Clinical Trial Administrator (CTA)
Company: Novo Nordisk
Department: Clinical Development Centre (CDC India)
Location: Bangalore, Karnataka, India
Job Level: 5
Employment Type: Full-Time
Reporting To: Manager – Clinical Operations
About the Company
Novo Nordisk is a global healthcare company headquartered in Denmark and a world leader in diabetes care. With more than 100 years of innovation, the company develops treatments for diabetes, obesity, rare diseases, and other serious chronic conditions. Novo Nordisk India operates from Bangalore and supports multiple global clinical and healthcare initiatives.
Position Overview
The Clinical Trial Administrator (CTA) will provide operational and administrative support to Trial Managers and Clinical Research Associates (CRAs) throughout the lifecycle of clinical trials, including study start-up, execution, and close-out activities.
This role is responsible for ensuring timely clinical project deliverables while maintaining compliance with ICH-GCP guidelines, local regulatory requirements, Novo Nordisk procedures, and study protocols.
The CTA will act as a key operational support resource, coordinating documentation, regulatory submissions, study logistics, investigator meetings, trial supplies, contracts, and study-related administrative activities.
Key Responsibilities
Clinical Trial Operations Support
Support Trial Managers and Clinical Research Associates (CRAs) in day-to-day study activities.
Assist with clinical trial start-up, conduct, maintenance, and closure activities.
Ensure timely completion of assigned project deliverables.
Coordinate operational activities across study stakeholders.
Regulatory & Ethics Committee Submissions
Support preparation and submission of documents to Health Authorities.
Coordinate Ethics Committee (EC) submissions and approvals.
Maintain regulatory documentation and correspondence.
Track submission timelines and approvals.
Study Documentation Management
Customize study documents according to country requirements.
Coordinate document translation activities where required.
Maintain accurate study files and essential documents.
Ensure proper filing of both electronic and physical study records.
Support archival activities at study completion.
Clinical Trial Supply Management
Coordinate trial product supplies and auxiliary supplies.
Support logistics management for study materials.
Maintain appropriate documentation for trial supplies.
Ensure smooth coordination between sites and internal stakeholders.
Contract & Vendor Coordination
Support contract preparation and management activities.
Coordinate communication with vendors and study sites.
Track contract status and required approvals.
Assist with vendor documentation and compliance activities.
Meeting & Event Coordination
Support planning and execution of:
Global Investigator Meetings
Local Investigator Meetings
Study Team Meetings
Departmental Meetings
Coordinate logistics, documentation, and meeting materials.
Study Payment Administration
Support processing and tracking of study-related payments.
Coordinate with finance and operational teams.
Maintain payment records and supporting documentation.
Systems & Database Management
Maintain study information within clinical trial systems.
Ensure data accuracy and completeness.
Support tracking of study milestones and project deliverables.
Generate reports and operational updates as required.
Quality & Compliance
Ensure compliance with:
ICH-GCP Guidelines
Local Regulatory Requirements
Novo Nordisk SOPs
Clinical Trial Protocols
Support inspection and audit readiness activities.
Maintain quality standards throughout trial execution.
Required Qualifications
Education
Bachelor's Degree in:
Life Sciences
Pharmacy (B.Pharm / M.Pharm)
Medical Sciences
Biotechnology
Nursing
Allied Healthcare Sciences
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
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Hajipur | Patna |Kerala :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Lisbon | Oeiras | Portugal |WI :
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Mexico |northeastern :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
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Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Galway |County Dublin :
Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Mississauga | Uxbridge | Renfrew | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
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Bucharest |Buenos Aires :
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Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
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Warsaw |
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