• 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

Qualifications:

• 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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