Senior Clinical Data Programming Lead - Home-Based - Europe (Remote)
Josh Zarembski is partnered with one of the world's largest Clinical Research Organisations at the cutting edge of Biotechnology & Clinical Research. They are expanding their European & US Clinical Data Programming teams.
They are looking for a Programmer with extensive SDTM experience to work in an oversight position, leading studies, and liaising with the US team on multinational studies.
Please find the responsibilities and requirements below:-
- Annotate CRFs in accordance with CDISC-published or sponsor-specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets.
- Build SDTM data set specifications per specified study requirements.
- Program data sets per specification, and validate data sets per the formal, documented CC process
- Build data programming specifications per specified study requirements
- Program clinical data programs per specification
- Validate clinical data programs per the formal, documented CC process.
- Execute programs and generate clinical data outputs to according to study/client requirements.
- Review and quality assure CRF annotations produced by other programmers.
- Participate in testing of clinical data system upgrades and documenting of test scripts when required.
- Lead programming and validation activities across a single project, ensuring that timelines are met and deliverables are of sufficient quality.
- Extensive experience in clinical data programming and delivery
- Demonstrated ability to produce CDISC and sponsor-defined clinical data deliverables
- Experience building SDTM data set specifications
- Experience annotating CRFs in accordance with CDISC or sponsor-specific guidelines
- Successfully handle multiple tasks and timelines.
- Team player with strong verbal and written communication skills
- Advanced knowledge of the clinical data programming development life cycle
- Bachelor’s degree in information systems, science or a related discipline
AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
Email: JZarembski@alsolutions.co.uk OR call (0) 203 778 0909