Clinical Data Integrator

2 weeks ago


Welwyn, United Kingdom Clearline Recruitmentment Ltd Full time

**Job Title**:Clinical Data Integrator
**Location**:Welwyn (Hybrid)
**Salary**:£50 - £60 Ltd **or**£37.29 - £44.75 PAYE (excluding holiday pay)
**Full Time**:Hybrid working with 2 days in the office per week
**12-month contract outside IR25**

**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 company 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
- Is responsible for acting in line with legal, regulatory and company standards and codes of practice (e.g. company Code of Conduct, applicable company directives, guidelines and SOPs)
- Completes all required training modules as a priority

**Requirements**:

- University Education in Computer Science, Statistics, Mathematics, or other fields (e.g., physics, biology, pharmacology) and at least 5 years experience in working with ADaMs
- 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, internally, and externally)
- Effective verbal and written communication skills
- 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 modeling 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

**For more information, please contact Chloe McCausland at Clearline Recruitment.


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