Principal Clinical Data Standards Specialist
Job ID: REQ-10027702
Date: Apr 13, 2025
Location: India (Hyderabad Office)
Division: Development
Business Unit: Innovative Medicines
Employment Type: Regular, Full-time
Shift Work: No
Job Summary
The Principal Clinical Data Standards Specialist provides expert support and functional and technical knowledge to ensure scientific integrity and validity across clinical development, early development, and research projects. This role is responsible for driving the implementation of data analytics reports, designing clinical data standards, and supporting the full lifecycle of clinical development from data collection to regulatory submissions.
Key Responsibilities
Implementation of Data Analytics Reports: Drive the creation and implementation of data review reports and dashboards, working closely with users to establish specifications and coordinating with programmers to ensure optimal output.
Business Requirements Translation: Convert business requirements into logical models and direct the development team to translate business logic.
User Requirements & Specifications: Lead the development of user requirements documents, functional specifications, and testing scripts.
Project Management: Develop and execute robust project plans, ensuring timely delivery of projects and data requests while managing resources to meet deadlines.
Training & Change Management: Lead the development of user training programs and manage change activities associated with the implementation of new data review tools.
Data Standards & Automation: Provide expert support for industry-compliant clinical data standards, including EDC tools, data transfer specifications, and automation solutions.
Regulatory Compliance: Ensure the creation of high-quality standards for clinical trials, statistical analysis, and data review to support regulatory submissions and clinical reporting.
Key Performance Indicators
Timely execution of projects and data requests
Positive feedback from project sponsors and key stakeholders
Adherence to Novartis policies and guidelines
Meeting of defined metrics and KPIs
Minimum Requirements
Experience: Strong experience in biostatistics, clinical trials, and data management, with proven expertise in automation, programming, and statistical analysis.
Skills:
Expertise in automation and metadata management
Strong knowledge of biostatistics and clinical trials
Proficient in computer programming and statistical analysis
Languages: Proficiency in English.
Why Novartis?
Novartis is committed to helping people with diseases by driving breakthroughs through innovation and collaboration. The company offers an inclusive and diverse environment that promotes personal and professional growth, providing competitive rewards and benefits.
Commitment to Diversity and Inclusion
Novartis fosters an inclusive work environment where diverse teams represent the communities they serve. Reasonable accommodations are provided to individuals with disabilities.
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Birmingham |Alaska :
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Bridgeport | Bristol | Enfield | Groton | Hartford | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
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Boise |Illinois :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Brinny | Ringaskiddy |County Dublin :
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Dún Laoghaire |Meath :
Dunboyne |Republic of Ireland :
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China | Quarry Bay |Hubei :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
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Croatia |Zagreb :
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North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
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Surabaya |Jakarta :
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Japan | Saitama |Tokyo :
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Remote - Middle East | Remote - Africa | Remote | Remote - Europe | Remote, USA | Remote - South America (Latin Americal) | Switzerland |Bucharest :
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Singapore |South Africa :
Midrand | South Africa |Brazil :
Brazil | Sao paulo |South America :
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Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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Kyiv |Dubai :
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Ho Chi Minh City |