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Clinical Research & Ops Pro

  • Location: Northern California
  • Reference Code: 22573

The candidate offers sound medical and scientific understanding combined with strong business acumen.  This individual is currently VP of a CRO which provides data management, clinical operations, EDC programming and hosting, medical writing and biostatistics services.  As co-founder of this CRO, the candidate has helped to build a successful company, and has also been centrally involved in the development of 2 successful start-up pharmaceutical companies and 1 successful medical device company.

With graduate degrees and post-doctoral training in the life sciences, the candidate has worked as an epidemiologist in the past, and has spent the last 16 years running all aspects of clinical operations and development for both CROs and sponsor companies.  This has included direct supervision of all operational, data management and statistical teams and matrix supervision of medical writers, regulatory and safety teams.

The candidate has both written and supervised the writing of posters, abstracts and articles for medical conferences and journals and clinical documents including protocols, clinical study reports, regulatory briefing documents, INDs and NDAs.

This talent has managed over 55 clinical trial protocols, most of them global in nature, including 8 concurrent trials with a budget >$125MM and 50 direct reports.  The candidate manages multiple vendors and clients, is success oriented and self-motivated, and is very hands-on in their daily work.

The candidate has a history of putting standardized practices in place, operating very efficiently, managing large teams to complete all clinical trial related activities and working very closely with sponsor companies.

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