Medical Data Review

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.