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Study Start Up Specialist
TFS HealthScience - Contract Research Organization. Manage study start-up activities for assigned projects according to timelines, protocol requirements, SOPs, and ICH-GCP guidelines .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing study start-up activities, ensuring compliance with ICH-GCP guidelines, and handling regulatory submissions. Proficient in site contract negotiation and maintaining accurate documentation for clinical trials.
Highest-signal resume keywords
Study Start-Up (SSU) ExperienceICH-GCP GuidelinesRegulatory SubmissionsSite Contract NegotiationCTIS Submissions
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Study Start-Up ManagementRegulatory Documentation ProcessingSite Activation TrackingEthics Committee SubmissionsInformed Consent AdaptationTrial Master File MaintenanceFinancial ReconciliationClinical Study Reporting
Tools & Technologies
Company SystemsRepositories
Industry Keywords
Life SciencesClinical OperationsAudit ReadinessSite Feasibility AssessmentsMDR Submissions
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Competitive compensation package
- Comprehensive benefits
- Opportunity for personal and professional growth
- Collaborative and innovative work environment
- Home-based/fully remote work