Clinical Operations Manager
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:
- 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 arole 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).
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 ExternalService 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 firstname.lastname@example.org, quoting job ref 53861.
Please could you send any correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.