The role can be home based in UK or South Africa.
The Principal Clinical Data Engineer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. In addition, the Principal Data Engineer will fill the lead role on projects; liaise with sponsors, Data Management Leads and other functional areas as required. Furthermore, the Principal Data Engineer will have an account oversight role within the function. General areas of responsibility also include: Aggregating applicable data from all sources and devices, managing external data, programming offline listings, trend analysis, understanding clinical data, data transfers. Furthermore, responsibilities will include developing standards and libraries (e.g. macros, templates or multi use-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.
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).
- Act as SME or technology owner on DM offline listing technology.
- 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.
- 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 and 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.
Ideal candidate will possess:
- SQL experience.
- Experience in ETL Programming environment (e.g. Oracle Workbench, Elluminate, SAS, Python, etc.).
- 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 in clinical research industry is desirable.
- Written and oral fluency in English.
- Bachelor’s degree in a relevant science discipline.
- 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.
- Commitment to first time quality, including a methodical and accurate approach to work activities
- Proficient presentation skills.
- 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.