Fortrea

Clinical Research

• Responsible for the full cycle of Clinical Data Management queries
• Cooperate with Clinical Data Managers, Data Coordinators, Statistical Programmers and others
• Assist and lead operations alongside Senior CDM
• Develop project documentation, system setup, data validation processes and procedures assigned to junior staff
• Work with Senior CDM to build study milestone timelines and follow study timelines for on-time deliverables
• Assist or lead internal and external DM meetings
• Manage proactively risks and resolve or escalate issues connected to Clinical Data Management improvement or technology
• Develop understanding of CDASH and SDTM or other recognized industry standards and their impact on programming teams
• Specialize in TA-specific data capture and standards, conduct lessons learned and disseminate them across the organization
• May act as a team leader or mentor Clinical Data Management colleagues and stakeholders on operational processes
• Lead project-level activities consistent with current or previous experience in support of study delivery

Associate Clinical Data Manager – FSP

• Identify and assess new potential investigators and sites
• Recommend sites during feasibility and selection phases
• Conduct pre-study, initiation, monitoring, and close-out visits
• Monitor site performance, data quality, and protocol compliance
• Act as a key point of contact for site personnel, providing training and support
• Use data insights to assess risks and drive decisions
• Support regulatory audits, EC submissions, and system access coordination

Clinical Research Associate – DACH

Medical Director

• Provide medical direction for the conduct of clinical trials
• Support development activities for proposed and ongoing projects in the relevant area of expertise
• Perform medical monitoring for assigned clinical studies
• Drive projects from an overall company perspective beyond the medical perspective
• Provide strategic and tactical subject matter expertise for client proposals, bid defenses, business development, quality/process improvement and audit activities
• Contribute to company policies involving medical, safety and therapeutics
• Provide cross-functional scientific and technical contributions and interact with client medical teams, project teams, key opinion leaders and investigators/sites
• Partner with GCO to develop new and enhance existing client relationships
• Participate in proposal teams and provide medical/scientific capabilities to clients and internal teams
• Perform site/investigator feasibility and build investigator relationships to support recruiting and trial conduct
• Interact with study teams, functional groups, investigational sites, regulatory authorities, ethics committees, safety monitoring boards and healthcare professionals
• Support and participate in departmental recruitment
• Provide leadership and present medical/scientific capabilities to clients
• Manage, supervise and delegate activities to up to 5–10 direct and indirect reports as applicable
• Serve as Global, Regional or Program Lead Project Physician across multiple indications as assigned
• Provide drug development expertise and contribute to medical strategy and study/program execution
• Review and revise protocols, case report forms, training materials, project tools, analysis plans, clinical trial reports, data tables, listings, figures and new drug applications
• Prepare materials for and participate in investigator meetings and assist at site initiation visits
• Provide medical and scientific expertise to project teams
• Conduct medical and safety monitoring and participate in project risk assessment
• Perform medical data review and oversee central medical data review where applicable
• Review and act upon safety alerts as required
• Support medical review of coding
• Assist with data safety monitoring board activities
• Review medical monitoring scope of work, hours and budgets
• Oversee medical monitoring activities, timelines and quality of deliverables, assigning physician resources as required
• Maintain subject matter expertise through CME, clinical work and relevant conferences/meetings
• Develop training modules and provide disease-area and protocol-specific training
• Participate in process improvement activities
• Represent the company at conferences and scientific meetings
• Lead therapeutic-area initiatives involving physicians across the therapeutic area
• Perform other duties as assigned

Senior Medical Director – MD

On Call

• Handle inbound and outbound calls with individuals interested in participating in clinical research studies
• Explain study opportunities and provide participants with relevant study information
• Conduct initial phone screenings using study-specific scripts and guidelines
• Collect and accurately enter participant demographic and medical history information into computerized systems
• Schedule qualified participants for screening appointments
• Confirm upcoming screening appointments and communicate next steps
• Respond professionally to participant questions and inquiries
• Work closely with the screening team to coordinate participant recruitment activities and required information
• Maintain a high degree of accuracy, professionalism, confidentiality, and customer service
• Identify opportunities to improve recruitment and participant communication processes
• Perform other recruitment-related responsibilities as needed

Clinical Call Representative – On-call

Clinical Operations

• Execute and oversee local operational clinical trial activities at the country level
• Own and oversee local regulatory and financial compliance
• Deliver country-specific trial commitments and objectives, especially during study start-up
• Influence investigators, vendors, external partners, and country managers to meet commitments
• Adhere to budget targets and payment timelines
• Address and resolve issues locally
• Maintain expertise in country-based regulations, laws, and procedures
• Support budget and contract negotiations
• Manage local ethics, legislation, regulatory environment, submission and approval processes
• Develop local-language informed consents and other site-ready and ongoing study deliverables
• Develop risk management and mitigation plans
• Assist with country and site budgets and deliver clinical and financial contracts
• Oversee and track clinical research-related payments and reconcile payments at study close-out
• Execute and oversee country submissions and approvals for assigned protocols
• Work with IRB/IEC and Regulatory Authorities on submission and approval interactions
• Manage country deliverables, timelines, and results for assigned protocols
• Contribute to local SOP development
• Collaborate with clinical operations, quality, finance, medical, regulatory, pharmacovigilance, compliance, legal, regional, vendor, site, IRB/IEC, and regulatory teams
• Align country timelines with Regional Operations and oversee local vendors
• Manage clinical and ancillary supplies, import/export requirements, supplies destruction, filing, archiving, retention, and insurance processes
• Enter and update country information in clinical, regulatory, safety, and finance systems
• Perform other assigned duties

Clinical Operations Manager

• Perform all aspects of study site monitoring, including routine monitoring and close-out of clinical sites
• Maintain study files and conduct pre-study and initiation visits
• Liaise with vendors and manage sites according to project plans
• Ensure study staff receive proper materials and instructions
• Verify informed consent procedures and protocol compliance
• Monitor source documents and data for missing or implausible information
• Manage clinical study registries and undertake feasibility work
• Complete Serious Adverse Event reporting, narratives, and follow-up
• Perform CRF review and query generation and resolution using Fortrea or client data management systems
• Assist with training new employees through co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator
• Act as a local client contact when assigned
• Perform other duties assigned by management

Clinical Research Associate 2 – Oncology

• Provide a high standard of care for participants in clinical trials and respond to emergency situations based on clinical research standards
• Conduct routine monitoring and close-out of clinical sites
• Maintain study files
• Conduct pre-study and initiation visits
• Liaise with vendors
• Manage study sites according to project plans
• Ensure study staff receive proper materials and instructions to safely enroll patients
• Verify informed consent procedures and protocol requirements comply with applicable regulations
• Ensure integrity of Case Report Form and other collected data through source-document monitoring
• Monitor data for missing or implausible information
• Manage registries according to project plans and undertake feasibility work when requested
• Complete Serious Adverse Event reporting, reports, narratives, and follow-up
• Perform CRF review and generate and resolve queries using Fortrea or client data management systems
• Assist with training new employees through activities such as co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator, with supervision if applicable
• Act as a local client contact when assigned
• Perform other duties assigned by management
• Travel frequently to client and site locations, including occasional domestic and international travel

• Provide a high standard of care for participants in clinical trials and respond to emergency situations according to clinical research standards
• Perform routine monitoring and close-out of clinical sites
• Maintain study files
• Conduct pre-study and initiation visits
• Liaise with vendors
• Manage study sites according to project plans
• Ensure study staff receive proper materials and instructions
• Verify informed consent procedures and protocol requirements comply with applicable regulations
• Verify data integrity in Case Report Forms and other data collection tools
• Monitor data for missing or implausible information
• Manage registries and undertake feasibility work when requested
• Complete Serious Adverse Event reporting, reports, narratives, and follow-up
• Perform CRF review, query generation, and resolution using Fortrea or client data management systems
• Assist with training new employees through activities such as co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator
• Act as a local client contact when assigned
• Travel frequently to client and site locations, including occasional domestic and international travel
• Perform other duties assigned by management

• Provide a high standard of care for participants in oncology clinical trials and respond to emergency situations based on clinical research standards
• Conduct routine monitoring and close-out of clinical sites
• Maintain study files and conduct pre-study and initiation visits
• Liaise with vendors and perform other assigned duties
• Manage study sites according to project plans
• Ensure study staff receive proper materials and instructions
• Verify informed consent procedures and protocol requirements comply with applicable regulations
• Ensure the integrity of submitted Case Report Forms and other data collection tools through source-document review
• Monitor data for missing or implausible information
• Manage registries and undertake feasibility work when requested
• Complete Serious Adverse Event reporting, reports, narratives, and follow-up
• Perform CRF review, generate and resolve queries using Fortrea or client data management systems
• Assist with training new employees through activities such as co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator and may act as a local client contact
• Travel frequently to client and site locations, including occasional domestic and international travel

Senior Clinical Research Associate II - Oncology

Auditor

• Assist in planning and executing operational, financial, compliance, and SOX audits according to the annual audit plan
• Perform process walkthroughs to understand business activities, identify key risks, and document internal control environments
• Execute key-control testing and substantive audit procedures to evaluate design and operating effectiveness
• Prepare audit workpapers documenting procedures, evidence, and conclusions
• Analyze process and transactional data to identify trends, anomalies, control gaps, and improvement opportunities
• Support development of audit observations and practical recommendations
• Partner with business stakeholders to obtain information, discuss audit results, and resolve identified issues
• Track management action plans and validate remediation efforts
• Support SOX compliance activities, including risk assessments, walkthroughs, control testing, deficiency evaluation, and documentation
• Participate in special projects, investigations, advisory engagements, and risk-focused reviews
• Enhance audit methodologies, templates, and tools
• Monitor emerging risks, industry practices, regulatory requirements, and internal audit standards

Internal Auditor, Finance

Project Manager

• Work with the project team to set up and maintain project schedules; update timelines in MS Project, CTMS, project governance tools, and other trackers; escalate timeline risks
• Assist the Project Lead with timesheet-versus-budget reviews, vendor financial tracking and reconciliation, sponsor contract financial tracking and reconciliation, and final project financial reconciliation
• Conduct Contract versus Study Plan Reviews with the Project Lead; maintain out-of-scope work trackers; assist with Change Order Forms; provide vendor management and escalate out-of-scope activities
• Update the Xcellerate Risk Identification and Issue Resolution (RIIM) tool and follow action items through resolution
• Complete the Xcellerate Risk Assessment Categorization Tool (RACT) using the Xcellerate Risk library
• Ensure Protocol Deviations are updated in Xcellerate RIIM
• Update the Project Governance Tool monthly
• Support identification, prevention, and closure of quality compliance gaps
• Support audit and investigation preparation, including creation of issue storyboards
• Support timely closure of audit/inspection CAPAs
• Facilitate study team communication and collaboration through meetings, ADI logs, Task Order Matrix, Project Directory, distribution lists, SP sites, mailboxes, collaboration tools, and project-specific trackers
• Collaborate with support functions on TMF uploading, TMF reviews, TMF issue resolution, systems access, project-specific training curricula, and delegated tasks
• Monitor, escalate, and help enforce redaction of subject-sensitive information and identifiers in study documentation
• Maintain the Lessons Learned tracker with the Study Team
• Perform other duties as needed or assigned

Project Coordinator

General

• Serve as primary contact with investigative sites during study start-up and maintenance
• Collect, organize, quality-review, format, compile, and file investigator and essential study documents
• Coordinate EC/IRB/Third body/Regulatory Authority applications and submissions within agreed timelines
• Prepare country application forms, cover letters, and routine submissions such as INDs/CTAs
• Liaise with regulatory authorities, internal teams, external vendors, and investigative sites
• Review final submission documents and ensure compliance with regulations, ICH/GCP, SOPs, quality standards, budgets, and client expectations
• Track start-up, maintenance, site activation, contract, and budget activities and milestones
• Identify, prevent, and escalate study issues and risks to deliverables
• Maintain systems and documentation in an audit-ready state
• Participate in team and project meetings
• Assist with site activation strategy, projections, and timelines
• Review and customize country- and site-specific informed consent forms
• Support negotiation and tracking of site contracts and budgets when applicable
• Mentor and train new hires and less-experienced colleagues when suitable
• Perform other duties as assigned

Start-up Specialist

• Lead a global team of project management professionals
• Oversee operational delivery, financial performance, quality outcomes, and client satisfaction for the RWE and Phase IV project management portfolio
• Drive business growth, portfolio profitability, delivery excellence, strategic resourcing, and cross-functional collaboration
• Manage the RWE and Phase IV project management P&L and achieve financial objectives, including profitable growth and market expansion
• Monitor research operations performance against client satisfaction, quality, and financial KPIs
• Drive competitive pricing through right-fit resourcing models
• Partner with Proposals, Commercial, and Finance leadership on budget tools, bid and pricing reviews, resourcing, and delivery strategies
• Build and develop a high-performing leadership team, including talent development and succession planning
• Promote financial stewardship, budget management, forecasting, and delivery excellence among project managers
• Partner with senior leaders in Clinical Operations, Commercial, Finance, Quality, and other functions
• Oversee quality, performance, and success of projects across the portfolio
• Embed risk management practices and implement project tools, templates, and performance reporting
• Drive high client satisfaction, repeat business, and portfolio expansion
• Identify and direct department and company initiatives
• Support bid defenses, portfolio planning, and strategic accounts
• Report to the VP of RWE and Phase IV Studies
• Travel to client meetings, sites, company businesses, and training events as needed

Executive Director, Project Management – RWE & Phase IV Studies

Business Development Rep

• Lead the execution of the overall business development strategy to support long-term growth and profitability
• Collaborate with senior leadership to align business development objectives with corporate goals
• Develop and maintain strategic account plans and partnerships with key accounts
• Analyze market trends, customer needs, and competitive intelligence to identify new business opportunities
• Identify, evaluate, and prioritize high-impact opportunities and strategic partnerships
• Achieve or exceed annual sales plans and sales targets for assigned accounts
• Assign accounts and territories and establish individual territory sales goals
• Support the sales team in cultivating internal and external relationships and identifying new market opportunities
• Collaborate with sales leaders in other business units to develop joint opportunities and client relationships
• Lead margin and pricing negotiations
• Facilitate internal relationships and communication with operational colleagues
• Contribute to global MSAs and preferred provider agreements
• Establish and monitor performance goals for the business development team
• Oversee pipeline management, forecasting, and analysis of key sales metrics
• Lead, coach, and mentor Business Development Directors
• Troubleshoot and resolve internal and external issues and remove barriers to success
• Perform other duties as assigned

Executive Director, Business Development – Early Phase

• Provide medical leadership and strategic support while partnering with clients and cross-functional teams
• Strengthen relationships and drive successful clinical development programs
• Provide oversight, mentorship, and guidance to team members
• Contribute to Global Clinical Operations initiatives
• Contribute to Company policies involving medical, safety, and therapeutics
• Participate in Company-wide process improvement activities
• Lead staff within the therapeutic area
• Lead initiatives involving physicians within and across the therapeutic area
• Contribute to the vision and strategic direction of the therapeutic area
• Develop training modules and materials and provide disease-state and protocol-specific training
• Participate in training on drug development and Good Clinical Practice guidelines
• Provide drug development expertise to medical strategy and execution of client programs
• Develop, review, and revise protocols, case report forms, training materials, project-specific tools, analysis plan designs, clinical trial reports, and new drug applications
• Provide medical and scientific expertise to project teams
• Act as Medical Monitor/study support for early clinical trials
• Perform medical and safety monitoring on assigned projects
• Interact with interdepartmental teams and external consultants
• Participate in feasibility discussions for project proposals
• Participate in project risk assessment activities
• Assist with Data Safety Monitoring Board activities when needed
• Provide clinical and medical expertise to other Fortrea departments
• Contribute to scientific and strategic leadership of a therapeutic area
• Perform other assigned duties and responsibilities

Associate Clinical Data Manager – FSP

Clinical Research Associate – DACH

Senior Medical Director – MD

Clinical Call Representative – On-call

Clinical Operations Manager

Clinical Research Associate 2 – Oncology

Clinical Research Associate 2 – Oncology

Clinical Research Associate 2 – Oncology

Senior Clinical Research Associate II - Oncology

Internal Auditor, Finance

Project Coordinator

Start-up Specialist

Executive Director, Project Management – RWE & Phase IV Studies

Executive Director, Business Development – Early Phase

Senior Medical Director, MD