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Clinical Systems Administrator

5 months ago

Dubai, United Arab Emirates Dice Full time


Job Description:

  • Our client is seeking a Clinical Systems Administrator to lead the User and Site Account Administration within all clinical systems across the clinical platform.
  • This position will initiate best practices and processes related to user and site account management. This role will report to the Sr. Manager, Clinical Data Systems.

Here's What You'll Do:

  • Perform activities related User and Site Account Administration within all clinical systems (i.e; EDC, IRT) across the clinical platforms for internal and external stakeholders.
  • Perform Clinical System Account Creation/management and Issue resolution.
  • Work across the portfolio with the Clinical Study Teams to manage clinical system reporting; perform as primary liaison for both standard recurrent reports, as well as ad hoc report requests.
  • Ensures effective communication and issue escalation internally and with external vendors.
  • Participate in User Acceptance Testing (UAT)across the clinical platforms.

Skills, Education and Experience:

  • Bachelor's Science Degree in Computer Science, Bioinformatics, Business Information systems or in a relevant technical field or equivalent technical experience
  • 2-5+ years of Clinical Information System management experience including systems such as EDC, IRT and eTMF experience
  • Experience managing Clinical Information System vendors such as iMedidata, Endpoint Clinical, and Suvoda
  • Prior experience working with multiple Clinical Information Systems simultaneously.
  • General knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA Google Cloud Platform guidelines
  • Detailed knowledge of FDA CFR Part 11 regulations
  • Good organization and project management skills with a demonstrated ability to work independently, take initiative, complete tasks to deadlines.
  • Requires strong attention to detail, document organization skills and scheduling.
  • Excellent communication skills and strong customer focus with ability to interact in a cross functional organization and team environment.
  • Ability to communicate effectively with external vendors, including issue escalation, and responding to inquiries and concerns.
  • Must be able to work in a fast-paced environment with demonstrated ability to prioritize multiple competing tasks.
  • Some holiday and weekend coverage may be required.
  • Advanced computer proficiency
  • Demonstrated ability to be flexible and to adapt quickly to change a high degree of initiative, commitment, and persistence.