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This position is in the BUSINESS (Clinical Business Solutions and Innovation group) not IT and is for support of the Clinical System Management team responsible for governance and maintenance of all Clinical Operations systems including the Medidata Clinical Platform (RaveX,CODER, TSDV, CSA, Monitoring,etc.), Oracle Siebel CTMS, Safety Letter Distribution system, Medidata Repository, Analytics platforms, etc.
Candidates must have strong communication, critical thinking and prioritization skills and be able to work independently with oversight.
DEPARTMENT GCRDO = Technology and Information Operations (GTIO)
PREREQUISITES = Bachelor's Degree in a scientific, business or technical field preferred with 2+ years of experience in a clinical operations role with experience in data entry / data reporting and/or experience in system development, support, configuration, analysis and testing
The Business System Analyst (BSA) will be responsible to work cross functionally to drive
quality, consistency and standardization across the GTIO operational and project portfolio.
Candidates must have strong communication, critical thinking and prioritization skills and be able
to work independently with oversight.
Responsibilities include, but are not limited to, the following:
• Supports edits to supporting documents when requested which includes such things as user
guides, job aides or training materials
• Triages requests in collaboration with the Administrator and processes assigned requests
• Triage problem/issue/questions received from business functions
• Perform data analysis and run quality control checks to ensure compliance to data capture
procedures and business expectations; interface with functional areas on quality issues
through to resolution.
• Participate in requirements gathering and testing as new sources
• Creation review and implementation of change request (add things around conduct impact
analysis of change for business process, technical and training related documents)
• Support User Acceptance testing
o Develop testing strategy, test case development, and associated test documentation
o Review and quality check executed UAT scripts, reviewing defects and facilitating
prompt resolution to keep UAT timelines on track
o Provide test management oversight including scheduling / resource identification
o Update scripts based on defects and change requests from the onsite leads
Skills / Knowledge Required
• 2+ years of Clinical Operations Pharmaceutical/Biotech/Healthcare experience
• Bachelor's Degree in a scientific, business or technical field
• Possesses high level initiative and ability to multi-task and prioritize
• Excellent communication skills (both oral and written), with the ability to communicate across
multiple functions and levels
• Ability to diagnose and resolve issues proactively with minimal supervision in a fast-paced
• Attention to detail
• Familiarity with Microsoft office programs including SharePoint and proficiency in Microsoft
• Ability to analyze and evaluate information and determine action plan based
on analysis of the underlying question / problem
• Ability to recognize and determine similarities in questions / problems raised
and identify potential fixes for the problem, including both potential technical
solutions as well as business process changes
vAbility to identify inconsistencies and ambig
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