Stafford Information Technology Pvt Ltd | Medical Data Reviewer | bangalore
3 weeks ago
Responsibilities
- Experienced Medical Data Reviewer (MDR) for our clinical research team.
- 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.
- Perform Risk-Based Monitoring (RBM) and centralized monitoring to identify data trends and potential risks early, addressing them proactively w relevant study teams.
- Support SAE reconciliation, coding review, lab data analysis, and ensure regulatory compliance across trials.
- Collaborate with data management, clinical operations, biostatistics, and pharmacovigilance teams to ensure integrated data review processes.
- Document and maintain detailed records, prepare Medical Data Review Plans (MDRPs), and provide insights to optimizing data quality procedures.
- Utilize various software tools such as TIBCO Spotfire, Medidata Rave, and Oracle Clinical for effective data tracking and resolution.
Qualifications
- Degree in Medicine (MBBS/MD) or Dentistry (BDS/MDS) is a requirement.
- Minimum 5+ years of experience in Medical Data Review, Risk-Based Monitoring and Centralized Monitoring settings.
Skills
- Proficient w various EDC platforms incl. Medidata Rave, Oracle Clinical
- Knowledge of data reporting/visualization tools like TIBCO Spotfire.
- Thorough understanding of pharmacovigilance, safety and efficacy data review
- Experience with oncology trials and medical coding standards.
- Understanding of US and EU drug safety regulations, CIOMS and ICH guidelines.
- Knowledge of MS-Office (Excel, Word, PowerPoint, etc.)
- Excellent English written and verbal communication skills.
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bangalore, India Stafford Information Technology Pvt Ltd Full timeResponsibilitiesExperienced Medical Data Reviewer (MDR) for our clinical research team.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.Perform Risk-Based Monitoring (RBM) and...
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bangalore, India Stafford Information Technology Pvt Ltd Full timeResponsibilities Experienced Medical Data Reviewer (MDR) for our clinical research team. 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. Perform Risk-Based Monitoring (RBM) and...
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3 weeks ago
Bangalore, India Stafford Information Technology Pvt Ltd Full timeResponsibilities Experienced Medical Data Reviewer (MDR) for our clinical research team. 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. Perform Risk-Based Monitoring (RBM)...
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