Senior Medical Data Reviewer

7 days ago


Remote, India beBeeMedicalDataReviewer Full time ₹ 9,00,000 - ₹ 12,00,000

Key responsibilities include performing medical data review tasks to ensure compliance with applicable guidelines and directives.

  • Perform medical data reviews to guarantee adherence to standards, client instructions, and regulations.
  • Contribute to the development of eCRF fields relevant to medical data review.
  • Design, input, and review project-specific Medical Data Review Plans or equivalent documents.
  • Implement medical data review tools, including listings, patient profiles, and visual analytics.
  • Review various types of medical data, such as 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 reports and provide training on medical data review processes and tools.
  • Attend meetings as required for projects and data reviews.
  • Review medical coding for accuracy and re-code as necessary.
  • Document communications with teams, clients, and sites.
  • Perform additional duties 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 client meetings as requested.

Job Requirements:

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

  • Experience: 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 and experience in oncology studies.

Skills & Qualifications:

  • 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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