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Clinical Data Engineer II

Parexel International Corporation

SHANGHAI, Shanghai, China

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

  • 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.
  • 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.

Job posted: 2023-03-30

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