Role Description NIVA Health is seeking an experienced and results-oriented Director of Operations to lead and scale operational performance across our growing mobile healthcare organization. This fully remote leadership position is responsible for overseeing regional clinical operations through a team of Directors of Nursing (DONs) who manage mobile wound care providers delivering services in skilled nursing facilities, assisted living communities, patients' homes, and other post-acute care settings. The Director of Operations will serve as a key operational leader responsible for driving performance, accountability, quality outcomes, patient satisfaction, provider productivity, workforce development, and operational excellence across multiple markets. - Provide strategic and operational oversight for multiple markets and clinical service regions. - Lead a team of Directors of Nursing responsible for supervising mobile wound care provider teams. - Ensure consistent execution of operational standards, workflows, and performance expectations across all regions. - Develop scalable systems, processes, and infrastructure to support organizational growth. - Monitor operational performance and implement improvement initiatives to increase efficiency and effectiveness. Qualifications - Bachelor's degree in Healthcare Administration, Nursing, Business Administration, Public Health, or related field. - Minimum 5 years of healthcare operations leadership experience. - Experience managing leaders who oversee clinical or healthcare service teams. - Demonstrated success leading multi-site or geographically dispersed healthcare operations. - Strong experience with staffing, workforce management, operational metrics, and performance improvement. - Exceptional leadership, communication, and organizational skills. - Preferred: Licensed Nursing Home Administrator (LNHA/NHA) experience. - Preferred: Regional Director of Operations experience. - Preferred: Home Health, Post-Acute Care, Skilled Nursing, Assisted Living, Hospice, Mobile Healthcare, or Value-Based Care experience. - Preferred: Master's degree (MBA, MHA, MPH, MSN, or related field). - Preferred: Experience scaling healthcare operations across multiple states or markets. Requirements - Manage operational budgets and resource allocation. - Monitor productivity, labor utilization, and operational efficiency metrics. - Identify opportunities to improve profitability while maintaining exceptional patient care. - Support forecasting, strategic planning, and market expansion initiatives. - Lead operational implementation of new markets, service lines, and organizational initiatives. - Partner with executive leadership on strategic growth planning. - Support integration of technology, automation, and workflow optimization initiatives. - Drive successful organizational change management efforts. Benefits - Full-time position (8am-5pm EST). - Remote work (U.S.). - 15–30% travel for leadership meetings, market visits, training, and operational oversight. Key Performance Indicators - Patient satisfaction and experience scores. - Clinical team retention and engagement. - Provider productivity and utilization. - Operational efficiency metrics. - Quality and compliance performance. - Market growth and expansion goals. - Revenue and profitability targets. - DON leadership development and performance.

Role Description As part of our CDS Therapeutic area / Ophthalmology team, you will work alongside passionate and innovative professionals to ensure our customers achieve their goals. The Trial Master File Lead is responsible for organizing, maintaining, and overseeing the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, PM delegation, and coordinating main tasks under TMF Business Line. This role may act as Line Manager for TMF Associates. - Create the Study TMF EDL in cooperation with PM (Project Manager) and study team. - Create the first draft of TMF Plan, implement changes after review, generate final version, and distribute final version to the study team. - Create TMF at Trial, Country, and Site Level (paper TMF). - Control if the Electronic Trial Master File (eTMF) at Trial, Country, and Site Level was properly created by Clinical Business Administrator (CBA) team when TFS system is used. - Inform the study team that TMF is created and ready for document upload for eTMF or submission to paper TMF (pTMF). - Actively follow up with the study team to ensure documentation is submitted following the process described in The TMF Plan and that the TMF is always audit and inspection ready. - Set up the Investigator’s File as directed by Clinical Research Manager (CRM) and forward the CRM a tracker of all document sections within the ISF. This activity may be delegated to TMF A and/or Project Management Associate (PMA) depending upon study needs. - Actively collaborate in the training of the study team regarding the TMF workflow and management. - Act as contact person for the study team to support TMF doubts or TMF issues and ensure TMF is always inspection ready. - Maintain and follow up TMF status, identify areas with missing documentation and inconsistencies, and follow up with the study team for resolution. - Perform Quality Check of each document before filing in TMF and follow up issues until resolution. - Perform Quality Check of each uploaded document after filing in eTMF and follow up issues until resolution. - Responsible for creating and maintaining paper TMF (pTMF) tracker and generating reports for eTMF. - Generate metrics supporting TMF completeness and accuracy. Qualifications - 5 and above years of proven relevant experience in Clinical Trials with TMF management including oversight and quality control. - Deep knowledge of GCP/ICH guidelines. - Strong understanding of the impact of the TMF on Study management. - Strong written and communication skills and demonstrate ability to communicate and coordinate within the group of TMF stakeholders. - At least 1 year of proven people management. Benefits - Competitive compensation package. - Comprehensive benefits. - Opportunity for personal and professional growth in a rewarding environment. - Joining a team that values collaboration, innovation, and making a difference in the lives of patients. Company Description Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. - Core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decision-making. - High employee engagement and satisfaction through alignment on fundamental values. - Fostering a culture of mutual respect and collaboration.

Role Description Our FSO team is seeking a Cell & Gene Therapy Clinical Project Manager to join our growing team. This role requires 2+ years of global project management experience, with experience in cell & gene therapy. Candidates must be based in the United States. Project Managers own the operational strategy, determining the most cost effective and efficient means to successfully run and complete projects on time, while maintaining quality, remaining within budget, while meeting the customer’s needs and adhering to the contract. A successful Project Manager will bring innovation and future focused approaches to clinical trials with a focus on patient centricity and consistent solutions-oriented delivery. Summary of Responsibilities - Take accountability for proactively driving project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence. - Take ownership of the customer relationship while drawing on the Company’s pool of experts. - Drive communication and collaboration with the client and project team across a matrixed, multi-cultural environment. - Lead the development of the project strategy and ensure prioritization with the project team and key stakeholders. - Prepare and deliver presentations for new business as required. - Lead the identification of project, financial and quality risk leveraging end to end risk management practices and quality by design principles. - Utilize data sources, dashboards, and risk management strategies to drive innovation and proactive problem solving. - Lead the adherence to project governance and issue escalation pathways. - Partner with project team members and key stakeholders to oversee and manage project budgets, resources, and scope. - Ensure adherence to established budget and financial milestones. - Accountable for accurately forecasting project revenue and managing project costs in adherence to the budget. - Leading the timely management of changes to scope and the change order process. - Ensure project team awareness and tracking of KPIs for any client specific metrics. - Provide inspiring leadership and play a key role in the creation of high performing project teams. - Facilitate communication and teamwork while driving delivery. - Ensure that resource projections are accurate and visible to resourcing teams. - Develop and mentor team members in multiple areas of expertise and provide feedback as needed. - All other duties as needed or assigned. Qualifications - University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution. - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Requirements - Minimum of five (5) years of relevant clinical research experience in a pharmaceutical company/CRO. - 2+ years of Clinical Project Management experience within a CRO or pharma company. - Experience working on Cell & Gene Therapy studies. - Experience working with Biotech clients. - In lieu of the above requirement, candidates with (a) six (6) years supervisory experience in a health care setting and (b) five (5) years clinical research experience including one (1) years of project management experience will be considered. - Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs. - Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access, and Power Point). - Experience managing projects in a matrix and virtual environment. - Excellent communication, planning, and organizational skills. - Demonstrated ability to lead by example and to encourage team members to seek solutions independently. - Demonstrated ability to handle multiple competing priorities and to utilize resources effectively. - Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system. - Financial awareness and ability to actively utilize financial tracking systems. - Ability to work independently and mentor junior project team members. - Ability to negotiate and liaise with clients in a professional manner. - Ability to present to staff at all levels. Preferred Qualifications Include - Master’s or other advanced degree. - PMP certification. Benefits - Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: - Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers). - 401(K). - Paid time off (PTO) – Flex Plan. - Employee recognition awards. - Multiple ERG’s (employee resource groups). - Target Pay Range (based on title): $125 - 135k. Physical Demands/Work Environment - Standard Office Environment or remote based work required. - Weekend and off-hour work as required. Travel Requirements - Local, Domestic, Regional, Global. - Identify the expected travel requirements of the position on an annual basis: - % of time: up to 30%. - % of the above that requires overnight stay: up to 30%. - Travel is primarily to where: domestic and international travel.

• Take accountability for proactively driving project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence. • Take ownership of the customer relationship while drawing on the Company’s pool of experts. • Drive communication and collaboration with the client and project team across a matrixed, multi-cultural environment. • Lead the development of the project strategy and ensure prioritization with the project team and key stakeholders in the creation of clear, data driven strategies and proactive management of project scope, timelines, quality, and budget. • In collaboration with relevant departments, prepare and deliver presentations for new business as required. • Lead the identification of project, financial and quality risk leveraging end to end risk management practices and quality by design principles. • Appropriately utilize data sources, dashboards, and risk management strategies to drive innovation and proactive problem solving with the project and client teams. • Lead the adherence to project governance and issue escalation pathways, ensuring that project plans are in place to address identified risk while adhering to professional standards, SOPs, client, and regulatory requirements. • Partner with project team members and key stakeholders to oversee and manage project budgets, resources, and scope. • Ensure adherence to established budget and financial milestones. • Accountable for accurately forecasting project revenue and managing project costs in adherence to the budget. • Leading the timely management of changes to scope and the change order process. • Ensures project team awareness and tracking of KPIs for any client specific metrics. • Provide inspiring leadership and play a key role in the creation of high performing project teams. • Facilitating communication and teamwork while driving delivery, ensuring that team members understand contracted scope, timelines, and budget. • Ensures that resource projections are accurate and visible to resourcing teams, proactively escalating resource constraints and challenges. • Develops and mentors team members in multiple areas of expertise and provides feedback as needed to respective line managers. All other duties as needed or assigned.