Lead Clinical Data Specialist

1 week ago

Remote, India beBeeMedicalDataReview Full time ₹ 15,00,000 - ₹ 28,00,000

Medical Data Review Expert

We are seeking a highly skilled Medical Data Review Expert to join our team.

Job Description:
  • Perform thorough medical data reviews to ensure compliance with regulatory guidelines, sponsor/client directives, and GCP standards.
  • Contribute to the design of eCRF fields relevant to medical data review, utilizing clinical expertise and knowledge of data management principles.
  • Develop, input, and review project-specific Medical Data Review Plans (MDRPs) or equivalent documents, ensuring accuracy and completeness.
  • Implement medical data review tools, including listings, patient profiles, and visual analytics software.
  • Review diverse types of medical data, such as vital signs, laboratory tests, ECG results, imaging results, adverse events, and efficacy assessments.
  • Generate and review medical queries, assisting in their closure and resolution.
  • Prepare project-specific reports and provide training for new team members on medical data review processes and tools.
  • Attend project meetings and data review sessions as required.
  • Verify medical coding for accuracy and re-code as necessary.
  • Document significant communications with sites, clients, and internal teams.
Required Skills and Qualifications:
  • Hold a degree in Physician Assistant, MBBS/MD, Nurse Practitioner, or equivalent.
  • Have at least one year of clinical experience post-degree and two years in the Pharmaceutical, Biotech, Medical Device, or CRO industry with clinical data.
  • Desirable: Experience in medical or drug development environments performing medical data reviews using visual analytics programs.
Benefits:
  • Proficient in computer use and EDC programs.
  • Valid driver's license and ability to travel up to 10% if needed.
  • Able to work remotely.
Others:
  • Attention to detail and creative problem-solving skills.
  • Excellent time management and prioritization skills.
  • Effective communication skills in English, both oral and written.
Key Skill Keywords: Medical Data Review

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