Key Responsibilities:
- Perform medical data review tasks to ensure compliance with applicable SOPs, Sponsor/Client directives, and GCP guidelines.
- Review and contribute to the design of eCRF fields relevant to medical data review.
- Develop, input, and review project-specific Medical Data Review Plans (MDRPs) or equivalent documents.
- Implement medical data review tools, including listings, patient profiles, and visual analytics.
- Review various types of medical data, including 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-specific reports and provide training for new team members on medical data review processes and tools.
- Attend project-specific meetings and data review meetings as required.
- Review medical coding for accuracy and re-code as necessary.
- Document significant communications with sites, clients, and internal teams.
- Perform additional tasks and responsibilities as assigned.
Additional Responsibilities (as needed):
- 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 meetings with clients as requested.
Supervisory Responsibilities:
- No supervisory responsibilities.
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 (e.g., Spotfire, Tableau, Power BI) and experience in oncology studies.
Skills/Competencies:
- 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).
- Must possess a credit card for travel expenses.
- Ability to work remotely.
