AL Solutions have partnered with mid-sized CRO, they are looking for a talented Clinical Programmer to join there European team. The position is a fully remote working from anywhere in UK, Germany and Netherlands.
- Design, build, test and release clinical databases
- Improve & maintain all clinical programming documentations
- Develop & review Data Validation Plan
- Program electronic edit checks & data listings required for data review & validation process
- Review electronic Case Report Form (eCRF) Completion guidelines
- Develop SAS programs for metric reporting, data review listings, data import and data export set-up
- Lead application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities and data warehousing, i.e. CDASH and SDTM modules
- Review and adhere to the requirements of study specific data management documents & plans
- Lead and coordinates clinical programming activities for assigned studies
- Actively contributes in study team, company meetings & sponsor meetings
- Collaborate with peers and study
- Provide leadership, guidance and support to other department members.
- Understand validation principles
- Lead development activities and standardizing clinical programming procedures
- Assist in study audits
- Research and propose initiatives for improving efficiency
- Background in clinical trials either in a CRO, Pharma and Biotech.
- Good knowledge of ICH-GCP(R2), GDPR/HIPPA & applicable (local) regulatory requirements
- Good understanding of programming clinical data management
- Experienced in technical data management practices
- Solid hands-on experiences of CDISC standards (i.e. CDASH and SDTM models)
- Strong technical, analytical and problem-solving skills
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.