Requisition ID: CLI008253
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Metadata Curator ensures the quality, harmonization, and maintenance of industry and Merck-defined clinical data standards in the metadata management library. The Metadata Curator is also responsible for facilitating workflows and impact assessments of changes to clinical data standards, including new and up-versioned industry standards. Coordination of system implementation, reporting of standards adherence metrics, and supporting stakeholder use of information within the metadata repository will also be key to the position.
Primary activities include, but are not limited to:
- Manage the definition, maintenance, use and retirement of global and study-level clinical standards metadata within the metadata repository.
- Work with subject matter experts within the standards governance framework to ensure comprehensive end-to-end metadata requirements to enhance the use of CDISC standards and facilitate the production of submission deliverables complaint with health authority regulations
- Be the liaison between the business and technical teams
- Lead cross-functional teams to engage with impact analysis of changes to clinical data definitions.
- Work with subject matter experts within the standards governance framework to ensure comprehensive end-to-end metadata understanding
- Be a liaison between the business and technical teams for trends in metadata impact requests
- Define, implement, track and report on metadata metrics, including conformance to standards, opportunities for future curation, and impact of moving to new standards
- Analyze data collection design and recommend data flow components solutions based on understanding of relationships between data collection and downstream systems
- Provide training and lead user-group activities to promote the use and understanding of information in the metadata repository
- Learn new reporting techniques, and act as the liaison between the MDR and other Merck teams who wish to learn and utilize the information stored in the metadata repository
- Lead/participate in departmental, cross-functional initiatives, data governance reviews, projects and process improvement activities
- Maintain knowledge of new technologies, clinical information industry standards, regulatory requirements, and Merck guidelines and SOPs
- Able to work independently or as a team member or leader with equal effectiveness. Interacts with staff across multiple Merck sites.
Education Minimum Requirement:
B.A. or B.S. degree, preferably in life sciences, computer science or related field
Required Experience and Skills:
- 8+ years' work experience which includes 4 years of data analytics experience and a minimum of 2 years clinical data standards development; or advanced degree with 6+ years' work experience of which 2 years need to be in clinical data standards development
- A broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval) and worldwide regulatory data management and reporting requirements.
- Advanced knowledge and leading-edge skills in clinical data standards (e.g., CDISC) CDISC Study Data Tabulation Model (SDTM) expertise
- Electronic Data Capture knowledge (e.g. InForm)
- Analysis and Reporting experience
- Ability to effectively organize and manage multiple assignments with challenging timelines.
- Strong knowledge of the Drug Development Process, ICH and GCP guidelines
- Exceptional communication skills (oral and written), with the ability to communicate with technical and business subject matter experts
- Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects.
Preferred Experience and Skills:
- Extensive analytics experience, providing innovative approaches to visualizing and using information
- Technical implementation experience gathering data from multiple sources and using appropriate tools to combine and analyze information
- Exceptional people and thought leadership skills, with the ability to think strategically and to influence others.
- In-depth knowledge of and direct experience implementing industry standards (e.g. Controlled Terminologies, CDISC CDASH, SDTM, ADaM, & HL7) and requirements for submission deliverables (e.g., SDRG, ADRG, Define.xml)
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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Job: Clinical Data Management
Other Locations: Upper Gwynedd, PA, US
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: no
Company Trade Name: Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark