Clinical Operations Manager

Reference Number: 895936-W
Type of placement: Contract, 12 months
Location: Switzerland, North West

Introduction:

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).

Main Responsibilities:

  • 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

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