Clinical Operations Manager

vor 1 Tag

Bern, Bern, Schweiz Pharmiweb Vollzeit
Job Title: Clinical Operations Manager

We are seeking a highly skilled Clinical Operations Manager to join our team in Switzerland. As a Clinical Operations Manager, you will be responsible for driving the development of operational trial-related documents and procedures, as well as setting up and supervising the deliverables of all External Service Provider (ESP) related activities.

Key Responsibilities:
  • Manage operational trial-related activities in close collaboration with other functions, including 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
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

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