Study Start Up Lead

About this role

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.

As we continue to grow our Internal Medicine and Neuroscience Business Unit, we are seeking an experienced Study Start-Up Lead to join our team on a 0.4 FTE basis.

As the Study Start-Up Lead, you will play a critical role in shaping the success of our clinical programs by driving essential start-up activities across the UK and contributing to global initiatives. You will collaborate cross-functionally with internal teams and external partners to ensure regulatory, ethical, and operational readiness, helping our clients advance their therapies efficiently and compliantly.

Please keep in mind that this is a freelance role for only 0.4 FTE.

Key Responsibilities

• Lead and oversee all study start-up activities for assigned projects within the Internal Medicine & Neuroscience BU.
• Serve as the primary point of contact for start-up timelines, deliverables, and strategic planning.
• Coordinate submissions to ethics committees, Regulatory Authorities, and other relevant bodies.
• Support site identification, feasibility, and site activation processes.
• Provide guidance to project teams on regulatory and operational considerations during early study phases.
• Maintain clear, proactive communication with internal stakeholders and clients.
• Ensure compliance with ICH-GCP, local regulations, and TFS SOPs.

Qualifications and Experience

• Proven experience in study start-up within a CRO or pharmaceutical environment.
• Strong knowledge of UK regulatory and ethics submission processes.
• Experience in Internal Medicine and/or Neuroscience studies is highly advantageous.
• Excellent communication, organization, and time-management skills.
• Ability to lead cross-functional coordination and problem-solving.
• Comfortable working in a part-time (0.4 FTE) capacity.

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 27 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.