
Senior Clinical Documentation Specialist
1 week ago
About Our Company:
Our company is a global leader in digital engineering and IT services, specializing in the modernization of technology infrastructure, cloud solutions, and AI adoption.
We combine deep industry expertise with agile development practices to deliver scalable and cost-effective digital transformation. With delivery centers across multiple regions, we operate globally and help clients accelerate innovation.
Job Description:
We are seeking an expert Clinical Document Author to join our team. As a key member, you will be responsible for analyzing and authoring clinical trial documents, working with key clinical documents such as protocol, informed consent form, clinical study report, and more.
- Author and analyze clinical trial documents.
- Work with key clinical documents including protocol, informed consent form, clinical study report, summary of clinical safety/efficacy, access evidence dossier, statistical analysis plan, and more.
- Create, validate, and refine prompts for AI-assisted document generation.
- Apply knowledge of clinical trial phases, study design, and drug development.
- Maintain compliance with global regulatory standards (FDA, EMA, ICH-GCP).
- Utilize medical terminologies and ontologies for clarity and consistency.
- Ensure quality control and timely delivery of assigned tasks.
- Collaborate with cross-functional teams to improve document accuracy and prompt effectiveness.
- Provide regular updates and flag risks to the project manager.
Requirements:
To succeed in this role, you should have:
- 1-5 years of experience.
- Any graduation qualification.
Working Mode:
Hybrid
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