Senior Study Start Up & Regulatory Specialist
- Experience Level
- Experienced (non-manager)
Hobson Prior are currently seeking a Senior Study Start Up & Regulatory Specialist to join a leading biopharmaceutical company who bring clinical and commercial work together to enable a better, smarter and faster way of bringing biopharmaceutical products to the market.
- Accountable for the execution and oversight of local operational clinical trial activities 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.
- Responsible for the 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.
- Development, negotiation and completion of Clinical Trial Research Agreements.
- Oversight and tracking of clinical research related payments. Payment reconciliation at study close out and financial forecasting and maintenance of financial systems.
- Co-operating with the CRD and local GCTO country operation to assess, prioritize and drive execution of specific clinical trials in order to support.
- 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.
- Ablility to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues.
- Problem solving is essential.
- Excellent communication skills.
- Fluency in German and English language.
- 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.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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