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 Job #02527 Email this job to a friend
About our client
Our client is one of the top producers and leading worldwide healthcare suppliers of over-the-counter pharmaceuticals and nutritional products for retail markets. The company develops, manufactures and markets generic treatment (Rx) drugs along with active pharmaceutical ingredients (API) and consumer products.
Position Location
Senior Project Manager New York
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Oversee administration and project management of multiple phase clinical trials (I-IV)
2) Take an active role in research and protocol development
3) Monitor in-house and on-site trials
4) Obtain clinical study reports
5) Oversee partnering companies on associated projects and ensure adherence to Good Clinical Practices (GCPs)
6) Oversee protocol/amendment development (including review of all applicable literature such as SBAs, FDA guidelines and other publications)
7) Design CRF and modify/create ICF, investigator brochures, study related forms/reports and source documents in collaboration with the CRO, Data Management Group and Bio-statistician
8) Handle all project related budget/finance issues and maintain financial records
Requirements
1) Advanced bachelor’s degree in a scientific discipline
2) Minimum 5-7 years of project management experience in clinical research
3) Minimum 2 years of experience as a Clinical Research Associate
4) Experience in protocol development and monitoring in-house and on-site trials
5) Demonstrated ability to work both independently and in a team environment
6) Demonstrated ability to manage and prioritize multiple projects
7) Willingness to travel – 15-25%

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