Clinical Research Manager
RemoteUnited States
United StatesRemoteContractSmall
ContractSmall
Job Summary
Lead the planning, execution, and management of clinical trials across multiple therapeutic areas and phases, overseeing site selection, study start-up, patient recruitment, and close-out activities. Ensure compliance with FDA, ICH-GCP, and internal SOPs while managing cross-functional teams, vendors, and CROs. Supervise Clinical Research Associates and study coordinators, review study documentation, and track metrics for leadership. Oversee audits and regulatory inspections with up to 20% travel required. This remote role supports Pharmavise Consulting Corporation's network of Subject Matter Experts.
Required Qualifications
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field
- Minimum of 5–7 years of experience in clinical research
- 2+ years in a managerial or supervisory role
- In-depth knowledge of clinical trial processes
- In-depth knowledge of ICH-GCP guidelines
- In-depth knowledge of regulatory requirements
- Proven experience managing Phase I-IV trials
- Experience across multiple therapeutic areas
- Strong project management skills
- Strong leadership skills
- Strong team coordination skills
- Excellent written communication abilities
- Excellent verbal communication abilities
- Proficiency with clinical trial software (e.g., CTMS, EDC, eTMF platforms)
- Ability to travel up to 20% as needed
- Authorization to work in the U.S.
Desired Qualifications
- Master's degree
- Ph.D.
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