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.