Medical Data Review Specialist Ii

1-3 years years

upto 9 LPA

9 July 9, 2024

Job Description

Job Type: Full Time Education: MBBS / MD (Pharmacology) Skills: Causality Assessment, Communication Skills, GCP guidelines, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Medical Data Review Specialist II

Location: Bangalore, India
Time Type: Full-time
Posted On: Posted Yesterday
Job Requisition ID: 2426232

Company: Fortrea

About Fortrea

Fortrea is 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. With over 19,000 staff operating in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. For more information, visit www.fortrea.com.

Job Summary

The Medical Data Review Specialist II is a senior member of the Global Medical Data Review Team, responsible for executing key Central Medical Review activities and assisting senior staff and Medical Monitors. This role involves collaborating with the study team to execute central monitoring aspects of clinical trials and ensuring compliance with the Central Monitoring/Central Medical Review Plan.

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.

Additional Information

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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