Clinical Data Programming Lead

We have an incredible opportunity for a Clinical Data Programming Lead (SDTM) to join the team.

*The role can be based in Ireland, UK, France, Spain, Poland, Hungary or South Africa - home based or office based.

Summary

Clinical Data Programming Lead (CDPL) is part of the Clinical Data Services (CDS) group involved in clinical data receipt, programming and delivery. The CDPL is responsible for overseeing the set-up and maintenance of clinical data deliverables on multiple clinical studies.

The CDPL participates in activities as related to the specification, validation and quality assurance of study data deliverables and applies competent experience and knowledge in support of the clinical data programmers assigned to a clinical study.

Highlights of Key Responsibilities

• 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.

To succeed you will need

• 4+ years of experience 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 related discipline