
Senior Clinical Document Specialist
2 days ago
About Our Client:
We are a global IT services company with headquarters in the United States. Founded in 1996, we specialize in digital engineering and IT services. We help clients modernize their technology infrastructure, adopt cloud and AI solutions, and accelerate innovation.
Our team operates in over 50 locations across more than 25 countries, has delivery centers in Asia, Europe, and North America.
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.
Required Skills and Qualifications:
1-5 years of experience in clinical research or a related field.
Any graduation degree is required.
Benefits:
Hybrid work mode available.
Contract employment type.
Immediate - 15 days notice period.
Interview mode: 2 rounds of technical interview.
Job Locations:
Bengaluru, Gurugram.
Interested Candidates please share your CV to sushma.n@people-prime.com
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