, and medical writing.
- Manage vendor and CRO relationships, including contract negotiations and performance monitoring.
- Track and report on study metrics and provide regular updates to senior leadership.
- Oversee the preparation and conduct of audits and regulatory inspections.
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