Assoc. Dir/Sr. Manager Clinical Operations - Immuno-Oncology
Associate Director/Sr. Manager Clinical Operations, Immuno-oncology 1369410
Location: Cambridge, MA (Hybrid)
Therapeutic Area: Immuno-Oncology
Job Overview: Reporting to the VP, Clinical Development Operations, the successful candidate will be responsible for all aspects of clinical trial management for two global phase 1 oncology studies.
- Oversee the day-to-day operations of study execution, with a focus on site oversight from study startup to study closeout, patient enrollment, monitoring, compliance, and data flow and metrics from the clinical sites, CROs and vendors.
- Work with both internal teams and external vendors to oversee logistics in relation to the collection and shipment of biological samples which will be obtained for the purpose of executing the translational objectives of the clinical trials.
- Develop and maintain strong relationships with investigators, clinical site staff, and CROs/vendors globally.
- Contribute to or author key study documents including, but not limited to, protocols, informed consent forms, case report forms, study plans, laboratory and pharmacy manuals and clinical study reports.
- BS/BA/RN Degree in science or a health-related field is preferred
- Ideally 5+ years of experience in clinical study management. Sponsor experience is strongly preferred.
- Experience in executing clinical studies across various phases is desirable. Expertise in oncology drug development is preferred.
- Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
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