
Clinical Document Specialist
4 days ago
About Us:
We are a global organization specializing in digital engineering and IT services. With a presence in over 50 locations across more than 25 countries, we help clients modernize their technology infrastructure, adopt cloud and AI solutions, and accelerate innovation.
Clinical Document Authoring Role:
This role involves creating and analyzing clinical trial documents. The ideal candidate will have expertise in producing key clinical documents, including protocols, informed consent forms, and clinical study reports. They will also apply knowledge of clinical trial phases, study design, and drug development to ensure compliance with global regulatory standards.
Main 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
- 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:
- 1-5 years of experience in clinical research or a related field
- Any graduation degree
- Strong understanding of clinical trial phases, study design, and drug development
- Excellent communication and analytical skills
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