: Clinical Project ManagerTYPE
: Direct HireLOCATION
: King of Prussia, PASTART DATE
: August 2021
Our client, located near King of Prussia, PA, is looking to hire a Clinical Project Manager for a full-time opportunity. This person will be primarily responsible for ensuring all clinical programs follow SOP, Regulatory regulations, local/federal laws, and all the standards governing the clinical studies. This person will also manage the risk, supplier control, and SOP per study. Main Responsibilities
- Develop and maintain the clinical risk management program. This includes creating Key Risk Indicators for clinical and validation studies, vendor selection, and site/system integrations.
- Coordination of team selection and meetings to ensure project schedules are kept.
- Responsible for the vendor management program and clinical site maintenance by conducting audits and risk assessments.
- Manage CAPAS and departmental data using Quality Management System (QMS).
- Working with CRA and SADS for database design, rules, and validation.
- Providing support to the team with data entry, query generation, EDT, and CRF tracking.
- Follow GCP protocols for data management.
- 4-year college degree required with 2 years of experience working ins clinical research, clinical laboratory, or FDA regulated environment.
- Extensive knowledge of GCP, FDA regulations, and Data Management.
- Excellent communication skills, both written and verbal.
- Ability to work in a fast-paced, deadline-oriented environment.
- Risk Analysis
- Clinical Research
- Clinical Research Associate
- Good Clinical Practices (Gcp)