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Clinical Data Manager II

External
calyx logoCalyx · Hyderabad, India
Full-timeOn-site3w ago
Compliance
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Responsibilities

  • Primary
  • Design study CRFs and databases utilizing eCRF library
  • Create study Data Management Plan and deployment roadmap
  • Monitor study timelines and communicate risk
  • Develop database edits, rules, and derivations
  • Prepare tracking reports and metrics
  • Facilitate study team involvement in database development
  • Prepare data extracts and processing for sponsor deliverables
  • Communicate with sponsors regarding study data processes, endpoints, and overall data management process
  • Other
  • Carryout any other reasonable duties as requested.
  • Functional Competencies (Technical knowledge/Skills)
  • Technical project management and oversight
  • Task creation and tracking via ticketing software
  • Proficient with clinical data management systems
  • Experience working with research support or clinical team
  • Experience, Education, and Certifications
  • Bachelor's Degree in Life Science (Biology, Medical Technology, Research Psychology, Math or Health Science or equivalent experience in a related field
  • 5-7 years practical work experience in a clinical or technical setting
  • Demonstrated experience in team settings to achieve goals
  • Demonstrated experience with clinical data management systems
  • Experience working with research support or clinical team
  • English: Fluent
  • Come as you are.

Benefits

Health insurance

Additional Information

We're on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs & trainings The Clinical Data Manager II is an end-to-end data custodian and plays a key role in managing data and ensuring its accuracy, completeness, and compliance with regulatory standards while providing data management support to study teams. The Clinical Data Manager excels in defining overall data standards, data collection requirements, data import, extraction, reporting, and analysis methods. The incumbent shall demonstrate a strong working knowledge of Good Clinical Data Management Practices.


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