Study Start Up &Regulatory Specialist / COM- Sponsor Dedicated, Munich in Germany

Germany (DE)
60-70,000 Euro
20 Sep 2019
20 Oct 2019
Full Time
Permanent
Experienced (non-manager)

Syneos Health has recently formed a new partnership with a leading pharmaceutical organization. Due to this new partnership, Syneos Health is seeking a Sr SSU & Regulatory Specialist 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.

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.

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 budget and contract negotiations, 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.
  • Problem solving is essential to this position
  • Excellent communication skills
  • Fluency in German and English language


 
 

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