Consultant / Senior Project Manager
* Job Description: Manager of clinical operations aspects for the CR845 clinical program to coordinate and manage interactions with and oversight of CROs , contracts and interactions with investigators, other services and vendors. Set up and maintenance of TMFs and assist in the preparation of regulatory documents such as Annual Reports and Clinical Monitoring Plans.
* Requirements: Science background RN, MS, MSN or other equivalent training with 4-7 years in clinical research at pharmaceutical, biotech or CRO companies. Solid understanding of ICH-GCPs, and FDA regulations and proven experience in dealing with all aspects of clinical operations. Travel – 10 to 15 % .
* Job conditions: Consultant / Independent contractor to work minimum three days on site up to 40 hours per week. The duration of the temporary contract is for 3 months expandable to 6 months; Competitive hourly rate.
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