Job Title: Associate – Clinical Trial Submission Management
Job ID: R-206611
Location: India – Hyderabad
Work Location Type: On Site
Date Posted: April 7, 2025
Category: Safety
About the Role
In this vital role, the Associate – Clinical Trial Submission Management will help ensure the technical compliance of Clinical Trial submissions by facilitating the seamless and compliant flow of information between various stakeholders, including functional teams, local offices, partners, and regulatory authorities. The role is key to supporting Clinical Trial Application approvals in the EU through CTIS (Clinical Trial Information System).
Key Responsibilities
Assigned to one or more Amgen products to support Clinical Trial Application (CTA) approvals in the EU throughout the entire study lifecycle.
Ensure compliance with EU Clinical Trials Regulation (EU CTR) through expertise in CTIS.
Collaborate cross-functionally to support regulatory deliverables and submission content plans.
Perform Quality Control (QC) of data and documents prior to CTIS uploads.
Coordinate the Request for Information (RFI) process including document triage, technical prep, submission via CTIS, and archiving.
Manage Clinical Trial Notifications and data entry in CTIS and internal systems.
Assist in process development and continuous improvement related to CTIS operations.
Troubleshoot and resolve issues that impact submission process or timelines.
Basic Qualifications
Bachelor’s degree with 0–3 years of directly related experience
OR
Diploma with 4–7 years of directly related experience
Preferred Qualifications
Practical experience with Veeva Vault
Familiarity with global regulatory standards and processes
Quick learner of software, regulations, and tools
Proactive, innovative, organized, and a strong team player
What You Can Expect from Amgen
A collaborative and supportive environment focused on professional and personal growth
Competitive Total Rewards Plans aligned with local industry standards
Opportunities to contribute to life-changing medical innovations
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Ranchi |Sikkim :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Frank Scottile Blvd |Missouri :
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Saarbrucken |Switzerland :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
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Shanghai Shi |Hubei :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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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 :
Mississauga | North York | Australia | Uxbridge | Renfrew | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |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 :
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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
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Prague |Chile :
Santiago |Bosnia and Herzegovina :
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