Clinical Operations Manager

Hobson Prior are looking for a Clinical Operations Manager to join a growing biopharmaceutical company in Switzerland who focus on discovering, developing and bringing more, pioneering medicines to patients.

Job Responsibilities:

• Drive 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.
• Manage 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, timely completion of electronic Case report Form, Source Data verification progress and query responses timelines.
• Lead the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables.
• Manage the selection of ESPs in collaboration with other functions.
• Supervise the deliverables towards the Contract Research Organization 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.
• Manage 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.
• Represent as the communication channel for the Clinical Research Associates to ensure data quality is maintained, in close collaboration with other CTT functions
• Approve invoices and ensure related payments in a timely manner.
• Contribute to the Study Master File completeness and readiness for audit/inspection and by performing ongoing quality checks/review.
• Actively partake to Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary.

Key Skills:

• Strong computer skills including proficiency in Microsoft (MS)-based applications.
• Strong verbal and written communication skills in English; strong cultural knowledge of national diversities.
• Excellent interpersonal, communication (written and verbal), collaboration and organizational skills.
• Self-motivated and able to work independently and proactively.
• Goal-oriented, able to effectively prioritize and execute tasks in a high-pressure environment.
• Demonstrate ownership and initiative, decision-making, working flexibility and problem-solving skills.

Requirements:

• Bachelor of Science degree or equivalent University degree in life sciences or healthcare.
• A minimum of 4 years 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.
• Prior experience as a CRA.
• Previous experience working with electronic data capture, electronic Trial Master File, and Clinical Trial Management Systems.
• Excellent knowledge of International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines.
• Position may require international travel.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.