Senior Clinical Data Engineer - multiple EU/UK locations

The role can be flexibly based in multiple EU/UK locations.

Job Purpose:

The 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 Data Engineer Programmer 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 to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international

regulatory requirements.

Key Accountabilities:Manage electronic Data & 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. 

• 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).  

Support Projects    

• Assist in providing technical solutions to internal or external/client enquires. 

• Ensure adherence to service levels agreements with regard to the turnaround time from the point when specifications are finalized.

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.

Account Leadership and Business Development

• Point of contact for clients and within Parexel for electronic data specific matters.

• Support Bid defense meetings.

Ideal candidate will possess:

• Bachelor’s degree in a relevant discipline.

• Fluent English.

• Proficiency in at least one of the following: 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.

• 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.

• 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.