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Clinical Study Manager

Clinical Study Manager needs 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

Clinical Study Manager requires:

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 is preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevan

Clinical Study Manager duties:

Work closely and oversee CRO activities for study execution with CRO on a task / operational level per the project plan.
Oversee CRF completion and monitoring; Triage, resolve or escalate study issues to the supervisor.
responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.

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