Medical Data Review Specialist II

6 days ago


Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time
Job Title: Medical Data Review Specialist II

Fortrea Development India Pvt Ltd is seeking a highly skilled Medical Data Review Specialist II to join our team. As a senior member of the Global Medical Data Review Team, you will be responsible for executing key Central Medical Review activities and assisting senior staff and Medical Monitors in their responsibilities.

Key Responsibilities:
  • Collaborate with the study team to execute central monitoring aspects of clinical trials, implementing and complying with the central monitoring/Central Medical review portion of the Central Monitoring plan.
  • Prepare and conduct 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 review of Central Medical Review under guidance of a Central Medical Review and/or Central Monitoring Plan, communicating findings at the site and patient level.
  • Support team to ensure Critical Data & Process Definition is completed with Data.
  • Manage 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, using other signal detection systems.
  • Ensure tracking and status reporting are performed in a timely and accurate manner, applying data to recommend any patient safety concerns.
  • Contribute to the Risk Assessment and Categorization Tool for topics related to medical review, considering risks when planning tools configuration.
  • Support the Data Expert with Critical Data and Process Definition and EDC design implementation.
  • Draft the Central Medical Review Configuration Plan, maintaining this Plan throughout the study, including re-versioning as required.
  • Draft Central Monitoring/Central Medical Review Plans in collaboration with the study team, updating these on an ongoing basis, including the refinement of visualizations and any change in data.
  • Perform ongoing Central Medical Review, discussing findings with the study team.
  • Collaborate 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 key stakeholders.
  • Prepare and distribute quality reports at intervals during study conduct and at study close out.
  • Ensure filing of study documents in the central files in a central office or hub location.
  • Take responsibility for inspection readiness for medical assessment activities, supporting regulatory authority inspections when needed.
  • Track Request for Proposal opportunities and Project/Studies and their status accurately, proposing 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.
Qualifications:
  • Medical Doctors (MBBS)
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Language Skills:
  • Speaking: English required
  • Writing/Reading: English required

Fortrea is a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.



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