Job Title: Clinical Operations Manager
Location: Switzerland
Schedule: Full-time
Duration: 12 months
Job Responsibilities:
Lead the development of trial-related documents, procedures, and oversee ESP activities from specifications to close-out.
Manage operational activities including site initiation/closure, import/export licenses, eTMF setup/maintenance, contracts, invoicing, regulatory submissions, eCRF completion, SDV, and query responses.
Collaborate with teams to select ESPs and ensure quality control of deliverables.
Supervise ESP deliverables to ensure compliance with study protocols and scope of work, escalating issues to the Clinical Trial Team (CTT).
Develop trial-related operational documents and report critical issues and KPIs to the CTT.
Resolve operational issues promptly and maintain communication with CRAs to ensure data quality.
Approve site payments and contribute to Study Master File (StMF) readiness for audits.
Participate in investigator meetings, site selection, and initiation visits.
Mentor team members and take on additional project-related duties as assigned.
Candidate Requirements:
Bachelor's degree in life sciences or healthcare.
4+ years of experience in managing operational aspects of Phase II and III trials.
Experience in global, cross-functional teams and ESP management.
Familiar with eTMF, electronic data capture, CTMS, and ICH-GCP guidelines.
Proficient in English, with cultural awareness and communication skills.
Ability to travel internationally if needed.
Behavioral Skills:
Strong communication, collaboration, and organizational skills.
Self-motivated, goal-oriented, and able to prioritize in high-pressure situations.
Proactive, with strong problem-solving and decision-making abilities.
Effective teamwork and the ability to mentor others.
Seniority level Mid-Senior level
Employment type Contract
Job function Science
#J-18808-Ljbffr