Job Overview:
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. He/she is responsible for the preparation and conduct of Central Medical Review tasks across a series of sponsor projects commencing with Xcellerate Medical Review tool, or similar, launch up to and including the study report. He/she conducts review of Central Medical Review under guidance of a Central Medical Review and/or Central Monitoring Plan and communicates findings at the site, patient level. This review is performed with oversight by the Medical Data Review expert, Project Physician who also acts as an escalation point for the Medical Reviewer.
Summary of Responsibilities:
- Performs ongoing Central Medical Review for multiple studies under guidance of a Medical Review Plan or any applicable documents and communicates findings at patient with Team.
- Support team to ensure Critical Data and Process Definition is completed with Data.
- Management and input from project team and supports implementation of critical data focused EDC design.
- Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems.
- 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 and considers risks when planning tools configuration.
- Supports the Data Expert with Critical Data and Process Definition and EDC design implementation.
- Support the development of medical review requirements, including design of the visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.).
- Draft the Central Medical Review Configuration Plan. Maintains this Plan throughout the study including re-versioning as required.
- Draft Central Monitoring /Central Medical Review Plans in collaboration with the study team and updates these on an ongoing basis including the refinement of visualizations and any change in data.
- Performs ongoing Central Medical Review, discusses findings with the study team.
- Collaborates with other Central Monitoring activities to ensure consistency and effectiveness.
- Act as subject matter expert based on education qualification/experience.
- Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.
- Prepare and distribute the quality reports at intervals during study conduct and at study close out.
- Ensures filing of study documents in the central files in a central office or hub location.
- Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed.
- Track 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.
- Provide training on the project and process to new team members.
- Mentoring of new team members.
- Any other duties assigned by supervisor.
- And all other duties as needed or assigned.
Qualifications (Minimum Required):
- 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,
Experience (Minimum Required):
- Medical doctors with 3-5 years of experience in medical practice/equivalent clinical research roles or Paraprofessionals and Life science graduates with 5-7 years of clinical research/equivalent experience e.g., clinical monitoring, data management, Medical Data review, informatics etc.
Physical Demands/Work Environment:
- Standard office or home working equipment required.
- Minimal travel required.
- Travel Requirements:
- Regional
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