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Medical Data Reviewer

2 months ago

Bengaluru, India Stafford Information Technology Pvt Ltd Full time

Responsibilities

  1. Experienced Medical Data Reviewer (MDR) for our clinical research team.
  2. Perform in-depth medical data review to assess data accuracy, subject safety, and protocol compliance, with emphasis on oncology therapeutic areas incl. non-small cell lung cancer, small cell lung cancer, malignant melanoma etc.
  3. Perform Risk-Based Monitoring (RBM) and centralized monitoring to identify data trends and potential risks early, addressing them proactively w relevant study teams.
  4. Support SAE reconciliation, coding review, lab data analysis, and ensure regulatory compliance across trials.
  5. Collaborate with data management, clinical operations, biostatistics, and pharmacovigilance teams to ensure integrated data review processes.
  6. Document and maintain detailed records, prepare Medical Data Review Plans (MDRPs), and provide insights to optimizing data quality procedures.
  7. Utilize various software tools such as TIBCO Spotfire, Medidata Rave, and Oracle Clinical for effective data tracking and resolution.


Qualifications

  1. Degree in Medicine (MBBS/MD) or Dentistry (BDS/MDS) is a requirement.
  2. Minimum 5+ years of experience in Medical Data Review, Risk-Based Monitoring and Centralized Monitoring settings.


Skills

  1. Proficient w various EDC platforms incl. Medidata Rave, Oracle Clinical
  2. Knowledge of data reporting/visualization tools like TIBCO Spotfire.
  3. Thorough understanding of pharmacovigilance, safety and efficacy data review
  4. Experience with oncology trials and medical coding standards.
  5. Understanding of US and EU drug safety regulations, CIOMS and ICH guidelines.
  6. Knowledge of MS-Office (Excel, Word, PowerPoint, etc.)
  7. Excellent English written and verbal communication skills.