Non-Clinical Job at Fortrea

Fortrea job openings are now live: Fortrea is hiring an Associate Medical Data Review Manager for its Global Medical Review Team. This non-clinical job involves executing key Central Medical Review activities within the Central Monitoring strategy. Minimum qualifications include Medical Doctors, Allied medical degrees, or Post-graduation in Life sciences.

About Fortrea:

Fortrea is a prominent organisation in the life sciences sector, focusing on delivering innovative solutions in clinical development and data management. With a commitment to advancing healthcare, Fortrea operates globally, providing expertise in medical data review and clinical trials. The company is dedicated to ensuring the highest standards in medical review processes and patient safety

Job Details:

Job Title: Associate Medical Data Review Manager
Team: Global Medical Review Team
Job ID: 263299

Job Description:

The Associate Medical Data Review Manager is an important member of the Global Medical Review Team with responsibility for execution of key Central Medical Review activities within the Central Monitoring strategy, such as: collaborating within a matrix environment, communicating proactively internally and externally and across functions with key stakeholders to ensure Central Monitoring/Central Medical Review Plans are proactively and effectively executed to meet client expectations. Responsible for the preparation and conduct of Central Medical Review tasks across a series of sponsor projects commencing with Xcellerate® Medical Review tool launch up to and including the study report. Conduct reviews of Central Medical Review under guidance of a Central Medical Review Plan and communicate findings at the site, patient level. This review is performed with oversight by the Project Physician, who also acts as an escalation point for the Medical Reviewer-Central Monitoring. Provides Central Medical Review support to the study team and to the client.

Key Responsibilities of the Non-Clinical Job

Collaborates in the development of Central Monitoring proposal text and review of costing, contributes to proposal strategy and development when Central Medical Review is included.
Supports Sponsor presentations/bid defences.
Ensures that tracking and status reporting are performed in a timely and accurate manner.
Applies data to recommend any patient safety concerns.
Identifies and evaluates safety signals based on individual cases and cumulative data assessment and by using other signal detection systems.
Contributes to the Risk Assessment and Categorisation Tool for topics related to medical review and considers risks when planning Xcellerate® Medical Review configuration.
Supports the Data Expert with Critical Data and Process Definition and EDC design implementation.
Supports the development of medical review requirements, including design of the visualisations, taking into consideration the data feeds for the study (EDC, laboratory, etc.).
Drafts and finalises the Central Medical Review Configuration Plan and maintains this Plan throughout the study, including re-versioning as required.
Drafts Central Monitoring/Central Medical Review Plans in collaboration with the Central Monitoring Manager (if applicable) and Project Physician and updates these on an ongoing basis including the refinement of visualisations and any change in data.
Manages configuration of Xcellerate® Medical Review (XMR) tool, programming of study-specific visualisations included in XMR and performs user acceptance testing of the tool.
Performs ongoing Central Medical Review, discusses findings with the Project Physician (internal and/or client) and ensures that identified issues are followed to resolution and, where required, that a report is written.
May 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.
Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed.
Collaborate with other Central Monitoring activities to ensure consistency and effectiveness.
Evaluate and collates process improvement suggestions and submits them to leadership.
Evaluates and submits ideas and justification for improved systems and tools to leadership.
Provides training on the project and process to new team members.
Mentoring of new team members.
All other duties as needed or assigned.
If acts as line manager, the following responsibilities apply:
Manage direct reports to ensure staff training records are up to date, ensure utilization targets are met to exceed target, per job grade.
Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.
Assist with recruitment of new staff.
Ensure the proper functioning of the tools and machinery, and their maintenance.
Convey the problems faced by the organisation to senior managers, etc., thus creating the basis for the top management to work upon.
Responsible for managing performance reviews and issues of direct reports.
Ensure the smooth functioning of the Central Monitoring department in the organisation.

Eligibility Criteria for Non-Clinical Job:

Qualifications (Minimum Required):

Medical Doctors, Allied medical degrees or any other applicable qualifications.
Fortrea may consider relevant and equivalent experience instead of educational requirements.

Experience (Minimum Required):

Fortrea may consider relevant and equivalent experience instead of educational requirements.

Additional Information:

Physical Demands/Work Environment:

Standard office or home working equipment required.
Minimal travel required.

Non-Clinical Job at Fortrea | MBBS Candidates Apply Now