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 Job #02314 Email this job to a friend
About our client
Our client is a biotechnology company based in California. The company is mainly focused on the development of therapeutic agents that affect the blood vessels and blood flow in cancer and other diseases.
Position Location
Clinical Research Project Manager Southern California
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Oversee protocol design and implementation
2) Manage study start-up activities
3) Participate in site training
4) Oversee site management and visits
5) Ensure integrity of clinical data
6) Evaluate of clinical data
7) Ensure adherence to regulatory and company guidelines
8) Assist with regulatory filings
9) Participate in administrative activities as part of the project team
10) Oversee safety reporting
11) Ensure adherence to regulatory guidelines and SOPs
Requirements
1) Bachelor's degree (B.A.) in Life Sciences or equivalent
2) 5+ years of experience in pharmaceutical industry clinical/regulatory monitoring, including multi-center clinical studies
3) In-depth knowledge of GCPs and regulations
4) Experience in managing at least one multi-center study and other Phase 1-3 studies using CROs
5) Clinical Research certification (SoCRA, ACRP, DIA) preferred
6) Willingness to travel – upto 40% (domestic and international)

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