Job Overview :
Are you ready to discover you next career at Labcorp Drug Development?
A career at Labcorp provides our employees the unique chance to create an immediate impact and difference in our patient’s lives.
will offer a rewarding career, a chance to work in an energetic & team oriented work place, and access to competitive benefits.
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Labcorp is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
We are recruiting for our Team in Latin America and we are looking for a Central Monitoring Manager based in Latin America
Individual Contributor Role not a Line Manager
Performs the Central monitoring activities for multiple studies and ensure accurate tracking and status reporting of studies in his / her remit.
Manage portfolio of studies for a Customer and act as a customer point of contact
Collaborates in the development Central Monitoring 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
Ensures that tracking and status reporting are performed in a timely and accurate manner. Applies data to recommend any required changes
Leads, plans, prepares, conducts and follows up the central monitoring (Site, subject & study level review as applicable) activities and supports less experienced team members
Supports PMO in preparation of initial Risk Management Register and may prepare, distribute and follow up Study Risk Impact Reports and coordinate Site Risk Weighting.
Ensures Critical Data & Process Definition are implemented in EDC design by Data Expert
Conducts Site Risk Assessment across multiple studies, works with study start up team members, reviews site outreach, Pre-Study Visit reports and Site Risk Assessment.
Prepares site risk stratifications and proposes baseline site risk levels and initial site monitoring intervention levels
Develops and establishes requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable Risk Factor trigger levels.
Develop the Central Monitoring and other applicable plans and any subsequent changes.
Manages configuration of tools, risk factors trigger levels, programming of study specific risk factors and central monitoring parameters and performs user acceptance testing of applicable tools
Performs ongoing dashboard reviews, prepares and recommends mitigation actions and reviews recommended monitoring levels with project team and ensures that identified issues are followed to resolution
Agrees potential changes to monitoring intervention level with project team in line with the applicable plans, and escalates appropriately.
Performs subject clinical reviews and take appropriate actions as applicable
Performs study analytics reviews as per the applicable plans and communicate the findings appropriately
Reviews and 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.
Contributes to the development and maintenance of processes, including SOP writing, process mapping and process improvements using Six Sigma and LEAN methodologies.
Evaluates and collates process improvement suggestions and submits to leadership.
Evaluates and submits ideas and justification for improved systems and tools to leadership.
Any other duties assigned by supervisor
Education / Qualifications :
University / college degree or post-graduation (life science preferred) from an appropriately accredited institution.
Minimum of 7-9 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.