-
Manage interdisciplinary clincical 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 develop protocols
-
Review and approve Case Reports 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 internal 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
Job Qualifications:
-
Bachelor’s degrees required; MS, MPH, PharmaD, PhD, or other advanced life science degree preferred.
-
Five years of experience in clinical research, data management, or regulatory affairs, with at least 2 years of experience in the monitoring and management of clinical research project
-
Ability and willingness to travel up to 20% of the time
-
Excellent written and oral communication skill