ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: Clinical Data Co ordinator {CDC - I / II / III}
Description
Role Responsibility
Working within a highly qualified team you will perform data management activities to ensure the generation of accurate, complete, and consistent clinical databases. Fulfilling your job responsibilities in accordance with Good Clinical Practices (GCPs), ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), Study Specific Procedures (SSPs), International Committee on Harmonization (ICH) Guidelines, and all applicable laws and regulations.
Additional Responsibilities:
- Working independently and proactively you will Review Case Report Form (CRF) data for completeness, accuracy, and consistency identifying and resolving data discrepancies
- Update/correct/review data in the clinical databases based on resolved data queries
- Assist with the testing of data entry screens and the preparation of the relevant testing documentation.
- Create and maintain study files and other appropriate study documentation
- Dependent on level of experience you may assist in training and mentoring less experienced CDC’s.
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Candidate Profile:
With a University degree in medicine, science, or equivalent, you will have previous Data Management experience (for all roles above Entry Level). In addition, you will also require:
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Knowledge of ICH GCP guidelines and expertise to review and evaluate medical data
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Fluency in English
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Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner
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Ability to produce accurate work to tight deadlines within apressurisedenvironment
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Computer literate with Microsoft Office
You will have the opportunity to progress your career and may wish to move into Project Management or into other related areas where you can further develop your skill set.
Additional Information:
Experience: 0-1 years exp
Location: Trivandrum, Chennai
Education: B.Pharm, B.Sc, MBBS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Code: 10663, 11064
End Date: 17th Oct 2012
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