Note: The job is a remote job and is open to candidates in USA. Advanced Recruiting Partners is seeking an experienced Clinical Project Manager (CPM) with a strong background in respiratory clinical research. The CPM will oversee the planning, execution, and management of clinical trials, ensuring projects are delivered on time and in compliance with regulations.
Responsibilities
- Lead the operational management of respiratory clinical trials from study start-up through closeout
- Serve as the primary liaison between sponsors, CROs, investigative sites, and internal teams
- Develop and maintain project timelines, study plans, and milestone tracking
- Monitor study progress and proactively identify and mitigate project risks
- Manage study budgets, timelines, and resource allocation
- Coordinate site activation, patient enrollment, monitoring activities, and database lock
- Ensure compliance with ICH-GCP guidelines, FDA regulations, protocol requirements, and company SOPs
- Oversee vendor relationships, including central laboratories, imaging vendors, and specialty service providers
- Facilitate sponsor meetings, project status updates, and cross-functional team meetings
- Review study metrics and prepare project reports for sponsors and leadership
- Support regulatory submissions and study documentation as needed
- Mentor and provide guidance to Clinical Research Coordinators, Clinical Research Associates, and project team members
Skills
- Bachelor's degree in Life Sciences, Nursing, Public Health, or a related field
- Minimum of 3–5 years of clinical project management experience
- Previous experience managing respiratory clinical trials (e.g., asthma, COPD, pulmonary fibrosis, cystic fibrosis, or other respiratory indications)
- Strong knowledge of ICH-GCP, FDA regulations, and clinical research processes
- Experience working with EDC, CTMS, eTMF, and other clinical trial management systems
- Excellent organizational, communication, and leadership skills
- Ability to manage multiple studies simultaneously in a fast-paced environment
- Strong problem-solving and decision-making abilities
- Project Management Professional (PMP) certification or equivalent
- Experience working with CROs and pharmaceutical or biotechnology sponsors
- Familiarity with pulmonary function testing (PFTs), spirometry, respiratory devices, and respiratory endpoints
- Experience managing multicenter clinical trials
- Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Associate (CCRA) certification preferred
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