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Senior Trial Manager

New Jersey All, NJ

Post Date: 11/16/2017 Job ID: JN -112017-20436 Job Type: Clinical Project Management - Clinical
  • Contribute to all operational trial deliverables
  • Development of specific sections of the protocol and related documents
  • Development of study tools, guidelines and training materials
  • Organization and logistics of various trial advisory committees (e.g. Data Monitoring Committee, Steering Committee)
  • Ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries)
  • Supporting forecast and management of drug supply for and comparator drug products in collaboration with internal stakeholders
  • Contributing to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs)
  • Manage interface with CROs in cooperation with outsourcing management and line functions; ensuring vendors meet quality standards; contributing to the development/amendment of vendor contracts
  • Contribute to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and clinical development representative
  • Implementing issue resolution plans
  • Acting as point of contact for all site-related issues and procedural questions
  • Managing interactions with relevant line functions including data management, drug supply management, clinical development and Country Pharma Organizations
  • Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation
  • Supports the Global Trial Director with the development, management and tracking of the trial level life cycle budget incl forecast, and annual cost targets
  • Core member of the global cross-functional Clinical Trial Team (CTT)
  • Participate and report study progress and issues/resolution plan at the CTT meeting
  • Write CTT meeting minutes
  • Organize and chair trial sub teams within the scope of his/her delegated responsibilities
  • Extended member of the Global Clinical Team (GCT)
  • As member of the CTT, contribute to defining the Data Review Plan; participate in data review as specified in the Data Review Plan
  • May contribute to talent development through active participation in onboarding and training activities
  • May participate in GDO Trial Management initiatives and working groups
  • Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and franchise, including sharing lessons learned

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