Clinical Operations Manager
CK Group are recruiting for a Clinical Operations Manager to join a Swiss high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options.
The position will be for a 12-month contract, located near at the clients office near Basel, the rate for this role will be 69.49 CHF per hour.
The Clinical Operations Manager is drivingthe 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.
- Lead the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control ofdeliverables
- 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
- Consolidate information on operational clinical trial level activities for reporting to the CTT by the Senior Clinical Operations Manager (including critical issues and key performance indicators)
- Resolve operational issues in a proactive and timely fashion
- Act as the communication channel for the Clinical Research Associates (CRAs) to ensure data quality is maintained, in close collaborationwith other CTT functions
- Bachelor of Science degree or equivalent University degree in life sciences or healthcare
- 4 years of 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 and multicultural teams
- Experience in selecting and managing External Service Providers , includingperformance assessments and finance management
- Previous experience working with electronic data capture, electronic Trial Master File, and Clinical Trial Management Systems
- Excellent knowledge of International Conference on Harmonization-GoodClinical Practice (ICH-GCP) guidelines
- Strong computer skills including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint)
- Excellent verbal and written communication skills in English; strong cultural knowledge of national diversities
Please quote job reference 56603 in all correspondence. Applicants need full rights to work in Switzerland