Clinical Data Manager | Cipla | Mumbai

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