Medical Data Review Specialist
3 days ago
The Medical Data Reviewer will be responsible for performing medical data review, focusing on relevant safety and efficacy parameters, as defined in the Medical Data Review Plan (MDRP) developed for each project. This role may also involve associated tasks, such as query formulation and review for closure, documentation of reviews, and/or completion of summary reports.
Key ResponsibilitiesThe successful candidate will perform the following tasks:
- Conduct medical data review to ensure adherence to SOPs, guidelines, and contract requirements.
- Review and input into the design of eCRF fields relevant to medical data review.
- Develop, input, and/or review project-specific Medical Data Review Plans (MDRPs) or equivalent documents.
- Implement medical data review tools, including listings, patient profiles, and visual analytic templates.
- Review and/or input into the review of various types of medical data, such as vital signs, physical examination results, laboratory tests, and adverse events.
- Generate, review, and/or input into the review/closure of medical queries.
- Prepare project-specific reports.
- Train new team members in medical data review processes, goals, and tools, as requested.
- Attend internal and external project-specific meetings, if requested.
- Review medical coding to ensure medical reasonability of codes and re-coding items, as needed.
The ideal candidate will possess the following qualifications:
- Education: Physician Assistant, MBBS/MD, Nurse Practitioner (or country-specific equivalent) required.
- Experience: At least 1 year of clinical experience post-degree and at least 2 years of experience in the Pharmaceutical, Biotech, Medical Device, and/or CRO industry working with clinical data.
- Desirable experience: Working in a medical or drug development environment performing medical data review using visual analytics programs, implementing medical data review templates, and experience in oncology studies.
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