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 the clients office near Basel, the rate for this role will be 69.49 CHF per hour.

Job Responsibilities:

The Clinical Operations Manager is driving 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. 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 of deliverables.
• 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 th e 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 criti cal 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 collaboration with other CTT functions.

Candidate’s Requirements:

• 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 exe cuting 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, including performance 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-Good Clinical 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 knowle dge of national diversities.

Apply:

Please quote job reference 106192 in all correspondence. Applicants need full rights to work in Switzerland.