Medical Data Review

Key Responsibilities

• Central Medical Review: Conduct ongoing reviews for multiple studies under the guidance of a Medical Review Plan, communicating findings at the patient level with the team.
• Data and Process Definition: Support team to complete Critical Data & Process Definition, manage project team input, and implement critical data-focused EDC design.
• Safety Signal Evaluation: Identify and evaluate safety signals based on individual cases and cumulative data assessment using other signal detection systems.
• Tracking and Reporting: Ensure timely and accurate tracking and status reporting; apply data to recommend patient safety concerns.
• Risk Assessment: Contribute to the Risk Assessment and Categorization Tool for medical review topics, considering risks when planning tool configuration.
• Requirements Development: Support the development of medical review requirements, including visualization design, considering data feeds for the study (EDC, laboratory, etc.).
• Configuration Plan: Draft and maintain the Central Medical Review Configuration Plan, including re-versioning as required.
• Plan Drafting: Collaborate with the study team to draft Central Monitoring/Central Medical Review Plans, updating them as necessary, including refining visualizations and data changes.
• Consistency and Effectiveness: Collaborate with other Central Monitoring activities to ensure consistency and effectiveness.
• Subject Matter Expert: Act as a subject matter expert based on education and experience.
• Data-Driven Decisions: Provide data-driven decisions and communicate findings proactively and effectively to key stakeholders.
• Quality Reports: Prepare and distribute quality reports at intervals during study conduct and at study closeout.
• Documentation: Ensure filing of study documents in central files or hub locations.
• Inspection Readiness: Take responsibility for inspection readiness for medical assessment activities and support regulatory authority inspections when needed.
• Proposal Tracking: Track Request for Proposal opportunities and Project/Studies status accurately.
• Process Improvement: Propose process improvements and solutions to current process issues; support the implementation of ideas into system and tool improvements.
• Training and Mentoring: Provide training on the project and process to new team members; mentor new team members.
• Additional Duties: Perform any other duties assigned by the supervisor.

Qualifications

• Education: Medical Doctors (MBBS); Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Language Skills: Proficiency in English (speaking, writing, and reading).

Experience

• Required: Medical doctors (MBBS) with 1-3 years of experience in medical practice or equivalent clinical research roles.