Clinical Data Management Specialist
Company: Alvotech
Location: Bangalore / Remote (India)
Job Type: Full-Time
Experience: 7+ Years
Qualification: Bachelor’s Degree (Life Sciences or related)
Job Overview
This role focuses on end-to-end clinical data management, ensuring accuracy, completeness, and reliability of clinical trial data for regulatory submission and analysis. You will handle data management activities from study setup to database lock while working closely with cross-functional teams.
Key Responsibilities
Study Setup & Data Systems
Design eCRFs and configure EDC systems
Develop validation checks and perform UAT
Manage integration of EDC, IWRS, and other systems
Data Management & Quality
Review clinical data and manage queries
Ensure data accuracy, completeness, and consistency
Oversee CRF data entry and query resolution
Data Handling & Reconciliation
Manage data transfers from labs, safety systems, IRT, ePRO
Perform reconciliation across multiple data sources
Maintain data management documentation and working files
Study Execution & Coordination
Manage end-to-end study activities and timelines
Coordinate with project teams and vendors
Monitor KPIs and ensure adherence to timelines
Regulatory & Compliance
Ensure compliance with GCP, 21 CFR Part 11, and other guidelines
Support audits and inspections
Maintain eTMF documentation and perform QC checks
Standards & Documentation
Support SDTM implementation and CDISC standards
Review study documents like protocol and monitoring plan
Required Skills
Clinical data management experience
Knowledge of EDC systems (Medidata Rave, Veeva EDC, etc.)
Understanding of GCP and regulatory requirements
CDISC standards (CDASH, SDTM)
Strong analytical and problem-solving skills
Communication and stakeholder coordination
Uttar Pradesh :
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Siliguri |Illinois :
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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 :
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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Brinny | Ringaskiddy |Carlow :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Osaka | Tokyo |Shanghai Sai :
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Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 :
Renfrew | Mississauga | Richmond Hill | Australia | North York | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Seoul |Kazakhstan :
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Bangkok |Israel :
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