Clinical Research Manager Jobs

Princeton, NJ

Fast growing clinical research organization seeks clinical research manager with at least 4 years of oncology study management experience.

Description -

-Manage interdisciplinary clinical research projects, as Project Manager, leading the clinical team to ensure on-time, on-budget performance
-Supervise, train, and mentor Clinical Research staff
-Approve investigator study budgets and contracts
- Review and approve regulatory and administrative documents from investigator sites
-Review and develop protocols?
- Review and approve Case Report Forms (CRFs)
-Plan, coordinate, and present at Investigators?? Meetings
-Participate in proposal meetings with potential clients
-Review Serious Adverse Event (SAE) reports?
- Review and approve monthly client invoices?
- Prepare project management reports for clients, project personnel, and management
-Review and approve monitoring trip reports
-Review Tables and Listings generated from study data
- Author Clinical Study Reports
-Train CRAs on monitoring, internal procedures, and query resolution
-Mentor Senior CRAs on project management procedures and policies

Requirements -

Bachelors Degree or RN - Must have at least 3-4 years of Oncology Study Mgmt experience
-For those with Bachelors Degree or RN, five years of experience in clinical research, data management, or regulatory affairs, with at least two years of experience in the monitoring and management of clinical research projects
-Ability and willingness to travel up to 20% of the time
-Excellent written and oral communication skills