The Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. May 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).
May lead the Study team along with contributing 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.
A key focus will be the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and objectives set forth by the Study team.
4-5 years relevant experience Study Management Team Leader - Oncology is required with a BSc, 3 years with a MS/MPH, or 2 years with PharmD/PhD/MD Phase Ib/II/III Oncology trial experience strongly preferred Global trial experience strongly preferred Global Study Leadership of Pivotal NDA filing studies highly preferred PMP, CCRA certifications desired but not required.
Experience working in both sponsor and CRO organizations strongly preferred Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience
Orbis Data Solutions, a specialized clinical consulting and contract staffing firm, provides Biometric and Clinical Operations expertise to pharmaceutical, biotechnology and medical device companies nationwide.