Senior Lead Clinical Data Science Programmer
Company: ICON plc
Location: Chennai / Bengaluru / Trivandrum, India
Department: Clinical Data Science & Clinical Data Management
Job Type: Full-Time
Work Mode: Office or Home (Hybrid/Remote)
JOB OVERVIEW
The Senior Lead Clinical Data Science Programmer is responsible for leading external clinical data management and programming activities across global clinical trials. The role involves developing and maintaining Data Transfer Specifications (DTS), managing external clinical data integrations, ensuring compliance with CDISC standards, supporting data reconciliation, collaborating with cross-functional teams and vendors, and driving data harmonization to ensure high-quality, compliant clinical trial data for downstream analytics and regulatory submissions.
KEY RESPONSIBILITIES
Clinical Data Programming
Lead the development and maintenance of Data Transfer Specifications (DTS).
Define external data structures for clinical studies.
Develop standardized data templates.
Support clinical data programming activities.
Ensure consistency across multiple external data sources.
External Data Management
Coordinate external data deliveries from vendors.
Track DTS status and study deliverables.
Manage external data timelines.
Resolve data structure and format issues.
Ensure complete and accurate data transfers.
Data Integration & Reconciliation
Support external data reconciliation activities.
Investigate and resolve data discrepancies.
Review external data structures for consistency.
Process DTS change requests.
Maintain data quality throughout the study lifecycle.
Clinical Study Support
Participate as an extended member of Clinical Study Teams.
Support eCRF and EDC build activities.
Collaborate with Clinical Data Management teams.
Coordinate Biomarker, Imaging, and eCOA data requirements.
Support study-specific external data requirements.
Standards & Regulatory Compliance
Ensure compliance with CDISC standards.
Apply regulatory requirements to external data processes.
Maintain standardized clinical data templates.
Support data harmonization initiatives.
Ensure adherence to company SOPs and industry regulations.
Vendor & Stakeholder Management
Collaborate with external data providers and research partners.
Respond to vendor and stakeholder queries.
Provide oversight of external data vendors.
Facilitate communication across functional teams.
Escalate critical data issues when required.
Process Improvement & Leadership
Drive continuous improvement initiatives.
Enhance DTS templates and documentation.
Develop standardized external data processes.
Train study teams on DTS and external data workflows.
Mentor team members on clinical data standards and best practices.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree or Master's Degree in:
Life Sciences
Pharmacy
Biotechnology
Biostatistics
Computer Science
Statistics
Biomedical Sciences
Clinical Research
Or a related discipline
EXPERIENCE REQUIREMENTS
Required
Experience in:
Clinical Data Management
Clinical Data Programming
External Data Management
Data Transfer Specifications (DTS)
Clinical Research
Clinical Database Management
Preferred
Experience with CDISC standards.
Knowledge of EDC and eCRF development.
Experience managing Biomarker, Imaging, and eCOA data.
Experience working with CROs or pharmaceutical companies.
Vendor management and cross-functional collaboration experience.
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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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Oklahoma City |Puerto Rico :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
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Basel | Zurich |Serbia :
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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 :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Dún Laoghaire |Galway :
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China | Quarry Bay |Liaoning :
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Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote 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 :
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Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Uxbridge | Renfrew | Mississauga | North York | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Croatia |Zagreb :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Seoul |Kazakhstan :
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Niš |Bohemia :
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