Clinical Data Review Specialist

1 day ago

Remote, India beBeeMedicalDataReviewer Full time ₹ 1,04,000 - ₹ 1,30,878

Job Summary

This role is responsible for conducting medical data reviews to ensure compliance with applicable guidelines and directives.

Responsibilities

  • Perform medical data review tasks to ensure compliance with SOPs, Sponsor/Client directives, and GCP guidelines.
  • Review and contribute to the design of eCRF fields relevant to medical data review.
  • Develop project-specific Medical Data Review Plans (MDRPs) or equivalent documents.
  • Implement medical data review tools, including listings, patient profiles, and visual analytics.
  • Review various types of medical data, including vital signs, laboratory tests, ECG results, imaging results, adverse events, and efficacy assessments.
  • Generate and review medical queries and assist in their closure.
  • Prepare project-specific reports and provide training for new team members on medical data review processes and tools.
  • Attend project-specific meetings and data review meetings as required.
  • Review medical coding for accuracy and re-code as necessary.
  • Document significant communications with sites, clients, and internal teams.
  • Perform additional tasks and responsibilities as assigned.

Additional Responsibilities

  • Collaborate with project teams on integrated data review, providing medical expertise.
  • Work closely with Safety/Pharmacovigilance, Project Management, Clinical Operations, Data Management, Biostatistics, and QA to ensure effective execution of medical data review functions.
  • Participate in meetings with clients as requested.

Qualifications

  • Physician Assistant, MBBS/MD, Nurse Practitioner (or equivalent).

Requirements

  • At least 1 year of clinical experience post-degree and 2 years in the Pharmaceutical, Biotech, Medical Device, or CRO industry with clinical data.
  • Highly desirable: Experience in a medical or drug development environment performing medical data reviews using visual analytics programs (e.g., Spotfire, Tableau, Power BI) and experience in oncology studies.

Skills

  • Clinical thinking with the ability to use data review tools and formulate effective queries.
  • Understanding of scientific principles behind therapies and disease-induced pathology.
  • Strong knowledge of the drug/device/vaccine development process and ICH GCP guidelines.
  • Excellent time management and prioritization skills.
  • Effective communication skills in English, both oral and written.
  • Attention to detail and creative problem-solving skills.
  • Team player with integrity and professionalism.

Capabilities

  • Proficient in computer use and EDC programs.
  • Valid driver's license and ability to travel (up to 10% if needed).
  • Ability to work remotely.

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