Clinical Operations Manager
Alex Tosney 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 Alex Tosney on 0041 (0) 7825 08 443 or email email@example.com. Please quote reference 47113 in all correspondence.