Senior Clinical Study Manager Job

CLINICAL STUDY MANAGER needed for a CONTRACT opportunity with Yoh's client in WOODCLIFF LAKE, NJ.

WHAT YOU'LL BE DOING:

- The Clinical Study Manager is primarily responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West in adherence to Good Clinical Practices(GCPs), appropriate Standard Operating Procedures, FDA regulations and ICH guidelines.
- Provide 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
- The Clinical Study manager is a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy.
- Develop project cross-functional, integrated study plan to study start up and validate and manage to the overall study plan provided by the CRO.
- Contribute to operational delivery aspects of the protocol and take a document reviewand the transmittal of trial and site level documents to the Document Control Center (DCC) in support of the Trial master File (TMF).
- Support department in codifying existing knowledge and best practices.

WHAT YOU NEED TO BRING TO THE TABLE:

- Minimum of a Bachelor of Science degree in a relevant scientific discipline.
- Minimum of five (5+) years of experience in the pharmaceutical industry in a clinical study or trial management role.
- Experience managing Oncology trials, Phase I-IV, preferred.
- Experience using EDC Platform (Inform).

GET HIRED. APPLY NOW!

RECRUITER: Tonya Allen

Yoh, a DayJ2W: CLINICAL; MONJOB

TAX TERM: CON_W2J2WNECLIN

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SFSF: LS