Clinical Operations Manager 6460 URA

 

Our client is headquartered in Switzerland – a biotech-hub of Europe – is a 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 is looking a Clinical Operations Manager for a initial 12 months contract based in Basel.

 

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.

 

Main Responsibilities:

·       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 (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.

·       Mentor TEAM MEMBERS as needed.

·       Assume responsibility for other project or trial-related duties as assigned.

 

Qualifications and Experience:

 

  • Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;

·       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 (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 Harmonisation-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.

·       Position may require international travel.

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