Clinical Trial Administrator (CTA)
Company: Novo Nordisk India Pvt. Ltd.
Department: Clinical Development Centre (CDC India)
Location: Bangalore, Karnataka, India
Job Level: 5
Employment Type: Full-Time
Reporting To: Manager – Clinical Operations
About Novo Nordisk
Novo Nordisk is a global healthcare company headquartered in Denmark and a world leader in diabetes care. With more than 100 years of innovation and a strong commitment to improving patient lives, Novo Nordisk develops and delivers treatments for diabetes, obesity, rare diseases, and other chronic conditions.
The India affiliate, based in Bangalore, supports a wide range of clinical, medical, and business operations while contributing significantly to global healthcare initiatives.
Position Overview
Novo Nordisk is seeking a highly organized and detail-oriented Clinical Trial Administrator (CTA) to support the Clinical Development Centre (CDC India) in the execution of clinical trials.
The CTA will provide operational and administrative support to Trial Managers and Clinical Research Associates (CRAs) throughout the clinical trial lifecycle, including study start-up, execution, and closure activities. The role ensures timely delivery of trial-related activities while maintaining compliance with ICH-GCP guidelines, local regulatory requirements, company SOPs, and study protocols.
Key Responsibilities
Clinical Trial Operations Support
Support Trial Managers and CRAs in day-to-day clinical trial activities.
Assist in study start-up, execution, maintenance, and close-out activities.
Coordinate clinical trial documentation and project deliverables.
Ensure timely completion of assigned study activities.
Regulatory & Ethics Committee Support
Prepare and coordinate submissions to Health Authorities and Ethics Committees.
Assist in regulatory document collection and tracking.
Maintain submission records and correspondence.
Ensure compliance with applicable regulatory requirements.
Study Documentation Management
Customize study documents according to local requirements.
Coordinate translation of study-related documents when required.
Maintain Trial Master File (TMF) documentation.
Ensure proper filing and archiving of electronic and paper-based records.
Support central archival activities upon study completion.
Contract & Vendor Coordination
Support contract preparation and tracking activities.
Coordinate with vendors, investigators, and study sites.
Assist in managing agreements and required study documentation.
Maintain study-related operational records.
Clinical Supply & Logistics Management
Coordinate auxiliary supplies and trial product logistics.
Track shipment and inventory-related activities.
Ensure proper documentation of study material distribution.
Support site supply management requirements.
Investigator Meeting & Event Coordination
Support planning and organization of:
Global Investigator Meetings
Local Investigator Meetings
Study Team Meetings
Departmental Meetings
Coordinate meeting logistics and documentation.
Financial & Payment Support
Support processing of study-related payments.
Maintain payment records and supporting documentation.
Coordinate with finance and operational teams when required.
Systems & Data Management
Maintain study information within clinical trial systems.
Ensure data accuracy and completeness in relevant databases.
Support tracking of study milestones and deliverables.
Generate reports and status updates as required.
Compliance & Quality Management
Ensure adherence to:
ICH-GCP Guidelines
Local Regulatory Requirements
Novo Nordisk SOPs
Clinical Trial Protocols
Maintain inspection and audit readiness.
Support quality assurance activities.
Required Qualifications
Education
Bachelor's Degree in:
Life Sciences
Pharmacy
Medical Sciences
Biotechnology
Nursing
Related Healthcare Discipline
Preferred Qualification
Diploma or Certification in Clinical Research
Experience
Minimum 1 year of experience in:
Clinical Research
Clinical Trial Administration
Clinical Research Coordinator (CRC)
Clinical Trial Assistant (CTA)
Site Management Activities
Clinical Operations Support
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