Clinical Data Engineer-II

•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/guide
• virtual teams across multiple time zones and cultures to work effectively
• Excellent negotiation skills and ability to influence in order to achieve mutually beneficial results
• Excellent interpersonal, oral and written communication skills using concise phrasing tailored for
• the audience with a diplomatic approach
• Learning ability and knowledge sharing approach; swift understanding of technologies and new
• processes
• A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to
• changing environments
• Customer focus to interact professionally and respectfully within Parexel and all external
• colleagues to build rapport and trust
• Commitment to first time quality, including a methodical and accurate approach to work activities
• Advanced presentation skills
• Time management and prioritization skills in order to meet objectives and timelines
• Highly developed problem-solving skills including capability to make appropriate decisions in
• ambiguous situations, ability to conduct root cause analyses
• Ownership and accountability relative to Key Accountabilities in Job Description
• Good 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 processes
• Demonstrated application of CRS concepts to achieve best practice and promote continuous
• improvement.
• Excellent analytical skills.
• Tenacity to work in an innovative environment.
• Ability to travel as required
• Written and oral fluency in English

Knowledge and Experience:

• Should have working experience as DAS (Data Acquisition Specialist)
• Experience on
• Set 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.