Clinical Operations Manager

Vor 3 Tagen

Allschwil, Schweiz CK Group Vollzeit

**Salary**:CHF 69.49 per hour
- **REF Number**:00056603
- **Consultant**:Robert Angrave
- **Contact**:01246 457731
- **Date Published**:09.02.2024
- **Sector**:Pharmaceutical, Clinical Research
- **Location**:Allschwil, Switzerland
- **Discipline**:Clinical Operations

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.

Job Responsibilities:
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
- Excellent verbal and written communication skills in English; strong cultural knowledge of national diversities

Apply:
Please quote job reference 56603 in all correspondence. Applicants need full rights to work in Switzerland

Rob Angrave

**Clinical Research Manager**

T: 01246 457716

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