Senior Clinical Data Engineer (FSP)

Parexel International Corporation

India, Remote

Responsibilities:

The Senior Clinical Data Engineer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors.
The Senior 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.

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) and responsible for end-to-end non-eCRF/external/third party/vendor data acquisition activities.

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 or develop, update, and maintain non-eCRF or external data transfer specification/agreement document.
Work closely with study team and vendor to set up IXRS UAT to configure Batch-uploader.
Expert in understanding non-eCRF data flow from site till the downstream analysis and good understanding with non-eCRF data handling strategy for biological samples.
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: