Clinical Operations Manager
Clinical Operations Manager
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1 Vacancy
Job Description
Location: Basel
Salary: Up to 79.00 CHF per hour
CK QLS 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:
- 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 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 (CR O) 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).
Your Background:
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:
Please could you send any correspondence in English. Please quote job reference 128 999 in all correspondence.
It is essential that applicants hold entitlement to work in Switzerland.
Employment Type
4
