Clinical Data Engineer I

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Clinical Data Engineer I works with close supervision to support various activities related to electronic data, and/or the application of computer and communication technologies. 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. 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:
 

Manage Projects & Technology:

• 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.

• 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 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.
   

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.
 

Skills:

• Strong ability to collaborate with global teams and work independently.

• Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach.

• Demonstrate ability to learn new systems and 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.

• 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.

• Written and oral fluency in English.
   

Knowledge and Experience:

• Basic experience 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 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.