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Job Location: Bhagya Nagar
- The Principal Clinical Data Engineer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors.
- The Principal Data Engineer 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
- 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
- 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
- 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.
- Bachelor’s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.