Senior Clinical Trial Transparency Associate
1 miesiąc temu
The role can be based in Eastern Europe
Responsibilities:
Supporting Clinical Trial Transparency deliverables, in cooperation with senior CTT Team members
- Create and support numerous CTT deliverables including, but not limited to clinical trial disclosure to registries, redactions, results summaries, etc. in liaison with cross functional teams under limited supervision of senior CTT team members
- Assess document requirements, gauge document complexity, and identify information gaps or issues.
- Produce high quality, accurate, and fit-for-purpose documents
- Takes initiative and creativity in solving routine problems that affect multiple documents; ensures consistency between related documents
- Provide project teams with expertise and strategic guidance on analysis and presentation of CTT data and documents
- Takes initiative and creativity in solving routine problems that affect multiple documents; ensures consistency between related documents
- Systematically review and/or perform quality control checks of CTT deliverables prepared by junior CTT team members against pre specified check lists and requirements
Working knowledge of transparency related FDA, EMA and other global regulations, ICH guidelines, Good Clinical Practices, the drug development process, MedDRA and regulatory requirements.
- Ability to write and review CTT specific documents under supervision.
- 3-5 years of experience in Clinical Trial Transparency area
Experience and technical skills within Clinical Trial Transparency, as a part of a pharmaceutical company or CRO would be an advantage.
- Process and project management skills; ability to multitask while driving towards critical deadlines on all projects.
- Good interpersonal skills and the ability to work within a team in collaborative and supportive role
- Fluent in English (oral and written)
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