Clinical Systems Analyst

Location: Andover, MA
Job Code: 152
# of openings: 14

Description

SUMMARY OF POSITION:

Provides ongoing technical application support for Ora’s clinical information systems.  Assists on the builds, maintenance and administration of Ora’s Clinical Information Systems. 

PRIMARY RESPONSIBILITIES:

  • Assists the evaluation and implementation of various clinical information systems and data management platforms (EDC,CTMS, eTMF, eDiaries, payments systems, electronic regulatory filings, )
  • Helps ensures all clinical information systems are integrated/compatible within Ora and vendors.
  • Helps oversees the development of clinical information standards and support adherence to standards in EDC and other clinical systems
  • Provides ongoing administrative and technical support for all clinical information systems.
  • Provides systems training to end users.
  • Assists in developing and maintaining system, user and training documentation
  • Plays a key role in identifying potential issues and proposes solutions.
  • Ensures that clinical systems continue to meet expectations and make scientific and business sense.  Develop and maintain external software vendor relationships; build vendor collaborations and partnerships.
  • Assists in ensuring clinical systems’ deliverables are aligned and meet clinical operations priority and deadlines.
  • Communicate timelines and assist in coordinating activities within and across functional groups.
  • Assists to ensure computer systems are validated and meet regulatory authority requirements.
  • Provide ongoing support for process improvement
  • Continue to develop clinical study management skills.

REQUIRED SKILLS AND ATTRIBUTES:

  • Knowledge of systems development life cycle, relational databases, database design, development and maintenance.
  • Familiar with clinical information systems such as EDC, CTMS, eTMF.
  • Understanding of clinical drug development process
  • Some project management experience.
  • Strong interpersonal skills.
  • Excellent written and verbal communication skills.
  • Excellent organization and time management skills.

OTHER REQUIREMENTS:

  • Bachelor’s degree in computer science or information systems.
  • 2+ years of hands on experience with clinical systems in a CRO

 

 





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