•The Clinical Data Engineer II will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors.
•The Clinical Data Engineer II will fill the lead role on projects; liaise with sponsors, Data Management Leads and other functional areas as required.
•Accountable for first time quality on all deliverables.
•Actively assume activities on a project as required.
•Monitor project resourcing and identify changes in scope.
•Assist project teams in the resolution of problems encountered in the conduct of their daily work to ensure first- time quality.
•Provide technical support and advice to the internal team.
•Coordinate and lead a programming team to successful completion of a study within given timelines
•Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance.
•Lead or drive global initiatives – Develop, improve and implement project specific tools, including, but not
•limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies
Skills:
Excellent ability to lead and collaborate with global teams and work independently. Motivate/guidevirtual teams across multiple time zones and cultures to work effectivelyExcellent negotiation skills and ability to influence in order to achieve mutually beneficial resultsExcellent interpersonal, oral and written communication skills using concise phrasing tailored forthe audience with a diplomatic approachLearning ability and knowledge sharing approach; swift understanding of technologies and newprocessesA flexible attitude with respect to work assignments and new learning; ability to adjust rapidly tochanging environmentsCustomer focus to interact professionally and respectfully within Parexel and all externalcolleagues to build rapport and trustCommitment to first time quality, including a methodical and accurate approach to work activitiesAdvanced presentation skillsTime management and prioritization skills in order to meet objectives and timelinesHighly developed problem-solving skills including capability to make appropriate decisions inambiguous situations, ability to conduct root cause analysesOwnership and accountability relative to Key Accountabilities in Job DescriptionGood business awareness/business development skills (including financial awareness).Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.Demonstrate commitment to refine quality processesDemonstrated application of CRS concepts to achieve best practice and promote continuousimprovement.Excellent analytical skills.Tenacity to work in an innovative environment.Ability to travel as requiredWritten and oral fluency in English
Knowledge and Experience:
Should have working experience as DAS (Data Acquisition Specialist)Experience onSet up of conformance checks for Test/Prod data when the study is on ‘Go live’.Draft FFS/Blueprint for non-CRF data collected for a study.Work closely with study team and vendor to set up IXRS UAT to configure Batch-uploader.Programming of Reconciliation to ensure the non-CRF data is without any discrepancies.Programming of offline listings to ensure EDC data and Vendor data doesn’t have any mismatches, along with CRF listings.Programming of QASH checks to compare inventory file received from vendor against RAVE data to find any discrepancies.
Education:
Bachelor’s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.
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