
Clinical Document Specialist
2 days ago
We help clients modernize their technology infrastructure, adopt cloud and AI solutions, and accelerate innovation.
Our team combines deep industry expertise with agile development practices, enabling scalable and cost-effective digital transformation.
Key Responsibilities:- Author and analyze clinical trial documents.
- Work with key clinical documents: protocol, informed consent form, clinical study report, summary of clinical safety/efficacy, access evidence dossier, statistical analysis plan.
- 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.
What We Offer
We prioritize our employees' growth and well-being. Our work environment is designed to foster collaboration, creativity, and innovation.
If you are a motivated professional looking to make a meaningful impact in the life sciences industry, we encourage you to apply.
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