Senior Clinical Data Engineer

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).

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 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.
* 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

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

Job Industries

• Other