Key skills
Communication
About this role
Role Overview
- Prepare study-specific informed consent documents using established templates, information from protocols, content libraries and glossaries (when appropriate), and required risk language
- Work with protocol authors to ensure comprehensive understanding of protocol details and the protocol approval timeline
- Write, edit and review informed consent documents that reflect the principles of health literacy
- Manage informed consent writing projects including the design, planning, and preparation of documentation in support of clinical development
- Participate, when appropriate, in clinical trial team meetings to ensure timely delivery of the informed consent document(s)
- Resolve document issues relating to informed consent
- Support Global Clinical Trial Operations with informed consent process expertise and study specific support
Requirements
- Life sciences degree
- 3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience
- Understanding of protocol structure and knowledge of the relevant information needed to create an informed consent document
- Understanding of clinical trial operations with specific knowledge of informed consent forms
- Ability to prepare, with minimal supervision, a summary of a clinical trial design, objectives and activities for a lay audience using established guidelines and governmental regulations
- Technical expertise in MS Office (Word, Excel, Project) and Adobe Acrobat
- Experience working in document management systems; managing workflows
- Experience with collaborative authoring and review tool
- Understanding of structured content management concepts
- Excellent communication skills (email responses, meeting presentations)
- Complete fluency in reading and writing American English
Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways