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Clinical Data Manager

Responsibilities:
  • The Program Clinical Data Manager (PCDM) is accountable for managing all Data Management deliverables within their Program/Therapeutic Area for multiple projects.
  • In particular the PCDM will manage all details associated with the migrations of databases between a legacy system to the current preffered system.
  • This is a key leader position ensuring that development plans are executed efficiently with timely and high quality deliverables with a track record of delivering.
  • Coaches TDMs to provide leadership to project/study teams. Provide active and effective communication to leadership, CTT, program teams and other stakeholder groups.
  • In addition, the PCDM plays a cross-project or functional strategic role, such as representing the function as an SME, during audits or leading large non clinical initiatives.
Requirements:
  • Bachelor's Degree in life science, computer science, pharmacy, nursing, computer programming or equivalent relevant degree. Masters Preferred.
  • 5 years as a PDM on smaller programs including coordination of internal or external data managers
  • 12+ years in Clinical Data Management
  • Understanding of project management concepts in order to aid delivery across a program
  • Excellent verbal and written skills
  • Strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines
  • Excellent understanding of clinical trials methodology, GCP and medical terminology
  • Must be able to anticipate challenges and risks and proactively suggest/implement solutions
  • Ability to work under pressure demonstrating agility through effective and innovative team leadership
  • Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders