Clinical Operations Manager
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Hobson Prior are currently working with a global CRO who are looking for a Clinical Operations Manager for a sponsor-dedicated role, this position is office based in Haar near Munich.
- You will be responsible for the 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.
- Take ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements.
- Accountable for the execution and oversight of clinical trial country submissions and approvals for assigned protocols.
- Oversight and tracking of clinical research related payments. Payment reconciliation at study close out. Financial forecasting and maintenance of financial systems.
- 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.
- You will work closely with the CRD and local GCTO country operation to assess, prioritize and drive execution of specific clinical trials in order to support.
- Submission experience in Germany.
- At least 1.5 year of experience with the EC submission (preparing and collecting all the essential documents for the submission).
- Experience with the local RA and EC .
- Experience with the contract preparation will be an asset.
- German and English skills are required as this person will be in charge of translating the study documentation from English into German.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
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