ProClinical is currently recruiting for a SSU and Regulatory job in Germany. This company is a multinational medical device manufacturer and a leader in the innovation of biomaterials, including implants, instruments and other orthopaedic technologies.
- 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.
Skills and Requirements
- Prior experience within working on European regulatory approvals
- Working on regulatory approvals within
- Strong project management experience, capable of managing a team across the globe
- Experience within biologics / antibodies (nice to have)
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.