Clinical Operations Manager
CK Clinical
Basel, Switzerland
vor 12 Std.
source : PharmiWeb.com

Jasmin Baumgartner is recruiting for a Clinical Operations Manager to join a company in the pharmaceutical industry at their site based in Basel on a one-

year contract basis. Our client works with multiple targeted diseases taking an innovative approach with a specialism in the discovery and development of small molecules.

The main purpose of the role will be : · 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.

    To succeed in this role, you will have : - Bachelor of Science degree or equivalent University degree in life sciences or healthcare.

  • 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 as a CRA. - Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS).
  • Excellent knowledge of International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines. Please quote reference 46331 in all correspondence.
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