Clinical Study Manager Job

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

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Phase II Study Start-Up
- Experience with oversight and management of CRO

WHAT YOU'LL BE DOING:

- Responsible for supporting a phase 2 clinical trial in study start-up
- Collaborate with the therapeutic area team and project management to develop strategies and meet goals/timelines set forth by the team
- Oversight and management of CRO to ensure successful conduct of the clinical trial by managing daily study activities to ensure data integrity and quality
- Communicate with study sites and third-party vendors, proactively recognizes problem situations and inform team members to enable issue resolution
- Contribute to individual and team development through training initiatives and team building activities

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's degree in biological science, nursing, pharmacy or equivalent as a minimum
- Minimum 5 years experience in the pharmaceutical industry in a position performing clinical operations functions
- Experience in managing all aspects of study progress from start-up to close-out activities to assure adherence to intended timeline to achieve study goals while ensuring good clinical practice compliance in accordance with FDA, GCP, and ICH guidelines
- Electronic data capture experience, particularly Inform, as a plus
- Experience in coordinating interdisciplinary activities involving study start-up: investigator meeting planning, case report form development, study drug supply design and ordering, development of contracts and budgets, data base set-up, regulatory document filing
- Experience in the Alzheimer's Disease therapeutic area preferred, but not required

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Chelsea Tevis

Yoh, a DayJ2W: SCIENTIFIC; MONJOB

TAX TERM: CON_W2J2WMIDATL

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SFSF: LS