Senior Clinical Data Engineer

Senior Clinical Data Engineer provides expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various activities related to electronic data, and/or the applications/systems within eClinical technologies. In addition, the Senior Clinical Data Engineer will serve as a Lead role on projects, and liaise with sponsors, Data Management Lead and other functional areas as required. General areas of responsibility also include: Aggregating applicable data from all sources and devices, managing external data, programming offline listings, trend analysis, data review, data transfers. Furthermore, responsibilities will include developing standards and libraries (e.g. SAS macros, templates or Programs) to drive efficiencies within the group. All tasks should be performed in accordance with corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.

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:
• 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 budget.
• Manage the deployment of DM technology used for creation of offline listings (e.g. Workbench, R).
  

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.
  
  

Act As a Mentor And/or SME

• Provide 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

• Support Bid defense meetings.
  
  

Skills

• Strong ability to lead and collaborate with global teams and work independently. Motivate/guide virtual teams across multiple time zones and cultures to work effectively.
• Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach.
• Swift understanding of new systems and processes. function in an evolving technical environment.
• 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.
• Proficient presentation skills.
• Time management and prioritization skills in order to meet objectives and timelines.
• Proven 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

• Demonstrated expertise in R programming, with substantial hands-on experience in professional settings.
• 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.
• 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.
  
  

Education

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