Clinical Operations Manager

An experienced Clinical Operations Manager with experience in Cardiovascular studies is required to join a Swiss based pharmaceutical company on a 12 month contract. This is a hybrid role with a requirement to work onsite part of the week. Please only apply if you are an EU/EFTA citizen or hold a valid Swiss Work Permit.

Responsibilities:

• Managing the operational trial related activities in close collaboration with other functions, such as: 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
• 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 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 collaboration with other CTT 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
• Actively participate to Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary

Candidate requirements:

• At least 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 (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)
• Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines
• Experience within the cardiovascular therapeutic area preferred.

For additional information and a confidential discussion, please apply now with an updated CV.