The Documentation Specialist will assist with clinical document -related editing and proof reading activities supporting Clinical Expert Teams/Study Management teams:
- Supports the development of high-quality clinical documents e.g. study protocols, amendment documents, informed consent forms, subject information leaflets etc.
- Is accountable for Planning, creation and co-ordination of timelines for the production and review of clinical protocol-related documents ensuring alignment with overall project timelines.
- Co-ordinates the clinical protocol-related documents draft and review process including generation of draft document from content provided by contributing authors; collection, adjudication, and incorporation of comments from team, cross-functional and functional reviewers; and resolution of issues/errors/inconsistencies with team members.
- Edits and/or proof-reads pRED clinical protocols and related documents. Is accountable to ensure consistency, accuracy and compliance with local and global guidelines.
- Supports selection and management of appropriate templates within documentation system.
- Is accountable to ensure documents are published and approved by the accountable signatory.
- Provides support to technical review meetings such as DRC (minutes, etc)
- Participates as needed as a member or ad-hoc participant of key functional/cross-functional teams (i.e., project team, clinical team, study management team) to ensure appropriate documentation guidance and support.
- Collaborates with Regulatory Clinical Documentation Group to ensure consistency of submission documentation.