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Clinical Operations Manager

Website Achieva Group Limited

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, etc.
  • Manage the selection of ESPs in collaboration with other functions
  • Supervise the deliverables towards the Contract Research Organization (CRO) and ESPs selected for the trial
  • 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
  • Resolve operational issues in a proactive and timely fashion
  • Approve invoices (e.g. site payments) and ensure related payments in a timely manner
  • 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 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
  • Position may require international travel

 

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