Freelance Study Start Up Specialist (0.8 FTE)

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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 is part of Site Management and Start Up Unit, within TFS Develop and will function operationally as a member of a Project Team being responsible of startup activities according to company policies, SOPs and regulatory requirements in addition to financial and contractual obligations.

Key Responsibilities

• Perform the startup activities of assigned studies within a country or region ensuring that those are performed on‑time, within the scope and in compliance with ICH/GCP guidelines, SOPs and protocol requirements.
• Collect, review, approve processes and track regulatory & investigator documents required for study site activation.
• Prepare and complete regulatory process (IEC/IRBs) including asking for requirements to the EC/IRBSs, preparing and collecting 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 are granted, IP Release authorized and specific project deliverables are completed.
• Participate in site evaluation and feasibility process for assigned projects.
• Review and provide feedback to management on site performance related to startup activities.

Qualifications

• Bachelor’s Degree preferred.
• Good knowledge of GCP/ICH guidelines.
• Good knowledge of applicable regulatory requirements, SOPs and company’s 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 and Polish.
• 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, coupled with a good understanding of working in a team environment.
• 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.

About Us

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. Bringing together over 800 professionals, we deliver 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 all decisions and foster a culture of innovation and excellence.