Description
We are looking for a
Clinical Study Manager (m/f)
Reference: -en
Start: asap
Duration: 24 MM
Place: in Neuchatel
Branch: Tabakverarbeitung
Your tasks:
- Accountable for planning of activities, monitoring of the progress and coordination and supervision of the CROs (Clinical Research Organisation), investigational sites, labs and other external/internal stakeholders involved in the study execution
- Monitor Phase I and Phase II
- Manage the Clinical Study Team and all operational aspects of assigned clinical studies
- Coordinate the preparation of study-related documents (e.g. protocol outlines, protocols, informed consent forms, diary case record forms, study report etc.)
- Ensure timely delivery and reviews of documents generated by external parties
- Contribution to above mentioned documents (input, reviews, quality checks)
- Responsible for strict supervision of monitoring activities (conducted by CROs monitors) including definition of monitoring plans, review of monitoring reports, follow-up letters and co-monitoring visits
- Ensure that studies are executed with full adherence to ICH GCP, Declaration of Helsinki and any relevant guidelines and regulations
- Responsible for the collection and of essential documents and completeness of Study Master Files
- Contribute to the Quality Control of all deliverables received from CROs & investigators
- Maintain up-to-date knowledge of GCPs and relevant regulations and support clinical assessment group in revision/preparation of selected SOPs and document templates
Your qualifications
- Profound experience in the management of clinical studies, clinical trial monitoring in a pharmaceutical company or a CRO
- Previous experience in executing studies in the EU, especially in Poland
- Previous experience in dealing with 2-3 studies in parallel
- Previous experience in quality assurance/quality control is an asset
- Fluency in English
Skills:
- Clinical project manager
Keywords: Clinical Project Manager Phase I Phase II CRO ICH GCP