Contract Clinical Operations Manager

vor 1 Monat

Basel, Schweiz Pharmiweb Vollzeit

RBW Consulting are partnering with a leading Biopharmaceutical organisation in their search for a Contract Clinical Operations Manager in Switzerland. This company discovers, develops, and commercializes medicines across a wide variety of therapeutic areas.

This role will be a 12 month, 1 FTE contract and you will be required in the office in Allschwil, Switzerland.

Job Responsibilities

The Clinical Operations Manager is driving the development of the operational trial related documents and procedures, as well as setting-up the ESPs and supervising the deliverables of all ESP related activities, from specifications to close-out. For large Phase III or complicated trials, several Clinical Operations Managers might be assigned to a trial for the management of ESPs.

  • Manage 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, submissions to Health Authorities, submissions to Ethics Committees/Institutional Review Boards (ECs/IRBs), timely completion of electronic Case Report Forms (eCRFs), Source Data verification (SDV) progress and query responses timelines
  • Manage the selection of ESPs in collaboration with other functions
  • Lead the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables
  • Supervise 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 the Clinical Trial team (CTT)
  • Lead the development of trial-related operational documents
  • Consolidate information on operational clinical trial level activities for reporting to the CTT by the Senior Clinical Operations Manager (including critical issues and key performance indicators)
  • Resolve operational issues in a proactive and timely fashion
  • Act as the communication channel for the Clinical Research Associates (CRAs) to ensure data quality is maintained, in close collaboration with other CTT functions
  • Approve invoices (e.g. site payments) and ensure related payments in a timely manner
  • Contribute to the Study Master File (StMF) completeness and readiness for audit/inspection and by performing ongoing quality checks/review
  • Actively participate to Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary
  • Assume responsibility for other project or trial-related duties as assigned

Candidate's Requirements

  • Bachelor of Science degree or equivalent University degree in life sciences or healthcare
  • 4 years of experience in managing operational aspects of Phase II and Phase III trials and executing a wide range of clinical trial activities from study start up to clinical study report
  • Experience in working in global cross-functional (matrix) and multicultural teams
  • Experience in selecting and managing External Service Providers (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)
  • Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines
  • Strong computer skills including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint)
  • Excellent verbal and written communication skills in English; strong cultural knowledge of national diversities
  • Position may require international travel

Apply here to find out more

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