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Sr. Manager Central Monitoring (RBQM)

Company: Labcorp
Location: Princeton
Posted on: January 27, 2023

Job Description:

  • Manage portfolio of Customer studies and act as a customer point of contact for the Central Monitoring activities
  • Prepares and provides Central Monitoring (Site, subject & study level review as applicable) proposal text and review of costing, contributes to proposal strategy and development.
  • Collaborates in the development of sponsor presentations/bid defense support.
  • Oversees at a study/customer level the appropriate tracking, interpretation and application of data to proactively manage risk
  • Leads, plans, prepares, conducts and follows up the central monitoring activities and supports less experienced team members
  • Plans and chairs detailed Risk Assessment meetings, oversees preparation of initial Risk Management Register, and distribution of Study Risk Impact Reports and assignment of Site Risk Weighting.
  • Ensures Critical Data & Process Definition are implemented in EDC design by Data Expert
  • Leads Site Risk Assessment across multiple studies, reviews site outreach, Pre-Study Visit reports, Site Risk Assessment, site risk stratification, advises on baseline site risk levels and confirms appropriate initial site monitoring intervention levels, aligned with monitoring strategy
  • Develops and establishes requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable Risk Factor trigger levels.
  • Reviews and approves the Central Monitoring plans and other applicable plans and any subsequent changes.
  • Ensures configuration of tools, risk factors trigger levels, programming of study specific risk factors and central monitoring parameters and coordinates user acceptance testing of tools
  • Performs initial dashboard reviews, recommends adjustments as required, supports and guides the team through ongoing reviews, escalates critical study issues to appropriate stakeholders.
  • Performs subject level and study level clinical reviews and take appropriate actions as applicable
  • Approves changes to monitoring levels, ensuring compliance with applicable Plans and sponsor needs are met.
  • Oversees Project Quality and Risk Reports to ensure client satisfaction and compliance.
  • Coaches assigned project teams internally and externally to increase the central monitoring competence.
  • Identifies and presents global strategic options and study challenges/opportunities with the client during proposal, bid defense and study implementation.
  • Demonstrates visible leadership to clients through effective problem solving and generation of customer solutions.
  • Collaborates with other team members to assess the impact of process improvements and either approve or refer upwards.
  • Contributes to the development and maintenance of processes, including SOP writing, process mapping and process improvements using Six Sigma and LEAN methodologies.
  • Any other duties assigned by supervisorQualifications:
    • University / college degree or post-graduation (life science preferred) from an appropriately accredited institution.
    • Minimum of 8-10 years of relevant clinical research experience in a pharmaceutical company/CRO or other equivalent experience with increasing levels of responsibility in clinical trial related roles e.g. project management, clinical monitoring, data management and informatics.
    • Experience in RBM (Risk Based Monitoring) or RBQM preferred
    • Good ability to work with/ to present to staff at all levels
    • Good influencing, negotiation and problem solving skills
    • Good leadership and chairing skills
    • Strong analytical skills, good detail focus and accuracy
    • Strong planning, time management and organizational skills
    • Strong project and risk management skillsLabcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our.Required
      Preferred
      Job Industries
      • Customer Service

Keywords: Labcorp, Trenton , Sr. Manager Central Monitoring (RBQM), Executive , Princeton, New Jersey

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