Covance

Head of Data Management

IN
Job Number
2017-14928
Job Category
Clinical Operations
Position Type
Full-Time

Job Overview

  • Formulate short-term and long-term strategies to improve regional data management efficiencies, through collaboration with senior management
  • Act as an advisor to manage and collaborate with the Services Center leadership (Project Management, Monitoring, Site Support, Biometrics, Drug Safety, Regulatory, etc.) on all data management aspects of projects with data components
  • Identify and implement solutions to regional data management issues and concerns, including proactive prevention strategies based on metrics and forecasts
  • Supervise, mentor and evaluate performances of data managers in regional locations and aide in staff development, career development, interpersonal skills, and achievement of competency standards
  • Provide expertise  and advice to project teams  for the development of Global Data Management  Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data
  • Support project teams and regionally-based project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget
  • Oversee regional data management services project budgets including revenue / expense forecasts and tracking
  • Collaborate with peers to establish global  data management competency models and assist with the development of training programs and ensure staff achievement of position competencies
  • Responsibility with peers for the global standardization of data management processes and process improvement and efficiency and for ensuring standards are applied in regional locations
  • Collaborate with peers to develop global, harmonized SOPs and specific quality processes and procedures for data management activities
  • Identify and implement process improvement solutions
  • Support business development and marketing activities at client presentations and professional seminars
  • Establish and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary
  • Manage utilization and billability of regionally-based lead data managers, planning for resource allocation / recruitment based on individual skills, competencies, and availability
  • Ensure revenue and operating margin performance of the regional data management group to agreed targets
  • Propose advice and support to business development for time and cost estimates and prepare and present to potential clients on global data management capabilities
  • Review literature and research technologies / procedures for improving global data management practices
  • Perform other duties as assigned by management

Education/Qualifications

Minimum  Required

  • University / college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing certification, medical or laboratory technology)
  • Broad knowledge of drug development process
  • Understanding of global clinical development budgets and relationships to productivity targets
  • Thorough knowledge of effective clinical data management practices
  • Thorough knowledge of time and cost estimate development and pricing strategies
  • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data  handling  and processing

 

Preferred

  • Masters or other advanced degree
  • Thorough knowledge of Covance sales and business development strategies and procedures
  • Knowledge of Covance and the overall structure of the organization
  • Thorough knowledge of Covance standard operating procedures

Experience

Minimum Required:

  • Minimum eight (8) years relevant work experience in data management with approximately five (5) years supervisory experience to include data management, clinical operations, knowledge of several therapeutic areas
  • Demonstrated skill for management of staff exceeding 25 employees across multiple locations within a region (Europe, North America, Asia-Pacific, etc)
  • Financial management of gross revenues in excess of $20M per year with strong financial  analytical skills
  • Excellent oral and written communication and presentation skills
  • In depth knowledge of clinical trial process and data management , clinical operations, biometrics, quality management, and systems applications to support operations
  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies
  • Operational experience in other disciplines such as clinical, biometrics, medical writing, pharmacovigilance, safety, quality assurance, regulatory, etc.
  • Demonstrated ability to handle multiple competing priorities across clinical operating units
  • Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
  • Strong managerial and interpersonal skills

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