Senior Clinical Study Manager
A global pharmaceutical corporation specializing in the Oncology space is seeking to hire a Clinical Study Manager to ensure the delivery execution of clinical studies in one or more geographic regions. This individual will be reported into the Associate Director responsible for Operational Study Strategy.
The Senior Clinical Study Manager will be responsible for: 1) 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. 2) Participate in site selection and site qualification with study team and CRO. 3) Contribute to operational delivery aspects of the protocol and lead document review & coordination for the protocol and amendments. 4) Medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. 5) Act as the project manager of the clinical study team to liaise and coordinate with internal stakeholders to ensure cross functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc.) per the study plan.
Location: Basking Ridge, New Jersey
Compensation: Negotiable (per hour rate-contract)
- Education: Bachelor's degree in the Sciences, with a nursing diploma/Associate's degree with substantial experience may be considered for this position.
- Must have a minimum of 3-5 years relevant experience.
- Phase II/III Oncology trial experience strongly preferred/ solid tumor (breast cancer) is highly desirable.
- Experience working in both sponsor and CRO organizations strongly preferred
Sthree US is acting as an Employment Business in relation to this vacancy.