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Senior Trial Operations Manager

New Jersey All, NJ

Posted: 12/02/2019 Job Type: Clinical Job Number: JN -122019-26058 Region: New Jersey All

Job Description

  • Accountable for the oversight and coordination of the global Monitoring operational aspects of assigned clinical trials with particular focus on pivotal trials, from start-up to close-out
  • Scope of activities range from trial start-up to close-out including strategic and operational planning, feasibility assessment, trial allocation, start-up activities coordination, patient recruitment, clinical data collection and delivery of timely, high quality submission data, sites close-out, audit organization and inspection preparation activities
  • Contribute to the implementation of the Trial Monitoring strategy in the assigned clinical trials
  • Communicates planned milestones to Trial Monitoring stakeholders and updates study teams on operational activities
  • Participate in the development of innovative solutions in clinical trial planning and execution, including country, site and patient engagement to ensure the delivery of assigned studies on time
  • Provides ongoing information and regular updates to the Trial Monitoring organization, including remediation actions
  • Participates to the development of reporting methodologies, and implements performance reporting for trial monitoring, ensures accurate and complete of operational data within corporate systems
  • Responsible to have trials execution according to enrolment commitment and timelines delivered per established key performance indicators
  • Develops planning for prospective management of clinical trials including operational risks for each phase of the trial (Feasibility/allocation, Start-up, Data collection and cleaning) using available internal and external resources (patients' incidence, competitive landscape regional strategies, data, statistical plan)
  • Drives conduct of medical and operational feasibilities and communicates aggregated feedback to clinical teams; supports protocol development based on the feasibility feedback collected, ensures feedback given during feasibility process is answered and provided to regions
  • Evaluates potential challenges/risks within the protocol and operational aspects of the study
  • Assesses impacts, develops risk management plans and communicates/escalates, as appropriate
  • Leads trial allocation process to ensure adequate patient accessibility and alignment with regional and country strategies, including re-allocation or corrective action when needed

Skills:

  • Bachelor s degree is required
  • At least 8 years of clinical research experience including the planning, executing and monitoring of clinical trials
  • Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
  • Demonstrated ability to collaborate across partner functions in a matrix environment
  • Project/Trial Management and CRA/Monitoring experience is required
  • Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision
  • Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues
  • Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations, and clinical development process
  • Excellent negotiation and conflict resolution skills
  • Demonstrated ability to influence without direct authority
  • Strong interpersonal skills
  • Excellent organizational, interpersonal skills with extensive networking
  • Communicates effectively with senior leaders in a local/regional/global matrixed environment


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