Clinical Operations Manager
Our client is a dynamic biopharmaceutical company looking for a Clinical Operations Manager for a 12 months contract based in the Basel area, Switzerland. The ideal candidate should have 5 years of previous experience performing international clinical trial management with emphasis in phase II-III and vendor management (i.e. CRO, central labs).
- Contributes to the operational trial related activities in close collaboration with other functions, such as: site initiations, site closures, import/export licenses for materials and IMP, eTMF set-up and maintenance, contracts execution and invoices, ESPs/Clinical research organizations selection and management, submissions to Health Authorities and IECs/IRBs, eCRF completion by sites and SDV status, etc
- Manages the selection of ESPs in collaboration with other functions
- Supervises the deliverables towards the Contract Research Organization (CRO) and ESPs selected for the trial, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Trial Team (CTT)
- Leads the development of trial-related operational documents
- Consolidates information on operational clinical trial level activities for reporting to the CTT by the Sr Clinical Operations Manager (including critical issues and key performance indicators).
- Ensures Study Master File (StMF) completeness for audit/inspection readiness and contributes by performing ongoing quality checks/review
- Actively participates to Investigators meeting preparation and presentations and in Site Selection Visits (SSVs) and Site Initiation Visits (SIVs), as necessary
Qualifications and Experience:
- Bachelor of Science degree or equivalent University degree in life sciences or healthcare
- 5 years of experience in managing operational aspects of Phase II and III trials and executing a wide range of clinical trial activities from study start up to clinical study report
- Experience in selecting and managing ESP, including performance assessments and finance management
- Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS)
- Relevant working/residency permit or Swiss/EU-Citizenship required