PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post : Senior Clinical Data Analyst
Job Description
• Manage all phases of data management activities from study start up to database close, which may include:
‒ Development of database build specifications
‒ Development of data validation specifications
‒ Test data creation & UAT
‒ Performing/ leading functional QC activities and testing
‒ Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.
‒ Data validation and cleaning
‒ Conduct medical coding if assigned
‒ Conduct SAE & third party data reconciliations
‒ Perform early and final database QC activities
‒ Database lock activities ‒ Maintaining Clinical Study Documents and archiving as appropriate
• Responsible for completeness, timely delivery and quality of clinical data
• Lead and coordinate other team members within the department on assigned studies
• Mentor project team members and be a subject matter expert when needed
• Represent DM function in external client meetings and presentations such as investigator meetings as required. May represent PAREXEL at professional meetings / conferences
• Facilitate cross functional team meetings both internally and externally as needed
• Other assigned responsibilities as needed
Candidate Profile :
Must be able to demonstrate proficiency with several tasks included in data start-up through data-base lock. Previous relevant 4 to 7 years data management work experience required with solid understanding of clinical trials methodology and terminology desirable.
Additional Information:
Experience : 4 to 7 Years
Location : Karnataka - Bengaluru
Industry Type : Pharma / Biotech / Clinical Research
Functional Area : Data Management
Last date : 11th August, 2016
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