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.