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WHAT
IN
Clinical Development Research Scientist
Job
Covidien
US
-
Hazelwood,
Missouri
Job Code - A5FBDFF5EE2637A7
Position - See Job Description
Job First Active on: Wednesday, October 28, 2009
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JOB DESCRIPTION: Clinical Development Research Scientist
The Clinical Development Research Scientist will provide study-level medical and scientific support for clinical development activities (Phase 1-3B) under the direction of the VP Clinical Research Group. Responsibilities include: writing and editing clinical strategy documents, clinical development plans, study protocols, study reports, integrated summaries, and other related documents across multiple projects and studies; providing input into design of study documents; assist in the review of subject level data including adverse event across a study with oversight by the Study Physician; assists with clinical meetings, and communication; provides support and contribute to regulatory filings and publication strategies. This position will work closely with other functional teams including the Clinical Operations group and Medical Sciences (e.g. Biostatistics, Pharmacokinetics, etc).
REQUIREMENTS - QUALIFICATIONS: Clinical Development Research Scientist
A clinically related science degree is desired, i.e. PhD, RPh, BSN-NP, PharmD, MPH, PA. Other advanced degrees will also be considered. However, relevant experience and capabilities are most important to determine job level
Must have 5+ years of Clinical Research experience gained working for a pharmaceutical, biotechnology or CRO
Solid medical/scientific writing skills required with appropriate clinical, scientific and medical knowledge to author and design and implement clinical protocol and other study documents. Working knowledge of statistics, data analysis and data interpretation. The ideal candidate will be able to operate independently within minimal supervision and will possess past Clinical experience which includes: literature analysis, providing input to the design and writing of clinical protocols, clinical reports, clinical development plans, CRFs, and other documents supporting clinical development and regulatory submission; ability to perform background research, review and evaluate clinical data in the generation of study concepts, protocols, reports, development plans and IND/NDA or ANDA submissions. As this position will also work closely with the clinical operations group, experience with the operational aspects of clinical trials and related activities such as investigator meetings, DSMB’s, and GCP/ICH are necessary. Excellent written and oral communication skills and a command of the English language are a must. Organizational and cross functional collaboration skills; proficient at MS Word, Excel, sharepoint and Powerpoint.
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