Senior Manager Central Monitoring (RBQM) - home-based in US

Location: Princeton, NJ (08540)
Company: LabCorp
Industry: Science
Job Type: Full Time
Posted: 57 days ago
Reposted: 50 days ago
  • 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 supervisor


  • 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 eg 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 skills

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