Study Start Up Specialist

TFS HealthScience; Warszawa; Remote; PLN 100,000 - 140,000; Full time

Job summary

TFS HealthScience is seeking a Study Start Up Specialist to support clinical trials from a home-based role in Poland. You will coordinate site activation, regulatory submissions, ethics committee communications, and TMF maintenance, collaborating with project teams, sites, investigators, and regulators to ensure timely study activation.

The position requires a life sciences degree and 1–2 years SSU experience, solid ICH-GCP knowledge, CTIS submissions experience, and site contract negotiations.

Qualifications

• 1–2 years SSU experience
• Solid understanding of ICH-GCP guidelines and regulatory requirements
• Experience handling site start-up documentation and regulatory submissions
• Experience with CTIS submissions and site contracts negotiations

Responsibilities

• Manage study start-up activities for assigned projects per timelines and ICH-GCP standards.
• Collect, review, process, and track regulatory and investigator documentation for site activation.
• Prepare and coordinate submissions/amendments to Ethics Committees/IRBs and regulatory notifications.
• Ensure quality/completeness of all documentation in submissions.
• Adapt informed consent forms per local regulations and procedures.
• Coordinate investigator contracts and support contract negotiations with internal stakeholders.
• Participate in site identification, feasibility assessments, and site evaluation activities.
• Maintain accurate start-up information in systems and TMF.
• Support study set-up, site activations, status reporting, and project tracking.
• Contribute to process improvements and audit/inspection readiness.

Skills

SSU experience

Regulatory submissions

ICH-GCP knowledge

Ethics Committee submissions

Contract negotiations

CTIS submissions

Site activation coordination

Documentation management

Education

Bachelor's degree in Life Sciences

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 Study Start Up Specialist, home-based in Poland.

About this role

As part of our CDS Dermatology team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals.

As a Study Start Up Specialist, you will support the delivery of clinical trials by ensuring all study start-up activities are completed efficiently, compliantly, and within agreed timelines. Working closely with project teams, sites, investigators, regulatory authorities, and ethics committees, you will help maximize recruitment opportunities and support successful study activation.

Key Responsibilities

• Manage study start-up activities for assigned projects in accordance with timelines, protocol requirements, SOPs, and ICH-GCP guidelines.


• Collect, review, process, and track regulatory and investigator documentation required for site activation.


• Prepare and coordinate submissions and amendments to Ethics Committees/IRBs and support regulatory authority notifications.


• Ensure the quality and completeness of all documentation included in submissions.


• Adapt informed consent forms according to local regulations and company procedures.


• Coordinate investigator contracts and support contract negotiations with internal stakeholders.


• Participate in site identification, feasibility assessments, and site evaluation activities.


• Maintain accurate and up-to-date start-up information within company systems and repositories.


• Support Trial Master File (TMF) maintenance and ensure documentation is filed appropriately and on time.


• Assist project teams with study set-up, site activations, status reporting, and project tracking.


• Contribute to process improvement initiatives across Clinical Operations.


• Support audit and inspection readiness activities.


• Participate in project-specific responsibilities, including investigator payments, invoice tracking, financial reconciliation, and clinical study report support, when required.

Qualifications

• Bachelor's degree in Life Sciences or a related field preferred.


• Minimum 1-2 years of SSU experience.


• Solid understanding of ICH-GCP guidelines and applicable regulatory requirements.


• Experience handling site start-up documentation and regulatory submissions.


• Experience with CTIS submissions


• Experience with site contracts negotiation


• Nice to have: experience with MDR submissions.

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 30 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 600 professionals, TFS delivers tailored clinical research services in more than 50 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 foster a culture of mutual respect and collaboration.

Securing the Path from Science to Life