Principal Clinical Data Engineer

Company: Parexel International Corporation
Location: King Of Prussia
Posted on: May 19, 2025

Job Description:

Key Accountabilities: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:o Actively assume activities on a project as required.
  o Monitor project resourcing and identify changes in scope.
  o Assist project teams in the resolution of problems encountered in the conduct of their daily work to ensure first- time quality.
  o 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 budget.
  • Manage 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.Support Initiatives
    • Participate 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 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.Support Business Development
        • Prepare for and participate in Bid defense meetings.
        • Independently support with ideas around technology and data engineering setup to help drive winning new business.Account Leadership Point of contact for clients and within Parexel for electronic data specific mattersSkills:
          • 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:
            • 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 required.
            • Team and Project leadership experience required.Education:
              Bachelor's degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.Required
              Preferred

              Job Industries

              • Other

Keywords: Parexel International Corporation, Towson , Principal Clinical Data Engineer, Engineering , King Of Prussia, Maryland