Key skills
Project ManagementCommunicationTime Management
About this role
Role Overview
- Preparing informed consent documents that disclose information about a clinical trial using health literate language
- Working across multiple therapeutic areas using client tools, systems, guidelines, templates, and processes
- Collaborating with protocol authors to ensure comprehensive understanding of protocol details and the protocol approval timeline
- Writing, editing and reviewing informed consent documents
- Managing informed consent writing projects including the design, planning, and preparation of documentation
- Participating in clinical trial team meetings to ensure timely delivery of the informed consent document(s)
- Resolving document issues relating to informed consent
- Supporting Global Clinical Trial Operations with informed consent process expertise and study specific support
- Participating in the orientation and coaching of junior team members
- Supporting tool development, enhancements, and testing
Requirements
- Life sciences degree
- 3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience
- Scientific Knowledge/Health Literacy
- 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 a summary of a clinical trial design, objectives and activities for a lay audience using guidelines and governmental regulations
- Understanding of appropriate International Council on Harmonization (ICH) and regulatory guidance pertaining to Informed Consent
- 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
- Flexibility in adapting to new tools and technology
- Excellent communication skills (email responses, meeting presentations)
- Effective time management, organizational, and interpersonal skills
- Strong project management skills
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