Accenture-Clinical Research Associate Openings BangaloreJuly 26th, 2010 Posted by VFreshers
Job Position : Clinical Research Associate – SDTM Mapping
Experience : 1 – 5 Years
Job Location : Bengaluru/Bangalore
Job Responsibilities :
- Manage the EDC technical shared service activities for SDTM mapping to assure delivery for Electronic Data Capture (EDC) studies. Collaborate with Client groups and Study Designers to understand the protocols, requirements and timelines, work with Data Mapping Lead, Data Mapping Associates, Deployment Specialists and process SME during development and testing for clinical studies.
- Understand the usage of CDISC SDTM Guidance rules to annotate eCRFs with SDTM domains and variables.
- Identify the required SDTM domains required based on CRF data
- Identify the standard SDTM domains and assign to CRF
- Identify the protocol specific SDTM domains and assign to CRF
- Prepare and finalize SDTM Mapping Specification, Define.xls and other technical deliverables for each study.
- Serve as a project point of contact. Ensure that development functions are aligned to meet Project Management timelines and deliverables.
- Manage the project plan, identify and communicate relevant changes proactively, identify risks and manage risk mitigation plans with all relevant personnel.
- As needed liaise with client teams (e.g data vendors, SPAs, PDAM support, etc.) to ensure all components needed for accurate and timely development is completed as needed
- Maintain appropriate documentation as required by SOPs and job aides. Ensure Study files are stored appropriately in the official repository or client documentation archives as required.
- Understand and work to the current divisional / departmental SOPs, job aides, ensuring deviations are documented appropriately. Propose new and revise current procedures as appropriate.
- Maintain a strong working knowledge of Global SDTM standards and champion its use to ensure compliance with standards, and for making formal requests to Client Standards team for logical changes or enhancements to standards. Support study teams, in their submission of documentation for the creation or modification of standards.
About company :
Accenture is a global management consulting, technology services and outsourcing company. Combining unparalleled experience, comprehensive capabilities across all industries and business functions, and extensive research on the world’s most successful companies, Accenture collaborates with clients to help them become high-performance businesses and governments. With approximately 177,000 people serving clients in more than 120 countries, the company generated net revenues of US$21.58 billion for the fiscal year ended Aug. 31, 2009.
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