Clinical Trials Manager

Synta Pharmaceuticals is looking for a highly motivated Clinical Trials Manager to join our growing development team. This individual will work with the Associate Director of Clinical Trials to oversee aspects of Synta's oncology studies, including the Phase 3, worldwide study of elesclomol in patients with metastatic melanoma.

Responsibilities:

Manage Synta's clinical programs to ensure that studies are conducted efficiently, on time, and within budget. Serve as the primary liaison between Synta and CROs in the running of outsourced clinical trial functions. Work with departmental members, as well as across functional groups, in the development and writing of clinical protocols. Work with departmental members, as well as across functional groups, in the development of study related documents (e.g., study synopses, CRFs, model informed consents). Generate monthly clinical project status report including patient recruitment and timeline progression. Select key study investigators; oversee site selection process. Chair clinical study team meetings. Work with Synta Outsourcing to negotiate both CRO and site contracts and budgets. Work with Program Management and finance to reconcile monthly actual and forecast budgets. Ensure cross-functional issues are resolved swiftly, successfully and creatively. Develop and maintain infrastructure to support the efficient conduct of clinical trials.

Qualifications:

Requires a BS, RN, or related degree and preferably 3-5 years as a CRA (oncology focus preferred). Demonstrated ability to apply GCPs, ICH and applicable National and International regulatory guidelines.