Study Start Up Specialist

🔥 15 hours ago

🇵🇱 Poland – Remote

⏰ Full Time

🟢 Junior

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Manage study start-up activities for assigned projects according to timelines, protocol requirements, SOPs, and ICH-GCP guidelines • Collect, review, process, and track regulatory and investigator documentation for site activation • Prepare and coordinate submissions and amendments to Ethics Committees/IRBs and regulatory authority notifications • Ensure submission documentation quality and completeness • Adapt informed consent forms to local regulations and company procedures • Coordinate investigator contracts and support contract negotiations • Participate in site identification, feasibility assessments, and site evaluation • Maintain accurate start-up information in company systems and repositories • Support Trial Master File maintenance and timely document filing • Assist with study setup, site activations, status reporting, and project tracking • Contribute to Clinical Operations process improvements • Support audit and inspection readiness • Support investigator payments, invoice tracking, financial reconciliation, and clinical study report activities when required

🎯 Requirements

• Bachelor's degree in Life Sciences or a related field preferred • Minimum 1-2 years of Study Start-Up (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 contract negotiation • Experience with MDR submissions is nice to have • Work home-based in Poland

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative and innovative work environment • Home-based/fully remote work

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