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.