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Clinical Data Manager
3 months ago
QUALIFICATIONS
- At least 4 years of experience in Clinical Data Management, performing complete data review activities, in a CRO or a Pharma Company.
- Bachelor's degree minimum requirement. Health Sciences experience or Technology degree preferred.
- Location- Chennai, Mumbai (Hybrid)
ROLE RESPONSIBILITIES
- Participate in DM activities including data review and query management, assist with quality database design including documentation, testing, validation, and implementation of clinical data collection tools, CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
- Assist with the required study specific DMM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
- Assist with operational excellence in collaboration with other Data Manager's and CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities.