Principal Clinical Data Engineer (FSP)

Job Purpose:

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.

Key Accountabilities:

Accountability & Supporting Activities

Manage Projects & 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.

DocumentationMaintain 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.

Support InitiativesParticipate in the creation of standards, either through tools (e.g. SAS Macros), 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 efficienciesLead or drive global initiatives (related to processes or new tools/technologies)

Act as a mentor and/or SMEProvide, 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.

Support Business DevelopmentPrepare for and participate in Bid defense meetings.Independently support with ideas around technology and data engineering setup to help drive winning new business.

Account LeadershipPoint of contact for clients and within Parexel for electronic data specific Matters

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 effectivelyExcellent negotiation skills and ability to influence in order to achieve mutually beneficial resultsExcellent interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approachLearning ability and knowledge sharing approach; swift understanding of technologies and new processesA flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environmentsCustomer focus to interact professionally and respectfully within Parexel and all external colleagues 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 in ambiguous 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 continuous improvement.Excellent analytical skills.Tenacity to work in an innovative environment.Ability to travel as requiredWritten and oral fluency in English

Knowledge and Experience:Proficiency in at least one of the following (e.g. SQL, SAS, R).Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICHGCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.Strong experience working with at least two systems used to aggregate data within the Clinical Trial process (e.g. SAS, Workbench, Elluminate.Strong experience in clinical research industry or similar field is requiredTeam and Project leadership experience required.

Education:Bachelor’s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.

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