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Global Clinical Operations ManagerRef: mc25195


Added:16 Oct 2020

Region: Europe

Sector: Pharmaceutical

Sub Sector: Clinical Research

Job Responsibilities

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.

  • 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

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 (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
* Position may require international travel

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