Medical Data Review Mgr

2+ years

Not Disclosed

Bangalore

10 Nov. 6, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Medical Data Review Manager
Company: Fortrea
Location: Bangalore, India (Remote Flexibility, Working Hours: 2 PM - 11 PM IST)
#LI-Remote

About Fortrea:

Fortrea is a global leader in clinical research, offering pharmaceutical, biotechnology, and medical device clients cutting-edge solutions across over 20 therapeutic areas. With a strong focus on scientific rigor and decades of experience in clinical development, we operate in more than 90 countries, working to transform the way drugs and devices are developed for patients worldwide.

Job Summary:

The Medical Data Review Manager is a key member of the Global Medical Review Team at Fortrea, responsible for executing critical medical data review activities and collaborating with the study team to monitor clinical trials. This role plays a central role in overseeing the implementation of risk plans, ensuring compliance, and supporting clinical deliverables. You will leverage your expertise in medical data review, contribute to the development of key tools like Xcellerate® Medical Review, and work closely with senior leadership to ensure smooth project execution across multiple sponsor projects.

Key Responsibilities:

Central Medical Review & Oversight:
Lead the preparation and execution of Central Medical Review tasks from tool launch through to study report completion, ensuring compliance with all relevant regulations.
Proposal & Strategy Development:
Collaborate in the development of Central Monitoring proposals, including costing, strategy, and proposal text, particularly when Central Medical Review is a key component.
Tracking & Status Reporting:
Ensure timely and accurate tracking and reporting of clinical data review activities.
Safety Signal Detection & Evaluation:
Identify and assess safety signals based on individual cases and cumulative data, using signal detection systems to highlight potential patient safety concerns.
Risk Assessment Contribution:
Contribute to the development and refinement of the Risk Assessment and Categorization Tool, particularly in relation to medical review topics and study configuration.
Configuration of Xcellerate® Medical Review Tool:
Lead the configuration of the Xcellerate® Medical Review tool, ensuring study-specific visualizations are programmed and perform user acceptance testing to ensure functionality.
Collaboration with Project Physicians:
Work closely with internal and/or client Project Physicians to address and resolve identified issues, ensuring that findings are appropriately communicated and documented.
Ongoing Data Review & Decision Making:
Continuously perform Central Medical Review and provide data-driven decisions to stakeholders, proactively addressing any findings or issues.
Inspection Readiness & Regulatory Support:
Ensure inspection readiness for all medical assessment activities, supporting regulatory authority inspections when necessary.
Process Improvement:
Evaluate and submit process improvement suggestions to leadership, including justification for any proposed changes to systems or tools.
Training & Development:
Provide training and mentorship to new team members, ensuring they are well-equipped to support project-specific medical review processes.

Qualifications:

Education & Experience:

Required:
- Medical Doctor (MBBS / MD)
- 6-7 years of experience in Medical Data Review or related clinical roles.
- Comfortable working from Bangalore, with hours of 2 PM to 11 PM IST.

Skills & Competencies:

Medical Data Review Expertise:
Strong knowledge of medical data review processes, safety signal detection, and risk assessment methodologies.
Tool Configuration & Testing:
Experience with Xcellerate® Medical Review or similar tools, including programming and user acceptance testing of data review visualizations.
Collaboration & Communication:
Proven ability to work closely with cross-functional teams, including Project Physicians and senior leadership, to ensure high-quality data and project outcomes.
Problem-Solving & Decision-Making:
Data-driven decision-making skills with the ability to identify, evaluate, and resolve medical data issues proactively.
Regulatory & Compliance Knowledge:
Strong understanding of GxP, regulatory requirements, and inspection readiness for medical review activities.

Why Fortrea?

At Fortrea, we are committed to fostering an inclusive, innovative work environment where your contributions are valued and supported. Join us in advancing the future of clinical trials and the development of therapies that can change lives.

Fortrea is an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea values diversity and inclusion, and does not tolerate harassment or discrimination of any kind. We base employment decisions on business needs and individual qualifications, and we encourage all qualified candidates to apply.

For more information about Fortrea and to apply, visit www.fortrea.com.

Application Deadline:
Applications will be accepted on a rolling basis until the position is filled.

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