Syneos Health has recently formed a new partnership with a leading pharmaceutical organization. Due to this new partnership, Syneos Health is seeking a Study Start-Up Project Delivery Lead to be fully outsourced and dedicated to this partnership. You will act as Clinical Operations Manager (COM) for the client and will be fully integrated in to a dynamic and friendly team.
This position is office-based in Lucerne in Switzerland.
- Being accountable for execution and oversight of local operational clinical trial activities in the Germany for assigned protocols in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Taking ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). Oversight and tracking of clinical research‐related payments. Payment reconciliation at study close‐out. Financial forecasting and maintenance of financial systems.
- Being responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Interactions with IRB/IEC and Regulatory Authority for assigned protocols.
- Coordinating and liaising with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Working closely with the CRD and local GCTO country operation to assess, prioritize and drive execution of specific clinical trials in order to support.
The ideal candidate will need the following experience / skills to be considered:
- Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent health Care related experience
- Skilled knowledge of local regulatory environment and submissions and approval processes, and understanding of how these impact study start‐up
- Able to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues
- Fluency in German language
- Good knowledge of French in written and spoken
- Problem solving is essential to this position
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.