Study Start-up Lead

This is a fully remote position, open to applicants in Switzerland.

📋 Description

• Lead and manage the entire lifecycle of regulatory submissions for global or regional clinical trials until the activation of the last participant site.

• Ensure that startup activities are completed punctually, within the defined scope and budget, while adhering to ICH/GCP guidelines, SOPs, and protocol specifications.

• Collaborate with the Study Project Manager to strategize startup planning and risk mitigation.

• Supervise and coordinate SSU Specialists, acting as their primary contact and aiding in site liaison activities.

• Provide training to SSU Specialists on project-specific systems and procedures.

• Act as a subject matter expert for EU CTR and CTIS processes.

• Plan and implement Initial CTAs, Part I and Part II submissions, Substantial Modifications, and CTIS lifecycle activities.

• Oversee Requests for Information, ensuring timely and high-quality responses.

• Offer expertise for end-of-study tasks, which include EoT notifications, Summary of Results, Lay Summary, CSR, and CSRr submissions.

• Maintain startup plans and timelines, monitor progress, and ensure milestones are met.

• Coordinate submissions and notifications related to EC/IRB, regulatory, and protocols.

• Ensure that Subject Information and Informed Consent documents are adapted to meet local requirements.

• Guarantee timely submission of startup documentation to the Trial Master File.

• Execute Greenlight forms and confirm required approvals.

• Assess startup deliverables and metrics; update Project Managers and clients on progress while escalating issues as necessary.

• Assist in maintaining databases for site, country, and regional startup requirements.

• Support business development through capability presentations, bid defenses, and proposal strategies.

• Provide performance feedback on team members to Line Managers.

• Ensure compliance with EU CTR 536/2014, ICH-GCP, EMA guidelines, and national regulations.

• Assist during audits and inspections.

• Contribute to the development of SOPs, work instructions, and templates.

• Travel as needed for studies, potentially on a global scale.

⛳️ Requirements

• Bachelor’s or master’s degree in Life Sciences or a related field.

• Over 3 years of experience in a global regulatory environment.

• Experience with EU CTR submissions; advanced expertise in CTIS is essential.

• Proficiency in the CTIS system is required.

• Strong knowledge of EU CTR timelines, dossier content, and results reporting.

• Demonstrated ability to lead complex submission programs.

• Background in the pharmaceutical, biotech, or CRO sectors.

• Familiarity with ICH guidelines, Good Clinical Practice regulations, regulatory intelligence, and EU regulatory strategy.

• Strategic thinking skills combined with cross-functional leadership experience.

• Strong problem-solving and analytical abilities.

• High level of attention to detail.

• Excellent communication and presentation skills for bid defenses or customer meetings.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and growth.

• Dynamic and supportive work environment.

• Flexible working arrangements and potential remote work options.