Senior Clinical Data Management Director

2 semanas atrás

Lisboa, Lisboa, Portugal IQVIA Tempo inteiro

Job Overview

This role is responsible for providing line management to an assigned data management team. The Director will be accountable for delivering strategic solutions and process improvements for clients.

Key Responsibilities

  1. Provide leadership of clinical data management activities across one or more programs, enabling planning, coordination, and timely delivery of complete, high-quality, and reliable clinical trial data for regulatory approval and market acceptance.
  2. Lead a functional department of data management staff, with team sizes ranging from 15 to 40, and may be a first-line or second-line management position.
  3. Define and prioritize resource requirements and manage resource assignments across projects.
  4. Monitor and manage utilization and productivity of the functional department.
  5. Assess and document competency of staff to satisfy position responsibilities. Regularly set goals, evaluate, and document performance, and assist management in developing department strategy and team building.
  6. Define and implement department objectives consistently with broader organization objectives.
  7. Provide expert review and guidance for data management deliverables, database setup, validation, and programming, data management plans, and database deliverables to internal and external customers.
  8. Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency.
  9. Participate in defining strategies for new processes and technology.
  10. Define and implement training and professional development strategies for the functional department.
  11. Manage relationships with customers at both the project team level and with functional peers.
  12. Provide operational input into proposals and scope of work. Participate in proposal defenses. Provide input to costing algorithms, particularly at the customer level.
  13. Attend customer meetings and lead discussions of project requirements and strategic planning.
  14. Establish a highly motivated and enthusiastic global data management team, ensuring open communication and high-quality work.
  15. Serve as a senior representative/contact point of escalation with Sponsor. Participate in bid defense, provide input on scope and budget development.
  16. Contribute to the development and application of smart systems and optimal approaches to support the collection, integration, monitoring, review, and reporting of data to simplify and enhance user experience or lead to efficiencies in execution.
  17. Participate in continuous improvement activities, defining and implementing changes required to create an industry-leading clinical data capability, including electronic data capture, external data integration, ad-hoc analysis, and end-to-end data standards.

Qualifications

  1. Graduate degree in science or bachelor's in pharmacy or equivalent qualification.
  2. Experience: 7+ years of relevant work experience, including substantial people management experience, or an equivalent combination of education, training, and experience.
  3. Thorough knowledge of the data management process and experience in specialized data management skills.
  4. Knowledge of operating procedures and work instructions and the ability to apply them in practice.
  5. Understanding of the clinical drug development process.
  6. Previous experience and proven competence in managing delivery of projects through the full data management study life cycle.
  7. Knowledge of computer applications (MS Office, clinical applications, internet usage).
  8. Excellent organizational, interpersonal, communication, and data management skills, with the demonstrated ability to delegate appropriately.
  9. Ability to exercise excellent attention to detail.
  10. Manage customer relationships.
  11. Leadership and communication capabilities, with a proven ability to engage, manage, develop, and inspire a geographically diverse team.

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at IQVIA website.

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