
Senior Clinical Documentation Specialist
1 day ago
About Us:
We are a leading provider of digital engineering and IT services.
Our expertise combines deep industry knowledge with agile development practices, enabling scalable and cost-effective solutions for our clients.
Job Title: Clinical Document Author
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 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.
Required Skills and Qualifications:
- Protocol , Informed Consent Form (ICF) , FDA , EMA , ICH-GCP
Benefits:
- Experience: 1 -5 Years
- Education Qualification: Any Graduation
- Work Mode: Hybrid
- Employment Type: Contract
- Notice Period: Immediate - 15 Days
- Interview Mode: 2 Rounds of Technical Interview
Others:
We encourage interested candidates to submit their CVs for consideration.
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