India – Chennai
ROLE RESPONSIBILITIES
- Participate in DMM 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, supporting the database set up activities as assigned by Senior Data Manager or Clinical Data Scientist.
- Ensure work carried out in accordance with applicable SOPs and working practices.
- 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