Medical Data Review

3 weeks ago

Bengaluru, Karnataka, India Thepharmadaily Full time
Job Description

Key Responsibilities

- Central Medical Review:Conduct ongoing reviews for multiple studies under the guidance of a Medical Review Plan, communicating findings at the patient level with the team.
- Data and Process Definition:Support team to complete Critical Data & Process Definition, manage project team input, and implement critical data-focused EDC design.
- Safety Signal Evaluation:Identify and evaluate safety signals based on individual cases and cumulative data assessment using other signal detection systems.
- Tracking and Reporting:Ensure timely and accurate tracking and status reporting; apply data to recommend patient safety concerns.
- Risk Assessment:Contribute to the Risk Assessment and Categorization Tool for medical review topics, considering risks when planning tool configuration.
- Requirements Development:Support the development of medical review requirements, including visualization design, considering data feeds for the study (EDC, laboratory, etc.).
- Configuration Plan:Draft and maintain the Central Medical Review Configuration Plan, including re-versioning as required.
- Plan Drafting:Collaborate with the study team to draft Central Monitoring/Central Medical Review Plans, updating them as necessary, including refining visualizations and data changes.
- Consistency and Effectiveness:Collaborate with other Central Monitoring activities to ensure consistency and effectiveness.
- Subject Matter Expert:Act as a subject matter expert based on education and experience.
- Data-Driven Decisions:Provide data-driven decisions and communicate findings proactively and effectively to key stakeholders.
- Quality Reports:Prepare and distribute quality reports at intervals during study conduct and at study closeout.
- Documentation:Ensure filing of study documents in central files or hub locations.
- Inspection Readiness:Take responsibility for inspection readiness for medical assessment activities and support regulatory authority inspections when needed.
- Proposal Tracking:Track Request for Proposal opportunities and Project/Studies status accurately.
- Process Improvement:Propose process improvements and solutions to current process issues; support the implementation of ideas into system and tool improvements.
- Training and Mentoring:Provide training on the project and process to new team members; mentor new team members.
- Additional Duties:Perform any other duties assigned by the supervisor.

Qualifications

- Education:Medical Doctors (MBBS); Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Language Skills:Proficiency in English (speaking, writing, and reading).

Experience

- Required:Medical doctors (MBBS) with 1-3 years of experience in medical practice or equivalent clinical research roles.

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