Hobson Prior is seeking a Clinical Operations Manager for a contract position based in Allschwill. The successful candidate will be responsible for driving the development of operational trial-related documents and procedures, as well as managing External Service Providers (ESPs) and supervising their deliverables. This role may require international travel.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

• Manage operational trial-related activities 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, and submissions to Ethics Committees/Institutional Review Boards (ECs/IRBs).
• Lead the development of ESP specifications, testing and implementation, 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.
• Lead the development of trial-related operational documents.
• 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.
• 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.
• Actively participate in Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary.
• Mentor team members as needed.

Requirements

• Bachelor of Science degree or equivalent University degree in life sciences or healthcare.
• 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.
• 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.
• Strong 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.
• Demonstrate ability to work in multi-functional and cross-functional teams: effective teamwork and collaborative relationships.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.

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