Medical Data Review Associate Manager

4 weeks ago

Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

The Central Medical Review Team is an important part of the Global Medical Review Team with responsibility for execution of key Central Medical Review activities within the Central Monitoring strategy.

Key responsibilities include:

  • Collaborating within a matrix environment, communicating proactively internally and externally and across functions with key stakeholders to ensure Central Monitoring/Central Medical Review Plans is 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 communicates 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.
  • Provide Central Medical Review support to the study team and to the client.

Summary of Responsibilities:

  • 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.
  • Support Sponsor presentations/bid defenses.
  • Ensures that tracking and status reporting are performed in a timely and accurate manner.
  • Applies data to recommend any patient safety concerns.
  • Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems.
  • Contributes to the Risk Assessment and Categorization 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 visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.).
  • Drafts and finalizes 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 visualizations and any change in data.
  • Manages configuration of Xcellerate Medical Review (XMR) tool, programming of study specific visualizations included in XMR and performs user acceptance testing of the tool.
  • Performs ongoing Central Medical Review, discusses findings with 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.
  • Collaborates with other Central Monitoring activities to ensure consistency and effectiveness.
  • Evaluates and collates process improvement suggestions and submits to leadership.
  • Evaluates and submits ideas and justification for improved systems and tools to leadership.
  • Provide training on the project and process to new team members.
  • Mentoring of new team members.
  • All other duties as needed or assigned

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