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Clinical Systems Specialist

Integrated Resources, Inc Cambridge Contractor
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  • Perform activities related User and Site Account Administration and Maintenance within all clinical systems across the clinical platforms for internal and external stakeholders
  • Perform Clinical System Account Creation/management, Issue resolution, process improvement, enhancements, validation and migration improvement
  • Lead/perform clinical information system administration including the definition of best practices and SOPs; creation of SOPs, best practices, training, global work streams related to user account requests, administration and management
  • Work across the portfolio with the Clinical Study Teams to manage Client clinical system reporting;
  • perform as primary liaison for both standard recurrent reports, as well as ad hoc report requests
  • Development and utilization of reports across the clinical systems, identification of efficiencies in ongoing review, trend identification and development of best practices and data flow solutions
  • Ensures effective communication and issue escalation internally and with external vendors
  • Collaborates with clinical development and informatics contributors to define and support clinical system roadmap. Ensures harmonized user and site administrative account management and support across all clinical systems

Here's What You'll Bring to the Table:
  • Bachelors Science Degree in Computer Science, Bioinformatics, Business Information systems or in a relevant technical field or equivalent technical experience
  • 5+ years of Clinical Information System management experience including systems such as EDC, IRT and eTMF experience
  • Experience managing Clinical Information System vendors
  • Prior experience working with multiple Clinical Information Systems simultaneously
  • Knowledge of relational databases (e.g., Medidata Rave®, iMedidata®) and experience with JReview® reporting software is strongly preferred
  • General knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA GCP 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
  • Advanced computer proficiency
  • Demonstrated ability to be flexible and to adapt quickly to change a high degree of initiative, commitment and persistence

Recommended skills

Attention To Detail
Information Systems
Pre Clinical Development
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Job ID: 19-14027


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