Clinical Research Associate

About Client:

Our Client is a global IT services company headquartered in Southborough, Massachusetts, USA. Founded in 1996, with a revenue of $1.8B, with 35,000+ associates worldwide, specializes in digital engineering, and IT services company helping clients modernize their technology infrastructure, adopt cloud and AI solutions, and accelerate innovation. It partners with major firms in banking, healthcare, telecom, and media.

Our Client is known for combining deep industry expertise with agile development practices, enabling scalable and cost-effective digital transformation. The company operates in over 50 locations across more than 25 countries, has delivery centers in Asia, Europe, and North America and is backed by Baring Private Equity Asia.

Job Title: Clinical Document Authoring

Skills: Protocol , Informed Consent Form (ICF) , FDA , EMA , ICH-GCP

Job Locations: Bengaluru , Gurugram

Experience: 1 -5Years

Education Qualification: Any Graduation

Work Mode: Hybrid

Employment Type: Contract

Notice Period: Immediate - 15 Days

Interview Mode: 2 Rounds of Technical Interview

Job Description:

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.

Interested Candidates please share your CV to sushma.n@people-prime.com