Requisition Number: R&D17548
Job Title: Manager, Metadata Curation
Interest Category: Research & Development
Interest: Clinical Research
Department: Head of Platform
State: New Jersey
City: Bridgewater
Job Description: Job Summary:
Lead global metadata curation and governance activities in collaboration with functional area representatives and technical harmonization experts. The incumbent metadata expert ensures the implementation of new and updated clinical metadata and master data is properly assessed and implemented in all upcoming clinical systems (Clinical Technology Convergence, Maestro, etc.) according to service level agreements with the highest quality.
Major Duties & Responsibilities:
- Leads definition of metadata governance principles, processes, policies and procedures
- Proactively reaches out and establishes network of global, cross-functional staff to participate in metadata governance activities including regularly interact with senior functional area representatives.
- Proactively reaches out and establishes network of global, cross-functional staff to participate in metadata governance activities
- Participates in the Standardization Core Team/Standard Council meetings, as required. Lead discussions around metadata management and governance.
- Participates in the Standards Governance Organization (SGO) meetings, as required. Leads discussions around metadata management and governance.
- Educates others on metadata, vocabularies, information models and ontologies as well as best practices for metadata management.
- Takes a strong leadership role in metadata requirements gathering sessions.
- Reviews and evaluates proposals for new metadata and proposed metadata changes to endorsed standards (e.g., study-specific, product-specific or global). Checks for:
• Completeness
• Quality
• internal consistency – within a project
• external consistency – with other projects and other external sources
- Ensures harmonization with information models adopted (such as BRIDG and HL7 RIM) to promote “Computable Semantic Interoperability” between internal and external systems
- Leads the overall review by global, cross-functional representatives of proposed changes and additions to the Metadata Repository.
• Includes reviewing proposals, monitoring of review comments, and determining whether conflicting comments require escalation in order to be resolved. Coordinates escalation reviews to resolution.
- Leads the overall review by global, cross-functional representatives of proposed changes and additions to the Metadata Repository.
• Includes reviewing proposals, monitoring of review comments, and determining whether conflicting comments require escalation in order to be resolved. Coordinates escalation reviews to resolution.
Major Challenges/Problems:
1. In cooperation with the standard committee, define the right level of standardization to simultaneously ensure business effectiveness, regulatory compliance and flexibility according to study needs.
2. Maintain the standard library databases error-free
3. Document and communicate any changes at in standard libraries
Key Internal/External Relationships:
all groups of Technology and Information Management
Key External Relationships: Trial Operations, Medical Operations, CEP, Q&CI, GPE, PK,
Decision Making Authority:
Implement agreed standard modules and study specific objects
Identify, communicate and solve issues/problems/non-standard compliance
Initiate/propose new processes to continuously improve quality and efficiency
Inform the Domain Manager when conflicts of priority occurs
Requirements: Formal Education & Experience Required:
• Bachelor’s degree (required) / Advanced degree (preferred), in relevant field (such as Computer Science, Informatics, Information Management, Library Science, Nursing or Medicine) or equivalent experience.
• 8-10 years relevant life sciences industry experience
• Experience working in a global team environment
Knowledge & Skills Needed:
• Ability to effectively communicate (verbally and in writing) and obtain buy-in with many levels across the organization.
• Expertise of Clinical Data Management Systems and processes
• Strong ability to negotiate and gain acceptance of others (sometimes very senior) in time-sensitive, high pressure situations.
• Organized, attentive to detail and able to work under deadlines.
• Ability to assimilate and prioritize requests from multiple individuals and organizations.
• Works independently with moderate amount of supervision.
• Works effectively across different lines of business.
• General computer applications; such Windows and Microsoft Office.
• Strong expertise and knowledge of CDISC standards and terminologies including experience implementing them in a real world environment that demonstrates both technological and business process aptitude is mandatory.
• Fluent in English
Knowledge & Skills Desirable but Not Essential:
• Additional knowledge and expertise with HL7 RIM is preferred, but, not mandatory. Selected candidate would need to come up to speed quickly.
• Understanding and experience with relevant terminologies (such as, SNOMED CT, WHO, MedDRA, RxNORM, LOINC, etc.) and ISO Data Types is highly desirable. Selected candidate would need to come up to speed quickly.
• Understanding and experience with Life Sciences Industry Information Models based on UML (such as BRIDG) is highly desirable. Selected candidate would need to come up to speed quickly.
• Understanding and experience with XML for exchange of metadata (such as CDISC ODM or HL7 messaging). Selected candidate would need to come up to speed quickly.
• Understanding of semantic web concepts and the Ontology Web Language (OWL) is highly desirable. Understanding and experience with life sciences standards and ontologies (such as W3C TMO, FGED, HUPO, BIOMOBY, ICH, ISO, CEN, DICOM, Office of the National Coordinator (ONC) and National Health Standards, etc.)
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