Senior Analyst - Clinical Data Management

4 - 6 years

10 - 16 Lacs

Posted:None| Platform: Naukri logo

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Work Mode

Hybrid

Job Type

Full Time

Job Description

Key Skills:

Roles and Responsibilities:

  • Act as the Trial Data Manager for 3-4 studies simultaneously, while overseeing data management for additional trials.
  • Provide leadership in defining and executing data management plans across the study lifecycle.
  • Review clinical protocols and offer feedback to enhance clarity and optimize data collection design.
  • Lead the planning and execution of eCRF design, database development, and UAT processes.
  • Manage and validate external data according to protocol requirements and predefined standards.
  • Ensure timely and accurate data cleaning, query resolution, and database lock activities.
  • Monitor trial progress and milestones; provide status updates and risk assessments to stakeholders.
  • Collaborate closely with the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM).
  • Enforce data standards including CDISC/CDASH and ensure regulatory compliance across trials.
  • Mentor and support junior team members by sharing knowledge and promoting best practices.
  • Maintain compliance with GCP, SOPs, and applicable regulatory guidelines.
  • Stay informed about emerging tools, technologies, and industry data standards.

Skills Required:

Must-Have

  • Strong experience in Clinical Data Management and Clinical Programming
  • Ability to manage multiple studies independently, ensuring quality and regulatory compliance
  • Solid understanding of clinical trial processes, GCP, and data standards (e.g., CDISC)
  • Experience with eCRF design, EDC systems, and data validation workflows

Nice-to-Have:

  • Familiarity with Medical Imaging or Imaging data within clinical trials
  • Exposure to Veeam or similar imaging data management platforms
  • Experience mentoring or managing junior data management professionals
  • Knowledge of SAS, R, or other clinical programming tools is a plus

Education:

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