Study Start-up Lead

Job not on LinkedIn

🔥 0 minutes ago

🇨🇭 Switzerland – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 12%

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Clinilabs

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2000

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Clinilabs is a global, full-service Contract Research Organization (CRO) specializing in the development of central nervous system (CNS) drugs, devices, and technology. The company provides comprehensive services to pharmaceutical, biotechnology, and medtech organizations, supporting their projects from first-in-human to Phase 3 clinical trials. Clinilabs is dedicated to addressing the significant unmet needs in CNS drug development, focusing on neurological, mental health, and substance use disorders.

📋 Description

• Lead and oversee the full lifecycle of regulatory submissions for global or regional clinical trials through last participant site activation • Ensure startup activities are delivered on time, within scope and budget, and in compliance with ICH/GCP guidelines, SOPs, and protocol requirements • Manage strategic startup planning and risk mitigation with the Study Project Manager • Oversee and coordinate SSU Specialists, serving as their initial point of contact and supporting site liaison activities • Train SSU Specialists on project-specific systems and procedures • Serve as subject matter expert for EU CTR and CTIS processes • Plan and execute Initial CTAs, Part I and Part II submissions, Substantial Modifications, and CTIS lifecycle activities • Oversee Requests for Information and ensure timely, high-quality responses • Provide expertise for end-of-study activities, including EoT notifications, Summary of Results, Lay Summary, CSR, and CSRr submissions • Maintain startup plans and timelines, track progress, and ensure milestones are achieved • Coordinate EC/IRB, regulatory, and protocol-related submissions and notifications • Ensure adaptation of Subject Information and Informed Consent documents to local requirements • Ensure startup documentation is submitted to the Trial Master File on time • Execute Greenlight forms and verify required approvals • Measure startup deliverables and metrics; update Project Managers and customers on progress and escalate issues • Support maintenance of site, country, and regional startup requirements databases • Support business development through capability presentations, bid defenses, and proposal strategy • Provide team-member performance feedback to Line Managers • Ensure compliance with EU CTR 536/2014, ICH-GCP, EMA guidance, and national requirements • Support audits and inspections • Contribute to SOPs, work instructions, and templates • Travel as required by studies, potentially globally

🎯 Requirements

• Bachelor’s or master’s degree in Life Sciences or related field • 3+ years’ experience working in global regulatory environment • EU CTR submissions experience; advanced CTIS expertise is required • CTIS system expertise is required • Strong understanding of EU CTR timelines, dossier content, and results reporting • Proven ability to lead complex submission programs • Experience in pharma, biotech, or CRO • Knowledge of ICH guidelines, Good Clinical Practice regulations, regulatory intelligence, and EU regulatory strategy • Strategic thinking with cross-functional leadership experience • Problem-solving and analytical skills • High attention to detail • Excellent communication and presentation skills in bid defense or customer meetings