Clinical Operations Manager

  • Salary: Competitive
  • REF Number: 00046331
  • Consultant: Jasmin Baumgartner
  • Contact: +41 782 508 535
  • Date Published: 20.08.2019
  • Sector: Cardiovascular, Rare Diseases
  • Location: Basel Area
  • Discipline: Clinical - Clinical Operations

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.

For more information or to apply for this position, please contact Jasmin Baumgartner on 0041 (0) 782 508 535 or email jbaumgartner@ckqls.ch. Please quote reference 00046331 in all correspondence.

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