Clinical Trial Project Manager - Research Nurses
Core
Manage day-to-day operations of clinical trials for biotech and pharmaceutical companies, ensuring compliance with ICH/GCP regulations and serving as the primary sponsor contact for operational issues.
Role type
Senior Clinical Trial Project Manager (Research Nurse background)
Builds
Clinical development services for biotechnology, pharmaceutical, and medical device industries
Domain
Clinical Research / Biotechnology / Pharmaceuticals
Required skills
Clinical Research Nursing, Protocol Management, Vendor Management, Risk Assessment, Cross-functional Team Leadership, Study Quality Oversight, Regulatory Compliance (ICH/GCP), Therapeutic Area Knowledge
Preferred skills
Phases 2-3 Clinical Trial Experience, Research Nurse Experience
Technologies
Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Regulatory Reporting Tools
Responsibilities
Manage and provide accountability for day-to-day operations of the project according to ICH/GCP; Serve as primary Sponsor contact for operational project-specific issues; Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report; Develop operational project plans; Manage risk assessment and execution; Responsible for management of study vendor; Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables
Seniority
Senior, hands-on IC