Freelance Study Start Up Specialist (1.0 FTE)

TFS HealthScience; Remote; GBP 60,000 - 80,000; Full time

Job summary

A global Contract Research Organization is seeking a Freelance Study Start Up Specialist based in the UK. This role involves managing startup activities, ensuring compliance with ICH/GCP guidelines, and handling investigator contracts. Ideal candidates will have a Bachelor's degree and 1-3 years of clinical experience, with strong communication and organizational skills. Enjoy a competitive compensation package and an opportunity for professional growth in a collaborative environment.

Benefits

Competitive compensation package

Comprehensive benefits

Opportunities for personal and professional growth

Qualifications

• Minimum 1‑3 years of relevant clinical experience.
• Previous experience with investigator start‑up documents and investigative sites is preferred.
• Experience working with cross‑functional teams.

Responsibilities

• Perform the startup activities of assigned studies on time.
• Collect, review, approve, and track regulatory documents.
• Collaborate with Regulatory department on submissions.
• Ensure contracts and approvals are granted.
• Review site performance related to start‑up activities.

Skills

Good written and communication skills in English

Good knowledge of GCP/ICH guidelines

Good organizational skills

Strong software and computer skills

Ability to work under pressure

Education

Bachelor's Degree preferred

Job description

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 Freelance Study Start Up Specialist (SSU Sp) – home based in the UK

About this role: As part of our Study Start Up team you will work alongside passionate and innovative professionals to ensure our customers achieve their goals. The Study Start Up Specialist (SSU Sp) is part of the Site Management and Start Up Unit within TFS Develop and will function operationally as a member of a Project Team responsible for startup activities according to company policies, SOPs and regulatory requirements, in addition to financial and contractual obligations. The SSU Sp must contribute to ensuring the planned start‑up plan is executed, maximizing the recruitment window of assigned studies. Activities include feasibility and site identification, study site initiation, interaction with Ethics Committees and handling investigator contracts.

Key Responsibilities

• Perform the startup activities of assigned studies within a country or region ensuring that those are performed on‑time within scope and in compliance with ICH/GCP guidelines, SOPs and protocol requirements.
• Collect, review, approve process and track regulatory & investigator documents required for study site activation.
• Prepare and complete regulatory process (IEC/IRBs) including requests for requirements to the EC/IRBs, preparation and collection of specific documentation, submission and amendments, regulatory fees.
• Collaborate with Regulatory department regarding HA/CA submission/notification.
• Main responsible for ensuring the quality control of documentation included in any submission/notification.
• Adapt Informed Consent documents according to local law and document the process following guidelines and SOPs.
• Ensure contracts are fully executed, regulatory documents and approvals granted, IP Release authorized and specific project deliverables completed.
• Participate in site evaluation and feasibility process for assigned projects.
• Review and provide feedback to management on site performance related to start‑up activities.

Qualifications

• Bachelor's Degree preferred.
• Good knowledge of GCP/ICH guidelines.
• Good knowledge of applicable regulatory requirements, SOPs and company Corporate Standards.
• Minimum 1‑3 years of relevant clinical experience.
• Previous experience with investigator start‑up documents and investigative sites is preferred.
• Good written and communication skills in English.
• Good organizational skills and experience working with cross‑functional teams.
• Strong software and computer skills.
• Capable of multi‑tasking and working well under pressure to meet deadlines and a good understanding of team working.
• Travel within this position is limited.

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 guide us in decision‑making at all levels. These values help attract and retain talent, boosting engagement and satisfaction and fostering a culture of mutual respect and collaboration.

Together we make a difference.

Key Skills

• English
• Cathodic
• Communication
• Journalism
• Arbitration Law

Employment Type

Full Time

Experience Required

Years

Vacancy

1

Location

Freelance Specialist • London, England, UK