The Principal standards Developer is a member of Clinical Data Standards team, primarily responsible for leading the development, management and maintenance of Clinical Data Standards (raw data standards with collection and cleaning components) for assigned clinical projects, with quality and timeliness. Acts as subject matter expert and can be responsible for leading cross function projects and/or initiatives within Clinical data standards and may manage external partner relationships or initiatives. May provide training or coaching to junior colleagues.

Typical Accountabilities

• Leads clinical data standards projects
• Technical subject matter expert in specialised area of clinical standards for raw data standards with data collection and cleaning components
• Manages activities of our CRO partners and external partners
• Leads quality of own deliverables and oversees quality of other developers’ standards deliverables
• Drives standards development and implementation within the business
• Identifies opportunities to improve process & methodology and provides practical solutions for problems
• Contributes or leads cross-functional or process improvement initiatives
• Drives the development of best practices to improve quality, efficiency and/or effectiveness within function
• Provides input to standards strategy and leads the implementation of strategy components to meet the evolving internal and external landscape
• Leads standards governance and best practice
• Can contribute to external industry standards and governance groups
• Collaborates and contributes within internal clinical standards governance groups

Education, Qualifications, Skills, Experience

• BSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science or equivalent experience.
• Expertise in specialised standards development skills (eg, raw data standards with data collection and cleaning components)
• Ability to apply standards expertise to problem
• Excellent communication skills in both written and spoken English 
• Ability to mentor, train and lead teams

• A clear demonstration of behaviours of truth seeking rather than success seeking
• Agile responsiveness to industry and business needs
• Embracing of peer review

Essential

• Strong project management skills    
• Excellent communication skills in both written and spoken English 
• Thorough knowledge of the clinical development process
• Experience on clinical study EDC from data management and/or site user perspective

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.