Remote Study Start-Up Specialist – Poland

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 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.