Clinical Data Manager | Cipla | Mumbai
Job Overview
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Date PostedNovember 23, 2022
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Location (State / UT)
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Expiration date--
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Experience5 Years, 10 Years
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GenderAny
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Desired QualificationBachelor Degree, Master’s Degree
Job Description
Clinical Data Manager – Clinical R & D
Roles and Responsibilities
- Develop the data transfer agreement & data transfer specifications for vendor data transfers.
- Prepare and upkeep the File Format Specification Document detailing data collection specifications in accordance with the GDSR-Biomedical Global Data Standards and CDISC-Clinical Data Interchange Standards Consortium.
- Raise special GDSR-ticket requests in case of any study-specific requirement for a non-standard variable collected. Performs a wide range of Data Acquisition activities ensuring that the non-CRF data is collected as per data collection standards.
- Led the collection of non-CRF data during study set-up, conducted, and closeout activities across multiple studies, contributing to fit for quality. Responsible for data acquisition, specification, loading, and delivery of Non-CRF data across different vendors.
- Provide input during protocol review to ensure clarity of data collection requirements.
Desired Candidate Profile
- Candidate having 5+ years experience in clinical data management
- Handling database designing
- Patient study,
- PK Study.
Qualification: B.Sc, MS/M.Sc, M.Pharma
