Clinical Operations Manager

Conteúdo do emprego

A current vacancy as a Clinical Operations Manager with a leading pharmaceutical company is available in Switzerland.

Our client is looking for candidates based in Switzerland / EU passport holder for a 12-month, full time contract.

The perfect candidate is someone who has experience in managing operational aspects of Phase II and Phase III clinical trials and has executed a wide range of clinical trial activities from study start up to clinical study report. This person will have the ability to demonstrate strong interpersonal, communication, collaboration, and organisational skills.

Main Responsibilities

• Manage the operational trial related activities in close collaboration with other functions, such as
• Manage the selection of external service providers in collaboration with other functions
• Lead the development of external service provider 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 external service providers 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
• Lead the development of trial-related operational documents
• Consolidate information on operational clinical trial level activities for reporting to the clinical trial team by the Senior Clinical Operations Manager
• Act as the communication channel for the Clinical Research Associates (CRAs) to ensure data quality is maintained, in close collaboration with other clinical trial team functions
• Approve invoices (e.g. site payments) and ensure related payments in a timely manner
• Contribute to the Study Master File (StMF) completeness and readiness for audit/inspection and by performing ongoing quality checks/review
  

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 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, including performance assessments and finance management
• Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS)
• 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 knowledge of national diversities