TFS HealthScience

Lead and manage TMF and CRA teams, oversee operational and compliance activities, and contribute to strategic planning within the clinical research domain. | Minimum 9 years in pharmaceutical or CRO industry with leadership experience in TMF and CRA teams, strong knowledge of clinical regulations, and therapeutic area experience. | TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. Join Our Team as a Director Project Delivery - home based in Poland, Portugal, Italy, Sweden or UK. About this role We are seeking an experienced and dedicated Line Manager to lead our Trial Master File (TMF) and Clinical Research Associate (CRA) functional teams within the dynamic Ophthalmology Business Unit. This critical role involves strategic oversight, team leadership and operational management to ensure the efficient execution of clinical trials and the maintenance of regulatory compliance. Key Responsibilities: Team Leadership & Line Management: • Provide strong leadership, mentorship, and line management to a team of TMF Specialists and Clinical Research Associates, fostering a culture of accountability, excellence, and continuous improvement. • Manage day-to-day resourcing activities, including workload balancing, task delegation, and resource allocation across various clinical studies to ensure project milestones are met efficiently. • Oversee performance management processes, including goal setting, regular feedback, career development planning, and conducting annual performance reviews. Oversight of KPIs: • Establish, monitor, and report on corporate and role-based Key Performance Indicators (KPIs) for both the TMF and CRA teams. • Utilize KPI data to identify trends, drive process improvements, and ensure functional teams are meeting performance targets and quality standards. TMF Strategy & Budgeting: • Hold responsibility for supporting TMF-related activities during the pre-award budget planning phase, including resource estimation and proposal input. • Contribute to the operational strategy for TMF management, ensuring inspection readiness, data integrity, and compliance with all applicable regulations (GCP, ICH guidelines, etc.). • Drive the implementation and adoption of TMF systems and best practices within the Ophthalmology unit. Operational Excellence & Compliance: • Ensure all clinical operations activities, particularly those related to the TMF and site monitoring, adhere strictly to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. • Act as a subject matter expert during internal/external audits and regulatory inspections pertaining to TMF documentation. • Collaborate cross-functionally with OPH Project team, BD, TFS Subject Matter Experts, and OPH Leadership teams to streamline processes and achieve operational synergies. Qualifications: • A Bachelor of Science (BSc) or master’s degree in life science • Minimum 9 years relevant experience in pharmaceutical or CRO industry with increasing levels of responsibility, including line management of Trial Master File and Clinical Research Associate Teams • Strong knowledge of regulations, standards and guidelines such as ICH E6, 21 CFR Part 11 • Strong leadership skills. • Relevant therapeutic area experience • Experience in project management, people management, problem-solving and team leadership • Ability to deal effectively with sponsors and internal customers at all levels • Willingness and ability to travel on occasion • Excellent verbal and written communication skills What We Offer We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients A Bit More About Us Our journey began over 29 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 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.

Manage site relationships and oversight for clinical trials, ensuring protocol compliance and supporting enrollment through frequent travel. | Bachelor's degree in life sciences or related field, clinical research experience, strong communication, organizational skills, and knowledge of GCP and regulatory requirements. | TFS HealthScience is a leading mid-sized Contract Research Organization (CRO) dedicated to partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. Our Clinical Operations team, led by industry experts, combines the full-service capabilities and global reach of a large CRO with the flexibility and personal approach of a mid-sized CRO. As a member of our SRS team, you will be fully dedicated to a single sponsor based in the United States. This is a contract-based position. Responsibilities: Relationship Building: Develop and maintain strong relationships with key personnel at clinical trial sites, including principal investigators, site coordinators, and other site staff. Liaison Role: Serve as a bridge between the sponsor and clinical trial sites, ensuring clear and timely communication of study protocols, updates, and key information. Site Oversight: Conduct Monitoring Oversight Visits and regular site engagement activities to ensure high-quality trial execution. Enrollment Support: Design customized site-level engagement plans to help drive enrollment and support timely patient recruitment. Issue Resolution: Collaborate with CRO CRAs and Medical Science Liaisons to identify, mitigate and resolve site-level challenges. Feasibility Support: Participate in feasibility and site qualification visits, collaborating with CRO representatives. Advocacy Engagement: Represent the sponsor at local and regional patient advocacy or support group meetings when needed. Reporting: Track and report site engagement activities, enrollment status, and performance metrics. Travel Requirements: This is a very high travel position with at least 75% travel. Sites will primarily be located in the Central USA region, though travel outside this area may occasionally be required. Requirements: Bachelor's degree in a relevant field (life sciences, nursing, healthcare management). Proven experience in clinical research and site relationship management. Excellent communication and interpersonal skills. Proactive problem-solving abilities. Strong organizational and project management skills. Solid understanding of GCP and regulatory requirements. Contract Type: 1.0 FTE Therapeutic Areas: Rheumatology

Develop and execute business development strategies, drive new client acquisition, manage client relationships, and support proposal development in the CRO industry. | Minimum 5 years in clinical research or CRO sales, proven consultative sales experience, strong negotiation skills, and ability to work independently. | TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. Join Our Team as a Director Business Development - home based in the Boston area, United States (New England States - Massachusetts, Maine, New Hampshire, Vermont, Rhode Island, Connecticut). About this role We are seeking an experienced and results-driven Director Business Development to join our North American Clinical Development Services (CDS) team. In this role, you will collaborate with a highly skilled and motivated group of professionals, driving new partnerships and expanding our presence in the U.S. market. As Director Business Development, you will be responsible for strategic sales planning, client relationship management and overall growth of CDS. You will work cross-functionally with internal teams to ensure seamless support for new and existing clients. Key Responsibilities Develop and execute a business development strategy focused on the North American biotech/pharma market Drive new business acquisition to meet or exceed annual sales targets Identify and qualify new leads, managing the full sales lifecycle from initial outreach to contract negotiation Collaborate with internal teams to respond to Requests for Information (RFIs) and Requests for Proposals (RFPs) Prepare TFS teams for client engagements, including Capabilities Presentations and Bid Defense Meetings (BDMs) Manage contract and budget discussions post-award to ensure alignment and client satisfaction Establish and maintain strong relationships with prospective and current clients Organize and deliver high-quality sponsor presentations that communicate the value of TFS’ CDS services Provide strategic input and leadership during proposal development Monitor project status post-award and coordinate scope changes as needed Track competitive intelligence and market trends in the CRO space Represent TFS at industry conferences and tradeshows in North America Manage travel and expense reporting in compliance with company guidelines Qualifications Bachelor’s Degree or equivalent relevant experience Minimum of 5 years of experience in clinical research, business development, or sales within the CRO industry Proven track record of at least 3 years in consultative sales with strong negotiation and closing skills Strong communication skills with the ability to engage and influence clients and stakeholders at all levels Deep understanding of clinical development and the regulatory landscape in the U.S. Strong organizational skills, self-starter, and comfortable working independently in a remote environment Experience with CRM tools and Microsoft Office Suite Excellent presentation and proposal development skills Willingness to travel across North America to attend client meetings, conferences and internal events as needed What We Offer We provide a competitive salary and performance-based incentives, comprehensive benefits and the opportunity for personal and professional growth in a rewarding, global environment. Remote work flexibility and a collaborative, mission-driven environment focused on patient outcomes and clinical innovation. You’ll be joining a team that values collaboration, innovation and making a difference in the lives of patients A Bit More About Us Our journey began over 29 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 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.

Oversee hospital-based clinical trial sites and CROs, ensure compliance and quality, conduct site visits and remote reviews, identify risks, and develop corrective action plans. | Senior clinical research management experience with clinical trial monitoring, quality assurance expertise, oncology or infectious disease exposure, and strong communication skills. | We are seeking an experienced Project Manager / Senior Clinical Research Manager (PM/SCRM) to provide oversight and quality assurance support for an ongoing hospital-based study in the US. This senior role requires a strong background in clinical operations, with responsibilities focused on reviewing site and CRO performance, identifying risks, and preparing corrective action plans to ensure study delivery. Key Responsibilities • Oversee performance of approx. 20 hospital-based sites across the US. • Provide quality oversight of CRO activities, ensuring compliance with protocol, ICH/GCP, and regulatory requirements. • Conduct a combination of onsite visits and remote reviews to evaluate study progress. • Identify operational issues and develop corrective and preventive action plans (CAPA). • Serve as a liaison between sponsor, CRO, and site teams. • Contribute to study governance and oversight reporting. Requirements • Strong background as a CRA/CTM, with extensive clinical trial monitoring and management experience. • Experience in hospital-based studies; prior exposure to oncology and infectious diseases is highly desirable. • Demonstrated expertise in quality assurance and oversight of clinical operations. • Excellent communication and organizational skills, with ability to work independently across multiple stakeholders. Assignment Details • FTE level: 0.5–1.0 depending on availability. • Contract length: 6 months. • Start date: As soon as practical. • Travel: Site visits required (frequency and scope to be agreed; remote oversight possible for some activities). What We Offer • Competitive compensation and benefits. • Opportunity to work on impactful studies in a collaborative international environment. About TFS Our journey began more than 25 years ago in Lund, Sweden. Today, TFS operates in 17 countries across Europe, North America, Asia-Pacific, and the Middle East, delivering tailored clinical development solutions to our partners. Our core values — Trust, Quality, Flexibility, and Passion — define who we are and guide how we work. They are the foundation of our culture and our success.