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Risk Based Monitoring Lead
at Vertex
Boston, MA

Risk Based Monitoring Lead
at Vertex
Boston, MA

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Description

Job Description:

GENERAL POSITION SUMMARY:
The Risk Based Monitoring (RBM) Lead role within Clinical Data Management is responsible for timely and high quality risk-based monitoring analytics supporting the Vertex portfolio. This management level role will support an approach to clinical trial monitoring which utilizes data and site level information to determine needs for performing on-site, remote and centralized activities and focuses resources on risks that have the most potential to impact patients' safety and data quality.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
  • Refer to the Key Responsibilities section

KEY RESPONSIBILITIES:
  • Implements global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
  • Develops, maintains and oversees the Adaptive Monitoring processes
  • Develops standards including tools / templates for adaptive monitoring activities
  • Trains Central Risk Managers and Study Risk Review Team members on processes, tools and templates
  • Provides guidance / advice to Study Risk Review Team as needed
  • Provides technical expertise to set up and test study level Risk-based Monitoring system for all Vertex studies.
  • Reviews program level system outputs to process for the signal and action management
  • Completes periodic portfolio level risk review with functional area representatives to identify enterprise-level trends, corrective actions, etc.
  • Able to resolve conflicts, influence and communicate cross-functionally with key stakeholders and customers.
  • Functional / line management of Central Risk Managers
  • Performs other duties as assigned

TECHNICAL AND COMMUNICATIVE SKILLS:
  • Technical expertise and business experience in supporting clinical trials database development, data management, site monitoring, etc.
  • Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
  • Project management skills and technical capabilities as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
  • Works independently, receives instruction primarily on unusual situations
  • Ability to organize tasks, time and priorities; ability to multi-task
  • Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally
  • Must have experience with data visualization and data analytics tools


Qualification:

  • B.S. (or equivalent degree) and 8-10 years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background
  • Prefer minimum of 3-4 year experience of working in centralized monitoring/RBM.
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