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Position: Data Manager – Clinical Data Sciences
Location: Chennai, Tamilnadu, India
As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Senior Associate Data Manager is responsible for timely and high-quality data review and query management of clinical data supporting the Pfizer portfolio. The Data Manager I executes on key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data.
- 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 Data Manager 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
- Awareness of clinical development and pharmaceuticals as a regulated industry
- Awareness of healthcare regulatory authorities (e.g. FDA, Health Canada)
- Ability to learn clinical data management processes and principles in the area of responsibility.
- Demonstrates required verbal and written communication skills including the ability to communicate remotely
- Capable to learn technical data systems
- Capable to learn how to use data visualization tools (e.g. Spotfire, J-Review)
- Awareness of MedDRA/WHO-Drug preferred
- Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
- Bachelor’s degree minimum requirement. Health Sciences experience or Technology degree preferred.
- At least 4 years of experience in Clinical Data Management, performing complete data review activities, in a CRO or a Pharma Company.