Full-Time
TMF Reviewer 2
Posted on 7/31/2026
Fortrea
10,001+ employees
Global CRO providing Phase I-IV trials
No salary listed
Bengaluru, Karnataka, India
In Person
Travel is primarily within the home region or to other company locations, with less than 10% travel as required.
 Biology & Biotech (1) |
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- A bachelor's degree with a Life Sciences or Business focus, although relevant and equivalent experience may be considered in lieu of the educational requirement.
- A minimum of 6 to 10 years of experience working in a clinical research environment.
- A clear understanding of Good Clinical Practice and International Council for Harmonisation guidelines.
- Knowledge of regulatory and clinical document requirements.
- Knowledge of Microsoft Office products, web-based applications, and Adobe Acrobat Standard, with the ability to apply related knowledge regarding scanning and other software programs.
- Excellent interpersonal skills.
- Perform process, control, coordination, and approval of clinical trial documents.
- Manage electronic Trial Master Files, including Trial, Country, and Site artifacts, for clinical studies in accordance with Trial Master File processes while working with key study personnel.
- Perform document classification and Audit Ready Checks when applicable.
- Perform Trial Master File reviews, including reviews by project team members, Global Quality Control members, and other reviewers such as Central Trial Master File Reviewers.
- Map the sponsor's Trial Master File Index with respect to Fortrea UCV and Trial Master File Review when applicable, and perform quality control in the sponsor system when applicable.
- Maintain the Trial Master File in an audit-ready state for quality and compliance.
- Perform Audit Ready Checks on individual documents uploaded in the electronic Trial Master File system for every study, ensuring that context is accurate.
- Initiate the What's Missing process for all documents and ensure completeness of the Trial Master File for each study by tracking and obtaining missing, incomplete, incorrect, or inaccurate artifacts against the Trial Master File Plan and Index and study milestones.
- Comply with established performance metrics for Trial Master File reviews.
- Process and track final essential artifacts required throughout all phases of the study in accordance with Fortrea standard operating procedures, sponsor standard operating procedures, Good Clinical Practice, and International Council for Harmonisation guidelines.
- Identify operational issues related to the Trial Master File and manage their resolution.
- Gather data requested by the study team to support client status reports.
- Prepare the Trial Master File for quality assurance or sponsor audits and resolve findings by identifying and implementing corrective actions.
- Participate in client audits and regulatory inspections.
- Review and respond to Trial Master File content quality issues, identify trends per study and across programs, and alert management of trends.
- Collaborate with all members of the business process and systems team.
- Support overall client satisfaction for all studies.
- Participate in business improvement initiatives to drive quality, productivity, and continuous improvement of business processes.
- Maintain an understanding of applicable regulatory requirements.
- Attend internal or external study team meetings as required.
- Perform other duties as needed or assigned.
- Work in an office environment.
- Travel primarily within the home region or to other company locations, with less than 10% travel as required.
- A master's degree with a Life Sciences or Business focus.
- Equivalent experience within a clinical research environment of a minimum of 6 to 10 years may be substituted for education requirements.
- Experience working in clinical electronic systems.
Fortrea is a global contract research organization that provides clinical development services for the life sciences industry. It offers full service, functional service, and hybrid outsourcing models across Phase I–IV trials, clinical pharmacology, and consulting, serving biotech, biopharma, medical devices, and diagnostics. Its work is delivered through a network of investigators and specialized teams in approximately 100 countries, supporting trial design, execution, data management, and regulatory compliance. Fortrea’s approach combines its legacy experience from Covance and Labcorp with a pureplay CRO model to deliver fit-for-purpose solutions and agile project delivery. This positions it to manage trials across more than 20 therapeutic areas with scientific rigor and operational excellence. The company aims to bring predictability to clinical trial execution and help clients turn research ideas into real-world outcomes.
Company Size
10,001+
Company Stage
IPO
Headquarters
Durham, North Carolina
Founded
2023
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Simplify's Take
What believers are saying
- Fortrea reaffirmed 2026 revenue guidance of $2.55 billion to $2.65 billion.
- Fortrea reaffirmed 2026 adjusted EBITDA guidance of $190 million to $220 million.
- Leadership stability and inducement awards support finance execution and retention.
What critics are saying
- CFO turnover can disrupt budgeting, forecasting, and investor messaging.
- Guidance leaves little room for trial delays or client pushouts.
- The stock's elevated valuation magnifies disappointment from any execution miss.
What makes Fortrea unique
- Fortrea named Jason Knoblauch CFO on July 6, 2026.
- Knoblauch brings CFO experience from Clario and Curia.
- McConnell stays through transition, supporting financial continuity.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
401(k) Retirement Plan
401(k) Company Match
Unlimited Paid Time Off
Paid Vacation
Growth & Insights and Company News
6 month growth
↑ 27%1 year growth
↑ 27%2 year growth
↑ 27%Fortrea unveils Fortrea Intelligent Technology(TM) to help sponsors and sites run Smarter, more integrated trials. Fortrea Holdings Inc AI-enhanced suite of solutions features new and improved technology to empower efficiency, confidence and quality. Highlights: * Designed to transform clinical trial operations for sponsors, sites and study teams * Persona driven, AI-powered solutions automate workflows and streamline oversight to help improve trial speed, predictability and quality * Builds on Fortrea's flagship platform Xcellerate(R) to deliver near-real-time, role-based insights DURHAM, N.C., April 07, 2026 (GLOBE NEWSWIRE) - Fortrea (Nasdaq: FTRE), a leading global clinical research organization (CRO), today unveiled Fortrea Intelligent Technology(TM)(FIT), a suite of innovative technology solutions designed to transform clinical trial operations. By integrating persona-driven, AI-powered solutions that automate workflows, streamline oversight and elevate productivity, FIT helps enable sponsors, investigator sites and Fortrea project teams to deliver trials faster, with greater predictability, agility and quality. An Innovative, Intelligent Suite of Clinical Solutions FIT encompasses major enhancements to familiar Fortrea offerings, including the award-winning Xcellerate(R) platform, along with newly launched solutions designed to integrate all processes within the trial ecosystem. The suite boasts applications for biopharma and biotech customers across clinical pharmacology, clinical development and medical device development, and it can be deployed in both full service and functional service models, with select components available as software-as-a service (SaaS). FIT solutions are arranged into three pillars: * Lifecycle: Deliver Trials Faster with Confidence Solutions that help sponsors and sites progress clinical trials throughout each step of the clinical development journey. They help accelerate clinical trials by automating key steps, from pre-award to final eTMF. * Foresight: Turn Data into Actionable Insights Solutions that transform data into foresight, helping enable faster decision-making and proactive risk mitigation. They provide clarity, trend analysis and risk mitigation through intuitive dashboards that empower confident, near-real-time decisions and simplified oversight. * Companion: Empowering Study Teams to Work Smarter Persona-driven, AI-powered solutions that support more productive and efficient clinical trial operations. They help streamline study delivery, help boost productivity and enable collaboration. "We are at a remarkable moment in time, where the evolution of clinical trials is converging with unprecedented advancements in technology. Fortrea Intelligent Technology sits at this nexus," said Chief Information Officer Alejandro Martinez Galindo. "Built on decades of industry experience and direct sponsor and investigator site input, FIT delivers human-centered solutions that enable sponsors and sites to conduct trials more efficiently, with greater confidence and lower risk." Xcellerate(R) Anchors the Intelligent Suite Xcellerate(R), Fortrea's platform for Risk-Based Quality Management (RBQM), Central Monitoring and Oversight, is the foundation of the FIT offering. Recent enhancements deliver a modern, intuitive experience that integrates data across the trial ecosystem to provide near-real-time, role-based insights. With embedded AI and machine learning, Xcellerate(R) can analyze complex patterns, generate predictive signals and initiate automated workflows, reducing manual effort and enabling teams to focus on the critical human judgment required for successful clinical research. "We expect these Xcellerate(R) enhancements and the broader FIT platform will be game changers for our study teams and our clients," said Chief Operating Officer and President, Clinical Development Mark Morais. "Incorporating the responsible and ethical use of AI, these technologies enable a stronger research ecosystem and the ability to respond more quickly to what the data are telling us - all of which can make the difference in getting life-changing treatments to patients faster and more efficiently." Fortrea continues to expand the Fortrea Intelligent Technology portfolio, with additional solutions planned for future release. About Fortrea Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development solutions to the life sciences industry. Connectweb partner with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients. Fortrea provides phase I-IV clinical trial management, clinical pharmacology and consulting services. Fortrea's solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Its talented and diverse team, operating across approximately 100 countries, is scaled to deliver focused, agile solutions to clients globally. Learn more about how Fortrea is streamlining drug development at Fortrea.com and follow Connectweb on LinkedIn, X and Bluesky. Fortrea Contacts: Jennifer Minx (Media) - 919-410-4195, [email protected] Kate Dillon (Media) - 646-818-9115, [email protected] Tracy Krumme (Investors) - 984-385-6707, [email protected]
Fortrea, a global clinical research organisation, has unveiled Fortrea Intelligent Technology (FIT), an AI-enhanced suite of solutions designed to transform clinical trial operations for sponsors, sites and study teams. The platform builds on Fortrea's Xcellerate system to deliver persona-driven, AI-powered solutions that automate workflows and streamline oversight. FIT is organised into three pillars: Lifecycle, which accelerates trials from pre-award to final eTMF; Foresight, providing near-real-time insights and risk mitigation through intuitive dashboards; and Companion, offering AI-powered tools to boost productivity and collaboration. The suite is available for clinical pharmacology, clinical development and medical device development, deployable in full service and functional service models, with select components available as software-as-a-service.
Fortrea reported Q4 revenue of $660.5 million, down 5.2% year-over-year, and full-year revenue of $2.723 billion, up 1% and within guidance. Q4 adjusted EBITDA was $54 million, whilst full-year adjusted EBITDA reached $189.9 million. The company posted a Q4 GAAP net loss of $32.5 million. Management noted improving demand, with Q4 book-to-bill at 1.14x and backlog at $7.7 billion, driven by higher client engagement and increased biotech RFP flow. Fortrea exceeded cost-savings targets, delivering $153 million gross savings, and generated strong Q4 operating cash flow of $129.1 million. The company repurchased $75.7 million of senior notes and ended with over $600 million liquidity. For 2026, Fortrea guided revenue of $2.55–2.65 billion with adjusted EBITDA of $190–220 million.
Clinical research company Fortrea Holdings reports Q4 earnings tomorrow. Analysts expect revenues to decline 4.3% year on year, following a 1.8% decrease in the same quarter last year. Last quarter, Fortrea beat revenue expectations with $701.3 million, up 3.9% year on year, and issued full-year guidance exceeding analysts' forecasts. However, the company has missed Wall Street's revenue estimates multiple times over the past two years. Analysts have largely maintained their estimates over the last 30 days. Shares have declined 36.8% over the past month, underperforming the drug development inputs and services segment, which averaged a 1.1% decline. The stock currently trades at $10.98 against an average analyst price target of $16.44.
Fortrea, a global contract research organisation, has expanded its executive team with two appointments. Oren Cohen, who previously served as both chief medical officer and president of Clinical Pharmacology Services, will now focus solely on his CMO responsibilities, overseeing medical strategy, scientific leadership and governance across Fortrea's portfolio. Scott Dove has joined as president of Clinical Pharmacology Services, responsible for early clinical development solutions across Fortrea's global network. Dove brings over 25 years of drug development experience, most recently serving as chief operating officer at Aravive and holding leadership roles at PPD, Allergan and Furiex Pharmaceuticals. Both Cohen and Dove serve on Fortrea's Executive Committee. The company provides clinical trial management and consulting services across more than 20 therapeutic areas.