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US-: Clinical Trial Manager

Date: 08-Jan-2015
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Clinical Trial Manager

Essential Functions

1. Manages/oversees the conduct and execution of assigned clinical trials and associated activities in accordance with Good Clinical Practices (GCP) and relevant national and international requirements 2. Assist with the review and determination of appropriate site and vendor selection and ensuring all vendors meet the predetermined program milestones 3. Interacts with internal and external groups (CROs, vendors, clinical sites, etc.) to facilitate clinical trials and achieve designated timelines 4. Oversees study timelines, clinical trial budgets, coordinates development of study plans, CRF's and other study reports 5. Reviews and approves monitoring reports as appropriate 6.. Participates in review of clinical trial data 7.. Reviews regulatory documentation for accuracy and completeness 8. Provides updates to annual reports, IB, etc. from the clinical trial prospective 9. Responsible for Investigator Meeting coordination and participation 10. Participates in periodic review and revision of departmental policies and SOPs to assure compliance with GCP and corporate policies. 11. Participates in special projects as appropriate 12. Maintains professional and technical knowledge by staying current on pharmaceuticals industry research and developments as appropriate; by utilizing the resources made available by the Company; and by sharing information with colleagues. 13. Escalates issues as appropriate to Sr. Clinical Trail Manager 14. Acts on constructive feedback to improve performance.

Minimum education requirements Bachelors

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BioTech FYI Center
http://biotech.fyicenter.com/