Study Start-Up & Regulatory Specialist / Lead

Syneos Health has recently formed a new partnershipwith a leading pharmaceutical organization. Due to this new partnership, SyneosHealth is seeking a Study Start-Up &Regulatory Specialist/ ProjectDelivery Lead to be fully outsourced and dedicated to thispartnership. You will act as Clinical Operations Manager (COM) forthe client and will be fully integrated in to a dynamic and friendly team.

This position is office-based in Haar near Munich withthe possibility of 1 home-based day.

Job details:

• 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

Qualifications

The ideal candidate will need the following experience /skills to be considered:

• Bachelor's Degree of Life Science or equivalent health care
• Experience of the submissions and approval processes
• Contract negotiation background will be preferred
• Able to indirectly influence investigators, vendors and external partners
• Fluency in German and English language
• Problem solving is essential to this position

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