Fortrea

Role Description Fortrea is looking for an experienced Contract and Budget Lead to support our key client in EMEA. - Manage escalations and review of assigned site budgets and contracts to ensure timely contract execution and study startup forecasts are achieved. - Support the development of creative processes, methodologies, data, and technologies that will ensure ongoing improvements in the service delivery. Responsibilities: - Responsible for assigned country level SB&C function to develop, negotiate, administrate and execute assigned Clinical Trial Agreements and budgets. - Oversight of assigned country budget setup including parameters development. - Partner with Study Startup, SB&C team and Clinical Operations teams as an escalation point for global budget escalations outside of budget parameters. - Leverage leading industry tools and data sources to provide budget and contract feedback aligned with company parameters and fair market value guidance. - Promptly recognize and improve potential delays providing solutions to resolve and escalate non-performance. - Manage site contracts and budgets negotiation timelines to ensure sites are "Ready To Enroll" to the Startup Project Plan. Qualifications - BS degree or international equivalent. - 4 or more years of experience in clinical research site contracting and budgeting, including country budget build with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor. - At least 2 years of site budgeting and contracting oversight. - Ability to explain data, facilitate decision making processes to be data driven. - Expertise in principles driving country/site budgeting and contracting strategies. - Excellent organizational skills, decision making, communication and negotiation skills. Requirements - BS degree or international equivalent. - 4 or more years of experience in clinical research site contracting and budgeting, including country budget build with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor. - At least 2 years of site budgeting and contracting oversight. - Ability to explain data, facilitate decision making processes to be data driven. - Expertise in principles driving country/site budgeting and contracting strategies. - Excellent organizational skills, decision making, communication and negotiation skills. Company Description

Role Description We’re now hiring a Study Start-Up Lead to join a sponsor‑dedicated team and drive the successful planning and activation of clinical trials. If you are passionate about accelerating study timelines, using data to guide decisions, and mentoring study start-up teams — this role offers you the opportunity to create a real impact. Your Main Responsibilities: - Lead, guide, and empower site activation teams across multiple countries. - Partner closely with Clinical Operations to improve study start-up metrics and implement optimized processes. - Provide leadership, oversight, and mentoring to the FSP Site Start-Up team supporting global clinical programs. - Develop and refine data-driven forecasting models, planning scenarios, and benchmarking tools. - Create country-specific Informed Consent Forms (ICFs) based on master templates and local requirements. - Ensure SSU standards are applied consistently across projects and support ongoing process improvements. - Lead data collection and analysis to influence SSU timelines and strategic decisions. - Use leading industry data sources and tools to support forecasting, site readiness insights, and cycle-time optimization. - Agree on site-level deliverables with internal teams; identify delays early and escalate when needed. - Drive delivery of “Ready to Enroll” status for both sponsor and CRO-supported sites. - Serve as the escalation point for site activation challenges, partnering with Study Managers to resolve issues. Qualifications - Bachelor’s degree in Life Sciences (or international equivalent). - 4+ years of experience in clinical operations, project management, SSU, or trial optimization. - 2+ years directly managing site activation and study start-up processes within a sponsor or CRO. - Proven experience with country-level ICF creation. - Strong proficiency with data models, forecasting tools, and database structures. - Experience working in global site start-up environments strongly preferred. - Ability to explain complex data clearly and support data-driven decision-making. - Expert understanding of factors that drive successful study start-up and site selection strategies. Benefits - Work in a collaborative, global environment with experts passionate about improving clinical research. - Influence data-driven study start-up strategies for large-scale international programs. - Play a key role in optimizing processes, bringing fresh ideas, and driving continuous improvement. Company Description At Fortrea, we believe in improving lives through the power of science, collaboration, and innovation. As a global CRO partner, we support mission-driven sponsors in bringing new therapies to the patients who need them.

• Develop Clinical Trial Agreements (CTAs) utilizing standard templates • Ensure CTAs are executed timely • Liaise with legal departments for content changes • Participate in Study kick-off meetings • Generate site budgets based on final approved country budget • Manage CTAs ensuring changes are updated • Responsible for internal approval forms and compliance • Ensure communication among trial site personnel • Negotiate Master Services Agreements (MSAs) with Institutions • Support Country Study site budget template, parameter, and payment term building

• Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines. • Ability to organize and effectively prioritize workload and deliverables. • As the Study Manager, be accountable for all DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest quality, while adjusting resource allocations accordingly. • Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs. • Work with the Project Manager(s) or FSP Lead (or designee) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings. • Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of EDC Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager or FSP Lead (or designee) apprised of project progress. • Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on DM resources or deliverables and consult with Project Manager (or designee) and/or functional group management as necessary.

Role Description Service Delivery, People Services Center contact, receives inquiries on service central and provides employee support. Performs workload fulfillment for Service Delivery activities and enters information into administration and tracking systems. - Service Delivery, People Service Center contact (w/administrative experience). - May deliver regional administrative support for HR activities (e.g., Personnel files, On/Off boarding). - Receives inquiries on service central and may serve as regional point of contact for manager/employee inquiries. - Workload fulfillment for Service Delivery activities (e.g., HR invoices, Offer administration, and employee services). - Entry of information into administration and tracking systems (e.g., Workday, Service Now). - Accountable to service delivery performance/satisfaction measures, expectations, and standards (qualitative/quantitative). - May include HR Admin work unique to business or site/geography. - May include Local liaison between business and Service Delivery, People Services Center. - May include support to Local Managers, Employees, HR. - Provide administrative support for HR responsibilities that must be handled locally (employee records, On/Off boarding), as needed depending on size and scope of the site. - Requires unquestionable customer service skills, organization, and confidentiality. - Limited Knowledge of HR administrative procedures, organization programs, policies, and practices. - Limited Knowledge of HR systems (Service central, HRMS, LMS). - Ability to solve problems with minimal guidance. - Must be flexible and willing to assist others as needed in a team environment. - All other duties as needed or assigned. Qualifications - Degree, or equivalent combination of education, training, and work experience. - AA accepted w/ Experience or HR focus. - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. - Language Skills Required: - Speaking: Minimal = English written and verbal. Depending on location may require second language skills. - Writing/Reading: Minimal = English written and verbal. Depending on location may require second language skills. Requirements - 0-1+ years of HR experience and related systems. - Demonstrated ability to gain knowledge of HR disciplines and processes as well as business operations. - Must be customer-focused and comfortable working with a diverse group of people. - Good relationship management skills. - Familiar with MS Office suite, particularly Excel, PowerPoint, and Word. Preferred Qualifications Include - Customer focus: ability to resolve issues. - Effective collaboration with others to implement solutions to problems. - Effective communications skills and able to explain processes and procedures. - Ability to execute on assignments and priorities. - Ability to work within data management systems. - Demonstrated skills using Microsoft applications (e.g., Excel, Word, Visio, PowerPoint); and capable of maintaining confidentiality at all times. Physical Demands/Work Environment - Home/Office Environment. - Ability to work globally and in a virtual environment; Requires some flexibility in scheduling work hours. - Travel is required as and when there is a business requirement.

• The Director/Senior Director, Participant Recruitment & Engagement is responsible for the strategic leadership, development, and execution of participant recruitment, engagement, and retention initiatives that support clinical trial enrollment objectives across Clinical Pharmacology Services. • Lead the creation and optimization of multi-channel participant acquisition campaigns, including digital marketing, social media, referral programs, community outreach, database re-engagement, and strategic partnerships. • Collaborate with internal and external stakeholders to develop participant-centric marketing initiatives that increase awareness, engagement, and conversion. • Ensure recruitment strategies are tailored to target participant populations and aligned with protocol requirements and site capacity needs. • Establish best practices for participant communications, brand messaging, and recruitment campaign execution. • Develop participant engagement and retention strategies that improve conversion rates, participant satisfaction, and study completion rates. • Drive initiatives focused on enhancing the overall participant journey from initial inquiry through study completion. • Analyze key performance indicators, including lead generation, conversion rates, enrollment metrics, retention metrics, cost-per-enrollment, and campaign ROI. • Evaluate and implement innovative recruitment technologies and marketing solutions to strengthen participant outreach and engagement efforts.

Role Description Lead writer independently responsible for the preparation of clinical study protocols and clinical study reports (CSRs), and other documents as needed for lower complexity studies. Provides support to more experienced writers with the preparation of clinical study protocols and CSRs, and other clinical documents as needed. Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate. Responsible for preparation and review of clinical documents such as patient safety narratives and CSR appendices. Ensure timely delivery of high-quality documents to internal customers and Sponsors. Provision of training for Associate Medical Writers and other staff as appropriate. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. - Independently prepare lower complexity protocols and CSRs including interpretation of clinical data and statistical results as appropriate. - Work with more experienced colleagues in the development of higher complexity protocols and CSRs, and other clinical documents as needed. - Independently prepare and review patient safety narratives. - Provide support and project management of narrative projects. - Prepare and/or oversee compilation of CSR appendices. - Prepare documents in accordance with Fortrea/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines. - Independently review Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) for assigned studies to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed. - Incorporate internal and/or external review comments on clinical documentation. - Communicate with internal/external clients as needed to facilitate achievement of project goals. - Participate in meetings with internal and external clients, with guidance and support from colleagues. - Lead meetings as appropriate. - Responsible for project coordination and adherence to project timelines and budget, as appropriate. - Represent department in inter-department working groups. - Provide training and guidance to Associate Medical Writers and other staff as appropriate. - Comply with Fortrea internal processes and procedures. - Performs other duties as assigned by Management. Qualifications - First degree in life sciences (or equivalent). - Advanced degree (e.g., PhD or Masters) preferred. Requirements - Typically, minimum 1 years medical writing experience or 2 years professionally-related experience. - Excellent command of written and spoken English. - Good written and verbal communication skills. - In-depth knowledge of MS Word. - Good organizational and time management ability. - Excellent interpersonal skills. - Scientific or Clinical research experience desirable. - Good scientific writing skills. - Understanding of medical, pharmacokinetic, and statistical principles. Physical Demands/Work Environment - Office environment.

Role Description Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing settings (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as a stand-alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary of Responsibilities - Assist in the processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to: - Maintenance of adverse event tracking systems. - Set-up and maintenance of project files, and central files for documentation. - Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines. - Ensure all incoming Adverse Event (AE)/ Serious Adverse Event (SAE) reports are appropriately logged into the departmental tracking application and forwarded to the centralized mailbox. - Assist with processing of the adverse events, including but not limited to: - Data entry of safety data onto adverse event tracking systems. - Write patient narratives and code adverse events accurately using MedDRA (for Marketed products, if applicable). - Assist in the listedness assessment against appropriate label (for Marketed products, if applicable). - Generate queries for its collection of missing or discrepant information in consultation with medical staff, if needed. - Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines. - Maintenance of adverse event tracking systems. - Assist with peer/quality review of processed reports and support with trends and actions as needed. - Assist in the reconciliation of databases, as applicable. - Assist in the maintenance of files regarding adverse event reporting requirements in all countries. - Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate. - Prepare and support coordination of safety study files for archiving at completion of projects. - Arrange and schedule internal and/or external meetings/teleconferences. - Train and mentor the PSS Assistants or peers in their day-to-day activities. - Build and maintain good PSS relationships across functional units. - Ensure compliance of operations with governing regulatory requirements and applicable study/project specific plans. - Assume responsibility for quality of data processed. - Provide administrative support to PSS personnel. - All other duties as needed or assigned. Qualifications - Non-Degree or 1-2 years of Safety experience* or relevant experience** - Associate degree or 6 months to 1 year of Safety experience* or relevant experience** - BS/BA with 0-6 months to 1 year of Safety experience* or relevant experience** - MS/MA with 0-6 months of Safety experience* or relevant experience** - PharmD with 0-6 months of Safety experience* or relevant experience** - For PharmD, a one-year residency or fellowship can be considered as relevant experience. To be considered in lieu of experience, Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area. Requirements - Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. - Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance. - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. - Speaking: English and local language. - Writing/Reading: English and local language. Experience - Good team player and offer peer support as needed. - Ability to set priorities and handle multiple tasks. - Attention to detail. - Good written and verbal communication skills. - Logical and spelling skills, preferably with an aptitude for handling and proof-reading numerical data. - Good keyboard skills, preferably with knowledge of MS Office and Windows would be beneficial. - Ability to operate standard office equipment. Physical Demands/Work Environment - Office Environment or remote.

• Perform Lead Biostatistician role on medium complexity studies, providing statistical oversight and attending relevant project meetings. • Perform project management activities for identified projects including resource planning, timelines, and milestone management. • Preparation of Statistical Analysis Plans (including mock TFL shells) for medium complexity studies under the supervision of more senior statistical staff. • Perform complex statistical analyses, quality check statistical analyses developed by other statisticians. • Conduct overall statistical review of TFLs for complex studies prior to client delivery. • Review CRF and other study specific specifications and plans. • May perform sample size calculation for simple studies under the supervision of more senior statistical staff. • Develop the statistical sections of the protocol for simple to medium complexity studies under the supervision of a statistical consultant. • Provide statistical input and review of the CSR for medium complexity studies. • Preparation and review of randomization specifications and generation of randomization schedules. • Mentor of biostatisticians within project activities; assigned tasks related to the development of staff within the department. • Present and share knowledge at team meetings and/or at monthly seminars. • Attend bid defense meetings for medium complexity studies in order to win new business. • Represent the department during project-driven client audits. • All other duties as needed or assigned.

Role Description We are seeking an experienced Senior Regulatory Medical Writer to lead authoring and development of high complexity clinical regulatory documents that are critical to the strategic projects of our partner. Imbedded in the team of one of the world´s leading pharma companies, you will be one of the primary Regulatory Medical Writers, project leading the development cycle for high-complexity Phase II-IV clinical regulatory documents. You will own the end‑to‑end medical writing process, from initial planning and cross‑functional coordination through drafting, review, and final delivery, ensuring alignment with project strategy, stakeholder expectations, and agreed timelines. Your contribution will be essential authoring most study-level documents, for example: - Protocols and protocol outlines - Subject Information / ICF - Lay summaries of clinical trial results - IBs - Regulatory briefing packages, responses With minimal supervision, you will: - Lead Kick-off strategy meetings, to align geographically distributed teams, setting goals, milestones, and critical path forward. - Conduct communication strategy meetings and facilitate comment resolution meetings, to consolidate contributions from experts and to manage conflicting comments early, ensuring smooth document development. - Maintain alignment with sponsor goals, project status and milestones across all teams. - Foster regular communication with functional leads/reviewers to streamline document development (getting inputs timely, consolidating contributions, answering questions). - Critically interpret raw study data (efficacy, exposure, end-point, safety, etc.) into clear concise language in Protocols and CSRs. Qualifications - Advanced degree in life-sciences, PhD or Masters - Minimum 4 years of regulatory medical writing experience, including at least 2 years as medical writing project lead. Requirements - Independent authoring, proactively collaborating with stakeholders to author content, drive discussions, and manage the authoring/review process. Personal/Team Skills You´ll be the nexus where multiple teams´ expertise converge. You will leverage your experience to manage writing projects, coordinate and collaborate with stakeholders, steer discussion, drive consensus and facilitate decision-making to propel the document development cycle forward. To drive development of documents of this scale forward, this role requires: - Visibility - Proactivity - Collaboration/teamwork - Excellent communication skills You must be comfortable leading team discussions, managing complex medical writing tasks and processes, engaging with a variety of stakeholders, and confidently contributing your expertise based on experience. Integration within the client´s team is crucial, requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas. Benefits At Fortrea, we empower you to shape your own career path. Whether you are passionate about the medical writing scientific side, or aspire to leadership roles, we provide: - Comprehensive training - Management support - A network of SME’s and KOL’s - Opportunities to help you thrive Your aspirations drive your journey with us. Where do you see yourself?