Junior Clinical Operations Manager (897538 – SLV)
- Experience Level
- Experienced (non-manager)
Our client is an innovative mid-size Pharmaceutical company with global headquarters in the German speaking part of Switzerland. A well-funded and stable organisation, our client enjoys the backing of a number of leading, globally recognised institutions. They currently market 3 leading products in anti-infective and oncology via a global alliances and extensive partner network. We have a long standing relationship with this company and have placed a number of key people in the organisation in the past, all of whom have given us some great feedback from their time working there.
We are currently looking for Junior Clinical Operations Manager for a 12 x month contract to be based in Basel.
Reporting directly to the Clinical Operations Global Program Manager, your focus is to support clinical trial activities (global phase II and phase III trials) in close collaboration with the Senior Clinical Operations Manager and to conduct an oversight of CROs and other vendors.
- Operational support with start-up activities of study sites;
- Plan and manage meetings with CROs and vendors;
- Manage and oversee CRO and other vendors for selected deliverables;
- Support Senior COM with the preparation of forecasts and status reports;
- Effective collaboration with other internal functions such as Clinical Supplies, Pharmacovigilance, Clinical Quality Assurance, Legal;
- Review and/or prepare trial related documents (manuals, plans, guidelines, visit reports, newsletters);
- Support set-up of relevant systems for clinical trials such as EDC, IRT, eTMF, Centralized Monitoring Platform, RACT;
- Function as a Risk Review Coordinator for some quality management software (Cluepoint);
- Set-up, maintenance and quality check of eTMF.
Qualifications and Experience:
- Minimum of 2 year experience as a Lead CRA or Clinical Trial Manager of phase II – III;
- Previous CRO and/or pharmaceutical industry experience preferentially in oncology;
- CRA experience in oncology is a plus;
- Solid understanding of operations on global multi-center trials;
- Robust knowledge of ICH-GCP and clinical trial regulations;
- Excellent team working skills in international and cross-functional environment;
- Fluent in English, knowledge of German is a plus;
- Relevant working/residency permit or Swiss/EU-Citizenship required.