Remote Job
Clinical Project Manager
Cmed- Full Time
- Posted : 2 years ago
TELECOMMUTE Location: Remote, United States
Cmed is seeking an east or west coast remote based Clinical Project Manager. Role will invlove some travel and must have cosmetic clinical study expereience
The Clinical Project Manager plans and manages overall clinical operations for assigned global clinical trials/programs. This includes timelines, budgets, resources, investigational sites, vendors and key project deliverables. This position ensures compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and aligns with Strategic & Innovation Group (SIG) strategies and goals. The Senior CPM may lead or mentor other CPMs in the organization.
Responsibilities and Duties- Plan and Conduct Clinical Studies
- Lead and manage multidisciplinary Clinical Trial Teams to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices.
- Serve as the primary contact with CRO and act as team leader of the study work group.
- Manage Subcontractors
- Work with outsourcing manager to prepare clinical outsourcing specifications.
- Participate in the selection of CRO.
- Quality and Process
- Contribute to and initiate process improvement initiatives.
- Budget and Planning
- Establish project milestones, budget and timelines for the study in partnership with the study team and outsourcing manager.
- Project Team Representative (PTR)
- Participate in the overall project planning and optimization with the Project Team.
- Work closely with the Medical Experts and Clinical Scientist for the design of the clinical trials within the program.
- Other duties as assigned.
- Bachelor’s degree, preferably in a biologic/scientific discipline is required.
- Minimum of 5 years progressive experience in clinical operations including 3 years of clinical project management or equivalent with pharma, biotech and/or CRO is required.
- Systemic route of administration clinical trials experience required; pediatric, drug/device combination and biologics experience preferred.
- Thorough understanding of country-level regulations, ICH and GCP guidelines, cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.
- Vendor management experience preferred.
- Travel is estimated at 30%.
Skills
- Conversion Rate Optimization (CRO)
- Time management
- Data Management
- Project Management
- Vendor Management
- Partner Management
- Pharmaceutical
- Google Cloud Platform (GCP)
- Budget Management
