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: Clinical Data Analyst II
Job Description
The Clinical Data Analyst II (CDA II) shall be responsible for data processing activities on a project and shall ensure quality standards according to SOPs and ICH-GCP. Areas of responsibility shall include; data cleaning and query generation, support in data entry and CRF tracking, medical coding, SAE reconciliation and quality support on projects The CDA shall support on project meetings and telephone conferences where required. The CDA shall support the Project Lead on a project on tasks as needed.
• Review the respective study protocol/CRF
• Perform data cleaning (manually or automatically) and generate DCFs.
• Perform medical coding
• Perform SAE reconciliation
• Development of project-specific status reports
• Support data entry for UAT and production
• Track and review CRFs
• Setup and review of study documents and ensure proper documentation on projects
• DM QC as assigned
• Review of study databases including data-entry screens
• Input in development of SOPs, improvement initiatives and processes
Candidate Profile
Skills
• Ability to work with cross-functional groups
• Ability to understand complex organizational relationships
• Willingness to work overtime
• Detail-oriented with ability to work creatively and flexible in a fast-paced environment
• Good English knowledge
• Good knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
• Basic knowledge of PC or Unix SAS
• Demonstrate a sound awareness of all relevant regulations, including GCP
Education
• Bachelor’s degree (or equivalent) in a life science field, medical qualification (e.g. Nursing) or relevant Data Management experience
Language Skills
• Good English knowledge
• At least 4 years’ experience in a similar role in the clinical research environment.
• Experience in using any EDC system or SAS is preferred.
Additional Information:
Experience: Min. 4 yrs
Location: Andhra Pradesh - Hyderabad
Functional Area: CR
Requisition: pare-10033145
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 23th July, 2014
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