Fortrea

Clinical Operations

• Responsible for process and performance management related to the delivery of the operational function(s), as assigned.
• Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials.
• Single point of contact for clinical trial teams for all activities associated with risk-based quality management (RBQM).
• Perform a TA-level review of quality plans and risk mitigation approaches to identify any emerging signals or trends.
• Responsible for ensuring comprehensive oversight of all activities delegated to third parties.
• Facilitating and monitoring CTT oversight of vendors.
• Developing, reviewing and revising quality agreements with business partners.
• Ensuring essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organisations.
• Facilitating and overseeing responses to audit and inspection observations as appropriate.
• Analyzing data across therapy areas in order to identify signals and trends and then developing and implementing appropriate process improvement strategies.
• Maintaining current regulatory inspection knowledge regarding GCP inspections by regulatory agencies worldwide.
• Contributing to the development and/or revision of Sponsor policies, SOPs and training materials.
• Developing the strategy for management/support for GCP inspections of Sponsor products.

Clinical Quality Operations Manager

Director

• Work closely with the Product Management team to provide feedback from the field, help shape go-to-market strategies, develop roadmap strategies and ensure deep understanding of market trends, customer needs, and the competitive landscape
• Drive new business opportunities and revenue growth for our clinical trial FSO, FSP and SaaS solutions
• Partner with key internal stakeholders during proposal development, early customer engagement and bid defense meetings to develop project winning innovative strategies.
• Identify, engage, and build strong relationships with key decision-makers at pharmaceutical companies, CROs, and biotech firms
• Be able to clearly identify the FIT product ROI, value proposition and differentiating factors
• Continuously monitor industry trends and competitive offerings to inform sales strategy and positioning.
• Maintain sponsor relationships by providing consulting around Fortrea Intelligent Technology products.
• Lead product demonstrations in partnership with Solution Consultants and Clinical SMEs.
• Have in-depth knowledge of the FIT Products and Product Roadmaps and be able to speak in detail to customers
• Partner with the Clinical Technology Leadership Team to create clear differentiation and ensure rapid market uptake of Fortrea solutions.
• Work with internal stakeholders to develop go-to-market and client engagement strategies to accelerate market adoption of Fortrea Intelligent Technologies
• Collaborate with Marketing to ensure Fortrea Intelligent Technology has a clear market presence including writing papers, attending and speaking at conferences and symposiums.
• Attend and speak at both internal and external events, representing Clinical Technology and Fortrea respectively.
• Promote awareness of FIT internally; educate and support cross-functionally across the Fortrea business on FIT products.
• As required, provide leadership and development of direct reports and junior team members including hiring, performance management, coaching, mentoring etc..
• Assure 100% compliance with SOPs, timesheets and other mandatory company training.

Director, Clinical Technology and Innovation

Software Engineer

• Assume the role of a Lead Statistical Programmer for CP studies only with support from senior programming staff.
• Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client.
• Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs.
• Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs and Reviews Guides to support SDTMs and ADaMs.
• Develop specifications for SDTMs and ADaM datasets with support from senior programming staff.
• Review SAPs and TFL shells from a programming perspective for studies with support from senior programming staff.
• Respond to QA and client audits with support from senior programming staff.

Statistical Programmer II – Sponsor Dedicated

General Counsel

• Collaborate with peer counsels to implement, and continuously improve the global compliance and privacy framework, including policies, standards, governance routines, and controls.
• Act as a subject matter expert in assigned domains including anti-bribery and corruption, Investigations and enforcement, third-party risk management, AI governance and emerging regulation, data privacy and protection (inc. PIPL) and provide escalation support on complex or high‑risk matters.
• Provide practical, risk-based legal advice to global stakeholders and translate regulatory requirements into implementable business processes and controls.
• Lead and/or support risk assessments and documentation, including compliance risk assessments, DPIAs, Transfer Impact Assessments (TIAs), and other reviews for new technologies, digital tools, and AI systems; document mitigations and track implementation.
• Support and/or lead internal investigations and incident response, including ethical concerns, conflicts of interest, fraud/corruption allegations, privacy incidents, and regulatory breaches; ensure consistent standards, escalation, documentation, remediation planning, and reporting obligations where required.
• Draft, review, and maintain global compliance and privacy policies, standards, templates, and guidance for approval by VP Corporate Compliance; ensure alignment with applicable laws and internal governance frameworks and maintain regulator-ready documentation.
• Oversee and optimise privacy operational processes, including data subject rights/DSAR governance, transparency documentation, and privacy notices; partner with operational teams to enable timely and compliant responses within your assign jurisdictional area.
• Advise on compliant cross-border data transfers and related mechanisms and monitor legal developments in your allocated domains affecting international data flows.
• Support third-party risk management by advising on due diligence frameworks, contractual requirements, and monitoring processes for high-risk vendors and engagements, including data processing and AI-enabled services.
• Contribute to risk monitoring, control testing, audit readiness, and regulatory inspection support; coordinate with Internal Audit, Quality, and other functions on reviews and remediation as necessary.
• Contribute to the continuous improvement of compliance systems, processes, and governance structures Support policy development, risk assessments, and guidance within assigned domains Co-develop and deliver training and awareness initiatives and promote a culture of integrity, compliance, and privacy-by-design across the organization as required.
• Support cross-border legal analysis and ensure alignment with local regulatory requirements Partner with key stakeholders including HR, IT, Operations and Quality functions to manage compliance risks.
• Work collaboratively with other counsels within the Compliance & Privacy legal team to enable consistent investigative standards, appropriate escalation and documentation and contribute to remediation planning and regulatory reporting where required.
• Co-develop global training and communication strategies with the compliance team and deliver targeted training in SME areas Promote a culture of integrity and ethical conduct across the organisationShare regulatory updates, enforcement trends, and best practices across the global legal team to ensure consistent interpretation and application of standards worldwide.
• Perform all other duties as needed or assigned.
• Whilst no travel is anticipated for this role, you may be asked to travel up to 10% of your role over the performance period.

Senior Corporate Counsel

Medical Director

• Provide medical safety expertise, directly and indirectly, to Sponsors undertaking clinical trials of drugs, devices, and combination products, and in the post marketing period.
• Responsible for medical review of serious adverse events and adverse events of special interest from Clinical Trials in support of safety activities for clients.
• Develops new and enhances existing client relationships whenever possible.
• Provides medical/safety expertise to colleagues within PSS, including communicating information regarding safety regulations and any changes that have occurred.
• When applicable, responsible for preparation and medical review of Aggregate Reports (such as Periodic Adverse Drug Experience Reports – PADERs) required by global regulatory agencies for review of safety information for assigned products.
• Provides safety support/expertise to project physicians, as appropriate.
• Presents Safety capabilities to clients as part of a proposal team, when appropriate.
• When applicable, responsible for medical review of serious adverse events and non-serious adverse events from spontaneous reports and reports derived from regulatory authorities and the medical literature during post marketing surveillance in support of safety activities.
• When applicable, responsible for signal detection and evaluation activities and preparation and submission of Ad Hoc Reports reviewing specific safety issues to the global regulatory agencies for assigned products.
• All other duties as needed or assigned.

Associate Medical Director – Safety Physician

Manager

• Design and execute change strategies that accelerate adoption, reduce resistance, and deliver measurable business value across major transformation initiatives.
• Lead end-to-end change management strategies for global initiatives.
• Define and communicate the change vision, impact, and value.
• Coach leaders to drive visible sponsorship and engagement.
• Deliver stakeholder, impact, and risk assessments to inform planning.
• Develop and execute targeted communication and training plans.
• Track adoption metrics and drive continuous improvement.
• Partner with HR, IT, and L&D to ensure successful implementation.
• Build and manage SharePoint-based communication hubs and content.

Senior Change Management Manager

Clinical Research

• Lead statistical strategy and delivery for complex studies and programs (including submissions and multi-protocol work)
• Develop and review Statistical Analysis Plans and ensure quality of statistical outputs
• Provide oversight of statistical analyses, Tables, Figures & Listings (TFLs), and study reporting
• Collaborate closely with cross-functional teams and act as a key statistical advisor
• Support regulatory interactions, publications, and post hoc analyses
• Contribute to study design, protocols, and randomization planning
• Mentor junior statisticians and provide technical leadership
• Represent Biostatistics in client interactions, bid defenses, and audits

Principal Biostatistician

• Define and execute the clinical platforms product strategy and roadmap, aligned to Fortrea’s enterprise and clinical delivery objectives.
• Lead end-to-end product development lifecycle, including ideation, engineering, validation, deployment, and lifecycle management of applications.
• Drive adoption of a product-centric operating model (agile, DevOps, customer-first delivery).
• Ensure solutions are scalable, secure, and compliant with regulatory requirements within clinical research.
• Evaluate and integrate digital health, AI/ML, and emerging technologies to enhance clinical trial and delivery and patient experience.
• Continuously evaluate market trends, competitive landscape, and technology trends to ensure Fortrea maintains competitive position in the marker.
• Lead the day-to-day operating model for Clinical Platforms, ensuring delivery predictability, quality, and efficiency.
• Own PMO governance, portfolio prioritization, and execution discipline across platform initiatives.
• Establish consistent delivery standards, reporting cadence, and performance metrics.
• Proactively identify and mitigate risks, dependencies, and resource constraints.
• Ensure alignment between product roadmaps and delivery capacity.
• Drive continuous improvement in delivery speed, cost efficiency, and quality outcomes.
• Ensure platforms support the end-to-end clinical trial lifecycle, including study startup, site management, data capture, monitoring, safety, and regulatory submission.
• Translate clinical and operational needs into technology-enabled solutions that improve efficiency, compliance, and data integrity.
• Act as the primary integrator across Clinical Operations, Commercial, Quality, Regulatory, Security, and Data Privacy.
• Partner with business leaders to ensure clear accountability, governance, and decision-making across complex initiatives.
• Ensure platform capabilities are effectively adopted and embedded within the business.
• Simplify complexity through clear ownership and streamlined processes.
• Develop and deliver platform narratives, demonstrations, and supporting materials.
• Partner with Commercial and Business Development teams to position platforms as a differentiated capability.
• Own development of executive-level communications, presentations, and external-facing materials.

Executive Director, Clinical Platforms, Product Development

Project Manager

• Evaluate the impact of clinical/regulatory changes on assigned projects as well as Fortrea business operations
• Manage the preparation of high-quality submissions (or parts of submissions) to regulatory authorities pre and post marketing approval within project timelines
• Monitor project schedule and scope to ensure both remain on track
• Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Fortrea and client requirements
• Propose and implement improvements to enhance efficiency and quality of the work performed on assigned projects

Regulatory Affairs Project Manager

Operations

• Manage end-to-end movement of safety cases through all case processing workflow steps, responsible for ensuring timely case progression, identifying and mitigating workflow delays, and coordinating staffing coverage to support compliance with all reporting timelines.
• Monitor workload distribution across teams and ensure optimal resource utilization.
• Track case processing timelines to ensure compliance with regulatory and partner reporting requirements.
• Identify workflow bottlenecks and implement corrective actions.
• Provide workflow updates and performance metrics to leadership.
• Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided.
• Perform vendor and partner reconciliation activities as required.
• Participate in project team and client meetings, where appropriate and prepare for and / or participate in client or regulatory audits.
• Lead initiatives to enhance efficiency, reduce turnaround times, and improve data quality.
• Monitor KPIs (e.g., case cycle time, compliance rates, backlog trends).
• Collaborate with QA teams to maintain high-quality case processing and documentation standards.
• Support audit and inspection readiness activities.
• Maintain a comprehensive understanding of applicable Standard Operating Procedures (SOP), Work Instructions (WI), guidance documents, directives associated with Safety management, reporting and pharmacovigilance.
• Ensure all PV activities comply with global regulatory requirements (FDA, EMA, ICH E2E guidelines, etc.).
• All other duties as needed or assigned.

Workflow Manager – Pharmacovigilance Operations

Security Engineer

• Design, configure, and maintain scalable Workday security architecture, including role-based, user-based, and intersection security groups.
• Define and enforce governance standards for Workday security configuration and ongoing maintenance.
• Continuously evaluate and optimize security models to align with organizational and regulatory requirements.
• Manage and administer domain security policies, business process security policies, and proxy access.
• Implement and maintain segmented and least-privilege access models across Workday modules.
• Ensure role assignments are aligned with job responsibilities and organizational hierarchy.
• Partner with GRC, Legal, and Audit teams to ensure adherence to regulatory frameworks (e.g., SOX, GDPR).
• Lead and execute User Access Reviews (UARs), ensuring timely remediation of identified issues.
• Support internal and external audits by providing documentation, audit evidence, and remediation plans.
• Implement and maintain Segregation of Duties (SoD) controls and monitoring processes.
• Configure and review security for inbound and outbound Workday integrations.
• Ensure secure authentication and authorization mechanisms for integrations (e.g., API users, ISUs, certificates).
• Investigate, troubleshoot, and resolve Workday security-related incidents and access issues.
• Collaborate with HR, Payroll, Finance, and IT teams to gather security and reporting requirements.
• Build and support Workday security reports and dashboards.
• Provide guidance on least-privilege access design and security best practices.

Senior Manager, Workday Security

• The Workday Reporting & Integrations Lead is responsible for driving the design, development, and governance of Workday integrations and reporting solutions.
• Lead the design, development, testing, and deployment of inbound and outbound integrations across Workday HCM, Financials, and third-party systems.
• Troubleshoot integration failures, resolve data transmission issues, and coordinate with external vendors to ensure seamless data exchange.
• Lead stakeholder discussions and report rationalization sessions to understand and optimize reporting requirements.
• Design, build, and maintain complex Workday reports, including Advanced, Matrix, Composite, and BIRT reports.

Senior Manager – Workday Integrations and Reporting

Research Analyst

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites
• Conduct pre-study and initiation visits
• Ensure informed consent procedures and protocol requirements are adhered to
• Monitor data for missing or implausible data
• Complete Serious Adverse Event (SAE) reporting
• Assist with training of new employees

Clinical Research Associate II, Phase I

• The Manager, Start-up Operations is accountable for delivering on-time, high quality study start-up and maintenance activities within a country, or country cluster.
• Lead a startup team within a country or a cluster of countries that will work to activate study sites.
• Ensure filing of documentation into the eTMF system and completion of CTMS from the start to the end of the start-up period.
• Direct line management responsibility for the start-up operations team.
• Act as a local point of contact for activities around start-up deliverables in the country.
• Ensure right commitments and right timelines are met.
• Serve as the local Subject Matter Experts (SME) for start-up processes including timelines, training, and development of the start-up team at the local level.

Manager, Site Readiness – FSO

Content Writer

• Develop and/or review initial/amended Core Informed Consent Forms (ICFs)
• Review Core/Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines
• Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks
• Support system compliance and system data entry, as applicable
• File required task-related documentation in the Electronic Trial Master File (eTMF)
• Liaising and follow-up with local teams, Start-up Project Managers, and Sponsors to assure timely approval of Informed Consent Forms in order to meet submission deadlines
• Act as Document Review mentor for lower-level staff and help train lower-level staff on Document Review processes and expectations
• Oversee Local Investigator Package reviewers work for a specific country
• Serve on SOP Review Team(s) as expert in Document Review processes and expectations
• Serve as a Subject Matter Expert for partnership processes on Document Review activities such as Informed Consent Form
• And all other duties as needed or assigned