[Hiring] Medical Data Review Specialist II @Fortrea

Role Description

The Medical Data Review Specialist II is a senior member of the Global Medical Data Review Team with responsibility for execution of key Central Medical Review activities and assists senior staff and Medical Monitors in the execution of their responsibilities. The Medical Data Review Specialist II collaborates with the study team to execute central monitoring aspects of clinical trials to implement and comply with the central monitoring / Central Medical review portion of the Central Monitoring plan.

• Responsible for the preparation and conduct of Central Medical Review tasks across a series of sponsor projects.
• Conducts review of Central Medical Review under guidance of a Central Medical Review and/or Central Monitoring Plan.
• Communicates findings at the site and patient level.
• Performs ongoing Central Medical Review for multiple studies under guidance of a Medical Review Plan.
• Supports team to ensure Critical Data and Process Definition is completed with Data Management.
• Identifies and evaluates safety signals based on individual cases and cumulative data assessment.
• Ensures that tracking and status reporting are performed in a timely and accurate manner.
• Applies data to recommend any patient safety concerns.
• Contributes to the Risk Assessment and Categorization Tool for topics related to medical review.
• Supports the Data Expert with Critical Data and Process Definition and EDC design implementation.
• Drafts the Central Medical Review Configuration Plan and maintains it throughout the study.
• Drafts Central Monitoring / Central Medical Review Plans in collaboration with the study team.
• Performs ongoing Central Medical Review and discusses findings with the study team.
• Collaborates with other Central Monitoring activities to ensure consistency and effectiveness.
• Acts as subject matter expert based on education qualification/experience.
• Provides data-driven decisions and communicates findings proactively to key stakeholders.
• Prepares and distributes quality reports during study conduct and at study close out.
• Ensures filing of study documents in the central files in a central office or hub location.
• Takes responsibility for inspection readiness for medical assessment activities.
• Tracks Request for Proposal opportunities and Project/Studies and their status accurately.
• Proposes process improvements and solutions to current process issues.
• May support the implementation of ideas into systems and tools improvements.
• Provides training on the project and process to new team members.
• Mentors new team members.
• Any other duties assigned by supervisor.

Qualifications

• Medical Doctors, Allied medical degrees, Post-graduation in Life sciences or any other applicable qualifications.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Language Skills: Speaking: English required, Writing / Reading: English required.

Requirements

• Medical doctors with 3-5 years of experience in medical practice/equivalent clinical research roles.
• Paraprofessionals and Life science graduates with 5-7 years of clinical research/equivalent experience (e.g., clinical monitoring, data management, Medical Data review, informatics).

Benefits

• Standard office or home working equipment required.
• Minimal travel required.
• Regional travel requirements.