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Clinical Research Associate - Delhi

Novo Nordisk
Novo Nordisk
2-4 years
Not Disclosed
Delhi, India
10 March 14, 2026
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Position Summary
The Clinical Research Associate (CRA) is responsible for overseeing and managing clinical trial sites to ensure adherence to study protocols, regulatory requirements, and patient safety standards. The role focuses on executing high-quality clinical trials through effective site monitoring, risk-based quality management, and collaboration with internal and external stakeholders.

Key Responsibilities

Site Management & Monitoring

Serve as the primary liaison between assigned clinical sites and the study team.

Conduct on-site and remote monitoring visits in accordance with monitoring plans, protocols, ICH-GCP guidelines, internal SOPs, and regulatory requirements.

Ensure patient safety, protocol compliance, and data integrity during clinical trial execution.

Manage and resolve clinical data queries and monitor adverse event reporting.

Track site performance including recruitment, retention, and data delivery timelines.

Oversee investigational medicinal product (IMP) accountability, study supplies, and essential documents.

Provide training and operational support to site staff on protocols, systems, and compliance requirements.

Maintain accurate and updated trial documentation including Investigator Trial Master File (TMF).

Quality Oversight

Implement risk-based quality management strategies to identify and mitigate study risks.

Support timely data cleaning and data flow activities.

Maintain audit and inspection readiness throughout the study lifecycle.

Ensure clinical trial activities comply with ICH-GCP, regulatory requirements, and internal procedures.

Stakeholder Collaboration

Build strong relationships with investigators, site coordinators, and clinical teams.

Participate in investigator meetings, project meetings, and CRA training programs.

Share site insights and operational feedback to support protocol improvements and patient engagement initiatives.

Collaborate with cross-functional teams including Data Management, Study Start-Up, Vendor Management, and Clinical Operations.

Professional Experience Requirements

Minimum 2–4 years of experience working as a Clinical Research Associate.

Experience working in multinational clinical trials (Phase II–III).

Experience managing studies from site initiation through site closure.

Knowledge of clinical trial regulations, monitoring processes, and documentation standards.

Strong understanding of clinical trial systems including EDC, CTMS, and eTMF.

Apply Details

Apply through the official careers portal of
Novo Nordisk before 20 March 2026.