Competitive salary; not specified; extensive benef...
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Expert knowledge of cdisc standards
Experience with sdtm and adam
6 years pharmaceutical data management experience
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Johnson & Johnson is seeking a Manager, Standards Management (DAS/TFL) to lead and support the development of clinical data standards within their Integrated Data Analytics & Reporting team. The role requires expertise in clinical data management and regulatory compliance, with a focus on innovation and collaboration across multiple locations.
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Job Summary
The role involves establishing programs and strategies to advance the Clinical Data Standards organization while ensuring compliance with regulatory requirements.
Candidates will develop clear specifications for standard content across the data lifecycle, including protocols, statistical analysis plans, and data presentation specifications.
Johnson & Johnson offers a competitive salary, extensive benefits, and a flexible working environment that values work-life balance.
Matching Summary
Match Score: 75
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Johnson & Johnson is seeking a Manager, Standards Management (DAS/TFL) to lead and support the development of clinical data standards within their Integrated Data Analytics & Reporting team. The role requires expertise in clinical data management and regulatory compliance, with a focus on innovation and collaboration across multiple locations.
**
Salary
Competitive salary; Not specified; Extensive benefits package
Skills & Requirements
Must-have
Expert knowledge of CDISC standards
Experience with SDTM and ADaM
6 years pharmaceutical data management experience
Proficiency in SAS and Pinnacle 21 tools
Understanding of GCP and ICH regulatory requirements
Nice-to-have
Knowledge of HL7 FHIR and OHDSI OMOP
Experience with AUTOCODE tool
Leadership in cross-functional initiatives
Ability to coach junior colleagues
Innovation in clinical data processes
Key Requirements
Bachelor's degree in scientific or healthcare discipline
Master's or PhD preferred
At least 6 years relevant pharmaceutical experience