Clinical Data Integrator

Clinical Data Integrator This role is outside IR35 Duration - 12 months. Location - Welwyn Hybrid working, with 2 days in the office per week. The pay rate is £50 - £60 Ltd/UMB Summary of Main Responsibilities: Lead and contribute to a use case DataMart, interacting with members of the use-case team to discuss, assess requirements for ADaM dataset creation. Expected to be the SME for ADaMs in their use-case Lead in the development and QC of pooled ADaM datasets Develops and maintains ADaM specifications ensuring consistency with Data Standards where possible, with the ability to deal with the ambiguity of Secondary data usage Working closely with the SDTM curator using the analysis data requirements to guide the SDTM delivery, fostering an exchange of ideas and ensuring internal standards are met Develops software to support pooling of clinical trial data. Analyses business processes, develops, tests, and validates standard software solutions to support these processes. Establishes, promotes, and maintains strong effective working relationships with stakeholders Compliance Is responsible for acting in line with legal, regulatory and company standards and codes of practice Completes all required training modules as a priority Professional and Technical Requirements: University Education in Computer Science, Statistics, Mathematics, or other field (e.g., physics, biology, pharmacology) and at least 5 years' experience in working with ADaMs. Technical Competencies: Relevant technical experience in database management systems and programming Good planning and organizational skills Highly flexible with a systematic and goal-oriented working style Effective teamwork and interpersonal skills (globally, internal, and externally) Effective verbal and written communication skills JOB DESCRIPTION Experience, Skills, Knowledge Must be strong in R programming Excellent knowledge in the development and implementation of complex data manipulation algorithms Good knowledge in the programming of analyses Good knowledge in the principles of software design Excellent knowledge of data modelling and relevant standard data models used to capture clinical study data Good knowledge of the drug development process Good knowledge of GCP and regulatory guidelines Good knowledge of methods used to analyse clinical study data Fluency in written and spoken English At least 5 years' experience in programming using SAS, R or other statistical software packages At least 5 years' experience in programming of analyses of clinical study data Experience as application developer, process analyst and/or application manager. For further details, please contact Rudo Urayayi on (0) or email a copy of your CV to