Senior Clinical Data Engineer
Parexel International Corporation
Hyderabad, Telangana, India
The Principal Clinical Data Engineer will be recognized as a subject matter expert, providing technical
support and expert advice to internal and external sponsors. In addition, the Principal Data Engineer will fill
the lead role on projects; liaise with sponsors, Data Management Leads and other functional areas as
required. Furthermore, the Principal Data Engineer will have an account oversight role within the function.
General areas of responsibility also include: Aggregating applicable data from all sources and devices,
managing external data, programming offline listings, trend analysis, understanding clinical data, data
transfers. Furthermore, responsibilities will include developing standards and libraries (e.g. macros,
templates or multi use-programs) to drive efficiencies within the group. All tasks should be performed in
accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other
international regulatory requirements.
Manage Projects and Technology Lead and implement the setup of Data Receipt Agreements with vendors by working with cross functional teams. Programming and setup of Import procedures to allow the ingestion of data either using SAS or alternative technology (e.g. “Workbench”)Programming of reconciliation checks to ensure appropriate transfer of data.Programming of offline listings and custom reports to allow better insights to all external data.Aggrege data across all sources.Handling Missing Values, reading raw data files, creating data structures, handling programming errors, accessing, and managing data, appending and concatenating SAS datasets.Review of data using created outputs with aim of providing insights to study teams and clients.Accountable for first time quality on all deliverables.Provide input into and negotiate electronic data timelines. Ensure that timelines are adhered to by: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 and budgetManage the deployment of the DM technology used for creation of offline listings (e.g. Workbench, SAS or R).Act as SME or technology owner on DM offline listing technology.
Documentation Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams.Maintain technical documentation that is applicable to the Clinical Database.Support Initiatives Participate in the creation of standards, either through tools, libraries or processes, as required for GDO to ensure efficient, effective and optimal processes.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.Lead or drive global initiatives (related to processes or new tools/technologies)Act as a mentor and/or SME Provide, create and implement relevant training to staff. Provide mentorship to staff and project teams as appropriate. Assist project teams in the resolution of problems encountered in the conduct of their daily work.Assist in providing technical solutions to internal or external client enquires.Maintain and expand local and international regulatory knowledge within the clinical industry.
QualificationsExcellent ability to lead and collaborate with global teams and work independently. Motivate/guidevirtual 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 forthe audience with a diplomatic approach. Learning ability and knowledge sharing approach; swift understanding of technologies and newprocesses. 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 externalcolleagues 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 inambiguous 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 continuousimprovement. Excellent analytical skills. Tenacity to work in an innovative environment. Ability to travel as required Written and oral fluency in English