Clinical Operations Manager

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.

• Strong computer skills (MS Word, Excel, PowerPoint).

• 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.