CK Group are recruiting for a Clinical Operations Manager to join a growing biopharmaceutical company at their site based just outside of Basel, in Allschwil. The position is offered on a 12 month contract with the possibility of extension.
Clinical Operations Manager Role:
The main purpose of the role will be to:
- Drive 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
- Play a role in 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.
Further responsibilities will include:
- Leading the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables.
- Supervising 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).
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Bachelor of Science degree or equivalent university degree in Life Sciences or Healthcare.
- Previous 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).
This is an excellent opportunity to join a growing biopharmaceutical company. Apply:
For more information or to apply for this Clinical Operations Manager position, please contact Jocelyn Blackham on 0041 (0) 800 106 106 or email email@example.com, quoting job ref 51409.
Please could you send any correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.