Central Monitoring Manager (individual contributor)
Covance Inc
Lima, Peru
hace 6 días

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.

With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

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.
  • Experience :

  • 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.

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