Regional Study Start-Up Lead
On-siteBaar, Zug, Switzerland
Job Summary
Lead day-to-day management of multiple projects or a multi-study program for site activation within your designated region. Drive site selection processes to ensure timely and efficient activation while overseeing site activation according to prescribed timelines and quality standards. Act as a subject matter expert in EUCTR, ensuring timely collection of Part 2 documents, and coordinate SSU specialists across regions to keep sites on track with the critical path. Serve as an escalation point for regulatory and vendor setup issues, monitor project status, and provide metrics to the Study Start-up Oversight Lead. Manage EC submission strategies, including patient-facing materials and Informed Consent Form timelines, and ensure operational readiness for site activation through collaboration with CML. Facilitate knowledge transfers across countries and resolve issues to ensure activation activities adhere to the agreed plan.
Required Qualifications
- Expert knowledge in EUCTR and APAC regions
- Bachelor's Degree in life sciences or equivalent (e.g., pharmacy, nursing)
- Minimum of 8 years of clinical trial experience
- At least 5 years in a study start-up role
- At least 3 years at a regional level
- Previous experience in a Contract Research Organization (CRO) is essential
- Strong EUCTR experience – previously involved in submissions
- Experience of start up in APAC region
- Proven experience in project management and site activation
- Strong communication, organizational, and leadership skills
- Proactive mindset with the ability to identify bottlenecks and propose solutions
- Ability to manage multiple projects, coordinate cross-functional teams, and work in a matrix environment
- Proven ability to handle a high volume of tasks of varying complexity and effectively utilize escalation pathways
- Excellent communication skills (listening, oral, written) in English
- Comfortable using CTMS, eTMF, Veeva, and Microsoft Project
Desired Qualifications
- Familiarity with regional regulatory processes and requirements
- Experience in leading cross-functional teams effectively
- Advanced proficiency in project management tools
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