Fortrea

Administration

• The Senior Clinical Trial Administrator (Sr. CTA) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project.
• Communicate with project team members regarding study updates.
• Maintain documentation as required by protocols, SOPs and regulatory standards.
• Provide systems support and track information related to the status of study activities.
• Assist with general administrative functions as required.
• Document and track study activities using relevant forms and tools.
• Assist in the preparation of study and site-specific materials in accordance with relevant SOPs.
• Complete minute taking and documentation for sponsor/external or internal teleconferences as requested.
• Provide support to project team including proof-reading and editing correspondence, assembling study documents, and arranging meetings.

Senior Clinical Trial Administrator

Project Manager

• Oversee and manage domestic, regional and/or global projects
• Develop and manage project teams
• Ensure operational delivery with regards to agreed time, scope, cost, and quality
• Serve as key client contact for assigned projects
• Lead core project team(s) and facilitate team’s ability to lead extended project team(s)
• Proactively identify and resolve conflicts
• Understand the project delivery strategy and budget
• Lead quality control and risk assurance activities
• Create and manage variance to required project plans
• Train and mentor PM Academy PCs in multiple areas of expertise

Senior Project Manager – Oncology

Manager

• Act as the primary point of contact for global mobility and U.S. immigration matters.
• Manage all aspects of U.S. immigration compliance, including visa applications, renewals, and tracking expirations.
• Develop and maintain global mobility policies and processes, ensuring scalability and compliance.
• Advise HR and business leaders on immigration issues and legislative changes.
• Partner with external vendors for immigration case management and ensure service-level agreements are met.
• Prepare annual immigration budgets and monitor costs.
• Maintain internal communication platforms and resources for employees and managers.
• Support international assignments and transfers, including cost projections and compliance reviews.
• Deliver training on immigration and mobility topics to HR, managers, and leadership.
• Monitor and implement changes in immigration laws and propose policy updates.
• All other duties as needed or assigned.

Global Mobility and US Immigration Manager

Research Analyst

• Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements.
• Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
• Prepares and implements project plans related to Clinical Monitoring responsibilities.
• Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
• Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
• Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
• Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
• Ensures adherence to global quality control and CRA performance metrics.
• Ensures audit readiness at site level.

Clinical Research Associate II

Call Center Representative

• Respond to medical information queries/product quality complaints/general queries
• Execute drug safety data management processes – a combination of call intake, call dialogue documentation, peer review, case follow-up
• Create and revise training materials based on procedural, system, and regulation updates
• Assume responsibility for quality of data processed

Medical Contact Center Associate II

Sales

• Support meaningful assignments that complement education in STEM+ Business and Healthcare disciplines
• Participate in and execute entry-level department functions in accordance with Fortrea and/or sponsor Standard Operating Procedures (SOPs)
• Support Conga CLM Data Management & Configuration
• Assist with tasks such as picklist value updates, field creation/editing, validation rule troubleshooting, and error administration within Conga CLM
• Engage in structured onboarding through knowledge share, shadowing, and reverse mentoring sessions
• Contribute to Salesforce / Conga CLM Admin Tasks
• Track support work within Conga CLM USRs for traceability and compliance
• Support Training & Process Improvement Initiatives

Apprentice – Salesforce Associate

Marketing

• Assist in planning, executing, and tracking marketing programs, including email campaigns, events, social media, content marketing, and Account-Based Marketing (ABM) initiatives.
• Create and manage purchase orders and support budget tracking for marketing activities.
• Track and support the execution of media plans in collaboration with campaign managers.
• Develop and maintain project management plans, monitor progress, and report on key metrics for marketing initiatives.
• Manage marketing budgets, review processes, and ensure compliance with internal guidelines.
• Oversee vendor relationships, including onboarding, contract management, and performance tracking.
• Apply strong attention to detail, analytical thinking, and problem-solving skills to ensure project success.
• Coordinates marketing events as needed, including proactive communication with vendors and internal stakeholders to ensure alignment and timely execution.
• Communicate effectively through presentations and storytelling to convey project updates and outcomes.
• Prioritize multiple tasks and manage time efficiently in a dynamic environment.
• Perform other duties as assigned.

Marketing Coordinator

• Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements
• Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP
• Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements
• Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems
• Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial
• Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements
• Ensures adherence to global quality control and CRA performance metrics
• Ensures audit readiness at site level
• Acts in the project role of a Lead CRA as assigned

Artificial Intelligence

• Collaborate with global colleagues from Marketing and Commercial
• Support AI/ML projects within the Product Management team
• Participate in remote work during second shift hours
• Assist in project documentation and reporting
• Engage in training and development activities

Apprentice – IT Commercial, AI / ML

Clinical Research

• Lead complex studies such as New Drug Applications submissions or complex, multi-protocol programs
• Perform project management activities for identified projects including resource planning, timelines and milestone management
• Serve as Data Monitoring Committee Support Statistician
• Lead the development of complex Statistical Analysis Plans
• Conduct overall statistical review of Tables, Figures and Listings for complex studies prior to client delivery
• Review Case Report Form and other study specific specifications and plans
• Develop the statistical sections of the protocol for complex studies
• Preparation and review of randomization specifications and generation of randomization schedules
• Provide mentoring and training to less experienced staff
• Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences
• Attend bid defense meetings for complex studies
• Act as Subject Matter Expert and develop or review procedural documents
• Represent the department during audits.

Principal Biostatistician – FSP

• Responsible for project delivery with regards to agreed time, scope, cost, quality, successful outcomes, and project value.
• Serve as key business/client contact for assigned projects, establishing working relationships with business/client project teams which result in business/client satisfaction, operational excellence and thereby increase potential for project ROI or repeat client business.
• Lead core project team(s) and facilitate team's ability to lead extended project team(s), ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders.
• Serve as escalation point for project issues to internal and external stakeholders, as appropriate.
• Proactively identify and resolve conflicts as needed.
• Create, maintain, and manage detailed Project Plans using approved PMO Tools; clearly articulating work breakdown structures of deliverables by phase, activity, and task; with role assignments and estimates to complete on each task.
• Partner with resource managers and functional owners to identify all resources required to execute your plan, negotiate, and place resource requests and manage the resource plan for your projects.
• Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s).
• Create and maintain project accounting records to accurately reflect, by month, by expenditure type and class; project spend-to-date, estimates to complete and estimates at complete; analyzing with explanation any variance between budget, plan, actuals and forecast.
• Deliver project(s) to scope, schedule, and costs, ensuring all remain on track with the contract and with financial performance targets.
• Initiate and implement appropriate actions to proactively manage the change control process both internally and externally.
• Proactively lead both quality control and risk assurance activities to ensure project deliverables are met according to regulatory, and business/client requirements.
• Create and manage variance to required project plans.
• Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs, providing performance feedback to team member’s respective supervisors.
• Ensure that projects are delivered meeting GxP Quality compliance rules and regulations as it applies to IT projects.
• Aid in development and maintenance of key project performance indicators ensuring that the KPIs are within scope of the project charter/contract.
• Define and manage project resource needs and establish succession plans for key resources.
• Ensure that Steering Committee is established for projects and lead or co-lead the meeting with the business to ensure that leadership is kept appraised of status, upcoming activities, dependencies, risks, and roadblocks.
• Develop an understanding of Agile ways of working and Product mindset and assist in moving the organization towards adopting these ways of working.
• In collaboration with relevant departments, support presentations for new projects and client business as required.
• Perform other duties as assigned by management.
• Ensures allocated resources are aligned with current and forecasted work in terms of capability, quantity, timing, and efficiency.
• Provides line management and technical support to assigned project leaders, including training, development, and performance review of assigned staff.

Senior Project Manager – 12 months Contract

Product Manager

• Lead the product life cycle from conception to launch, aligning product vision with customer needs and business goals.
• Conduct market research and analysis to identify trends, opportunities, and competitive threats in the life sciences sector.
• Define and prioritize product requirements, features, and functionalities in collaboration with engineering, sales, and customer support teams.
• Develop and maintain product roadmaps, ensuring clear communication and alignment across all stakeholders.
• Monitor and evaluate product performance metrics, adjusting strategies as necessary to achieve success.
• Foster strong relationships with key clients and industry experts to gather insights and feedback for continuous product improvement.
• Ensure compliance with industry regulations and standards.
• Manages product like a business owner, owning portfolio forecasts, budget management, and driving efficiency into teams and utilization of resourcing including consumption of licenses and 3rd party spend.
• Manage support teams responsible for the Data management incident and problem management processes.

Director of Product Engineering – Data Management

Compliance

• Prepare, compile and review product quality (CMC) and other regulatory documents.
• Create/revise/approve raw material and packaging specifications.
• Coordinate and interact with cross-functional teams for evaluation of change control.
• Support Financial Data Management, Business Plan file creation and maintenance.
• Support for creation and update of global labeling documents.
• Perform literature survey and prepare regulatory documents in support of excipients, APIs and/or drug products.

Regulatory Operations Assistant I

Architect

• Supports the Product Owner, Data Quality, Governance, and MDM in defining the long term technology vision for MDM, and interacting with appropriate vendors and third parties
• Acts as the ARB representative for the MDM Platform.
• Keeps up to date with all key decisions related to canonical data modeling for master data
• Supports the Head of Data Platform Architecture in properly modeling Enterprise Data assets and in the definition, documentation, and maintenance of all architectural standards, policies, and best practices for the MDM platform
• Leads the design of all matching rules for MDM
• Acts as the MDM consultant for cross-program and cross-project technology strategies
• Defines the enterprise MDM Platform technology vision tailored to Fortrea business needs.
• Documents such vision in multiple ways, suited to the interest of different stakeholders and audiences
• Collaborates with all other architects in the data space to ensure a coherent approach to data architecture for Fortrea, builds relationships and works collaboratively with a variety of individuals within the enterprise (IT and Operations), external vendors, and customers alike
• Maintains an up-to-date repository of all technical debt in his/her area
• Works in a lean organization and creatively tackles problems using colleague networks and publicly available solutions; works independently and successfully in a matrix environment; and prioritizes and manages multiple tasks simultaneously
• Works in fast-paced, team-oriented and self-directed entrepreneurial environment

Master Data Management, MDM Architect

Clinical Operations

• Work within the Clinical Operations Team to understand how life-saving medicines begin their journey.
• Join a global team where curiosity, motivation, and fresh ideas are celebrated.
• Assist on meaningful projects and learn from experienced professionals.

Intern University Program – Clinical Operations

Software Engineer

• Perform programming activities for oncology clinical trials, ensuring quality, accuracy, and compliance with study timelines and regulatory standards
• Review SAPs and TFL shells from a programming perspective, providing technical input to optimize oncology analyses
• Advise on the design and development of complex TFL shells and statistical outputs for oncology studies
• Develop and/or lead the creation of specifications for SDTM and ADaM datasets
• Develop and maintain SAS programs to create SDTM and ADaM datasets and generate Tables, Figures, and Listings (TFLs); perform thorough quality control (QC) checks
• Produce and validate Define.xml/PDFs, Analysis Results Metadata (ARM), annotated CRFs, and Reviewers’ Guides to support SDTM and ADaM submissions
• Contribute to the preparation of regulatory submission packages and responses to regulatory and client audits
• Identify, propose, and implement process improvements to enhance programming efficiency, quality, and standardization
• Stay up to date on industry standards, global regulatory requirements, Fortrea SOPs, and CDISC developments relevant to oncology data.

Senior Statistical Programmer – Oncology

Technical Project Manager

• Responsible for project delivery with regards to agreed time, scope, cost, quality, successful outcomes, and project value.
• Serve as key business/client contact for assigned projects, establishing working relationships with business/client project teams which result in business/client satisfaction, operational excellence and thereby increase potential for project ROI or repeat client business.
• Lead core project team(s) and facilitate team's ability to lead extended project team(s), ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders.
• Serve as escalation point for project issues to internal and external stakeholders, as appropriate.
• Proactively identify and resolve conflicts as needed.
• Create, maintain, and manage detailed Project Plans using approved PMO Tools; clearly articulating work breakdown structures of deliverables by phase, activity, and task; with role assignments and estimates to complete on each task.
• Partner with resource managers and functional owners to identify all resources required to execute your plan, negotiate, and place resource requests and manage the resource plan for your projects
• Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s).
• Create and maintain project accounting records to accurately reflect, by month, by expenditure type and class; project spend-to-date, estimates to complete and estimates at complete; analyzing with explanation any variance between budget, plan, actuals and forecast.
• Deliver project(s) to scope, schedule, and costs, ensuring all remain on track with the contract and with financial performance targets.
• Initiate and implement appropriate actions to proactively manage the change control process both internally and externally.
• Proactively lead both quality control and risk assurance activities to ensure project deliverables are met according to regulatory, and business/client requirements.
• Create and manage variance to required project plans. Per SOPs, implement and monitor progress against project plans and revise as necessary.
• Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs, providing performance feedback to team member’s respective supervisors.
• Ensure that projects are delivered meeting GxP Quality compliance rules and regulations as it applies to IT projects.
• Aid in development and maintenance of key project performance indicators ensuring that the KPIs are within scope of the project charter/contract.
• Define and manage project resource needs and establish succession plans for key resources.
• Ensure that Steering Committee is established for projects and lead or co-lead the meeting with the business to ensure that leadership is kept appraised of status, upcoming activities, dependencies, risks, and roadblocks.
• Develop an understanding of Agile ways of working and Product mindset and assist in moving the organization towards adopting these ways of working.

Senior IT Project Manager – Contract

• Supporting the planning, execution, and oversight of clinical trials
• Assisting in the preparation, review, and maintenance of clinical trial documents (e.g., protocols, informed consent forms, case report forms)
• Supporting communication and coordination with clinical trial sites
• Participating in data entry, tracking, and quality control activities
• Helping prepare materials for regulatory submissions and ensuring compliance with applicable guidelines
• Monitoring study progress, including enrollment tracking and visit schedules
• Supporting statistical programming tasks such as data cleaning, validation, and generation of summary outputs
• Assisting in the development and testing of data management tools and electronic data capture systems
• Conducting literature reviews and summarizing findings relevant to ongoing studies
• Performing administrative tasks to support the assigned team
• Supporting internal audits or inspections readiness activities

• Assist the Regulatory Consulting team in the development and analysis of client project deliverables
• Research emerging trends, and regulatory frameworks to support client solutions
• Collaborate on projects involving regulatory strategy design for product development, patient access, and market entry
• Contribute to data analysis, reporting, and presentation development for clients and leadership teams
• Support internal project management tasks, including documentation, meeting coordination, and solution tracking

Regulatory Strategy Intern

• The manager of data integrations works with delivery teams to plan the smooth deployment of integration features and releases
• The work with service providers to review issues, service requests service levels for the smooth flow of clinical data across Fortrea and with our clients
• Responsible for managing vendor delivery of issue resolutions and solution enhancements
• Understand IT & business needs and ensure integrations meet those needs, ensure all technology solutions align with IT technical strategy and overall Fortrea architecture roadmap while adhering to organization standards.
• Translate business and technical requirements into integration implementation.
• Provide technical guidance on solution design during planning phase, with a view on support and operations and ensure technical excellence in issue resolution
• Diagnose complex issues and provide solutions when unit testing and integrations fail to meet specifications.
• Translate knowledge of software and compliance regulations into software development/maintenance guidelines and standards
• Partner with project teams and provide suggestions or recommendations on design and/or process improvement.
• Promote adherence to compliance and documenting changes
• Ensure extensive testing and verification of test results during integration testing with other systems; Identify implementation risks and potential impacts; troubleshoot system errors and serve as a resource to others in the resolution of complex errors.
• Own delivery of test plans, technical and functional specifications.
• Administer integration platform, monitor, secure REST/SOAP services, and manage API traffic flow, etc.
• Track integration trends and relate these to planning current and future integrations needs.

Senior Manager, Integration – Azure

• Develop accurate and comprehensive investigator grant estimates for clinical research studies
• Oversee and develop RFP budgets in alignment with project goals and company standards
• Analyze historical data to benchmark costs and ensure accuracy of estimates
• Ensure compliance with sponsor specifications and RFP requirements
• Lead budget development in response to requests for proposals and manage end-to-end budget process

Proposal and Grants Manager I

Analyst

• Lead and execute with full ownership of the assigned RWE projects.
• Provide programming support for the analysis of real-world data across diverse sources including medical and pharmacy claims data.
• Develop and validate analysis datasets from various file formats and sources.
• Validate and develop graphs and tables for exploratory investigations.
• Ensure excellence in the programming of analysis-ready datasets and figures.
• Develop and maintain required documentation for the deliverables.
• Communicate accurate and timely status updates to project team members.
• Mentor less-experienced RWE analysts.
• Respond to QA and client audits.

Lead Analyst, Real World Evidence

Medical Director

• Provide medical direction for the conduct of early clinical trials
• Support the development activities of proposed and ongoing projects in their area of expertise
• Provide oversight of medical monitoring activities to ensure timelines and quality of medical deliverables
• Assign physician resources as required
• May serve as Global, Regional or Program Lead Project Physician across multiple indications
• Provide subject matter and drug development expertise and is a key contributor to the medical strategy and execution of the study/program for the client
• Provide input, review and revision of protocols, case report forms, training materials, project specific tools, analysis plans design, clinical trial reports and new drug applications.
• Prepare materials for and actively participate in investigator meetings and assist at site initiation visits
• Provide medical/scientific expertise to project team.

Medical Director, Senior Medical Director – Ophthalmology

QA Engineer

• Define and execute the Quality System that regulates Fortrea Clinical Services
• Develop and implement a global QA strategy aligned with corporate goals and regulatory expectations
• Ensure adherence to global regulations through the creation and completion of a strong quality risk framework of annual audits.
• Represent Regulatory Compliance & Quality Assurance on all potential mergers/acquisitions, along with the subsequent integrations of the target entity.
• Serve as a key member of the extended leadership team, contributing to overall business strategy and risk management
• Partner with the business leaders to implement and oversee the quality system, ensuring a collaborative approach to driving a strong culture of quality.
• Develop proactive measures to mitigate quality-related risks and maintain compliance with global regulatory bodies with the Fortrea Clinical Services business leaders
• Identify and implement continuous improvement initiatives to enhance operational and QA efficiency and reduce risks
• Build, lead, and mentor a high-performing global QA team
• Oversee the QA team to serve as the primary contact in regulatory inspections and audits of Fortrea
• Establish Key Quality Metrics/Indicators, analyze trends, and report findings to executive leadership for informed decision-making

Global Head – Clinical Services, Regulatory Compliance & QA

• Perform programming activities for oncology clinical trials, ensuring quality, accuracy, and compliance with study timelines and regulatory standards
• Review SAPs and TFL shells from a programming perspective, providing technical input to optimize oncology analyses
• Advise on the design and development of complex TFL shells and statistical outputs for oncology studies
• Develop and/or lead the creation of specifications for SDTM and ADaM datasets
• Develop and maintain SAS programs to create SDTM and ADaM datasets and generate Tables, Figures, and Listings (TFLs); perform thorough quality control (QC) checks
• Produce and validate Define.xml/PDFs, Analysis Results Metadata (ARM), annotated CRFs, and Reviewers’ Guides to support SDTM and ADaM submissions
• Contribute to the preparation of regulatory submission packages and responses to regulatory and client audits
• Identify, propose, and implement process improvements to enhance programming efficiency, quality, and standardization

Senior/Principal Statistical Programmer – Oncology

• Execute study-related administrative tasks for Clinical Project Teams to ensure timely production of high quality clinical data.
• Document and track study activities using relevant forms, tools and Project Management Systems.
• Prepare study and site-specific materials in accordance with SOPs.
• Take minutes and document sponsor/external or internal teleconferences as requested.
• Create and maintain tracking systems/spreadsheets (study supplies, CTMS contact lists) and maintain the Project Directory.
• Provide support for Investigator Meetings and general project team administrative support (proof-reading, mailings, shipment of study files, assemble documents, arrange meetings).
• Maintain Trial Master File documentation within TMF platform; participate in TMF QC, tracking and archiving as applicable.
• Audit and CAPA tracking; set up and maintain clinical investigator files and documentation.
• Liaise with vendors for study conduct, coordinate and plan study supply shipments, confirm courier tracking and delivery information.
• Train and mentor less experienced Clinical Trial Administrators; may serve as Lead CTA on projects.