Clinical Study Manager
Clinical Study Manager needs 5 years relevant experience is required with a BSc, 3 years with a MS/MPH, or 2 years with PharmD/PhD/MD
Clinical Study Manager requires:
- Phase II/III Oncology trial experience strongly preferred
- Global trial experience strongly preferred
- Experience working in both sponsor and CRO organizations strongly preferred
- Candidates with a nursing diploma/assoc degree with substantial experience may be considered for this position.
- clinical
or basic research in a Pharmaceutical company, a Medical
device/Diagnostic company, Academic Research Organization (ARO) or
Contract Research Organization (CRO). CRA experience is preferred. Time
spent directly in a medical environment (e.g. as a Study Site
Coordinator) is also considered relevant.
Clinical Study Manager duties are:
- Develop
project cross-functional, integrated study plan to study start up
(in-house) and validate and manage to the overall study implementation
plan provided by the CRO. Participate in site selection and site
qualification with (study team and CRO). - Contribute to
operational delivery aspects of the protocol and lead document review
& coordination for the protocol and amendments. - Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.
$57/hr
6 months