Site Activation Manager / Specialist Switzerland
Syneos Health Switzerland GmbH
Site Activation Manager / Specialist Switzerland Job Responsibilities Accountable for performance and compliance for assigned protocols in Switzerland in compliance with ICH/GCP and country regulations, sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally. Responsible for budget/finance aspects, execution and oversight of clinical trial country submissions and approvals, and ensuring site readiness. Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). Oversees and tracks clinical research-related payments. Payment reconciliation at study close‑out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Executes and oversees clinical trial country submissions and approvals for assigned protocols. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with moderate oversight. Develops local language materials including local language informed consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols. Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country. Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country‑specific trial commitments and objectives especially during study start‑up. Qualifications Bachelor’s Degree 5–7 years of experience in Clinical Research and/or finance/business Detailed understanding of clinical trial process across Phases II–IV and ICH GCP. Ability to understand clinical protocols and associated study specifications. Detailed understanding of clinical trial start‑up processes. Strong organizational skills with ability to handle multiple tasks effectively. Strong written and verbal communication and interpersonal skills. Fluency in both German and English. Good negotiating skills and good problem‑solving skills. Able to work from the office in Lucerne on a regular basis. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. #J-18808-Ljbffr
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