Systems engineer Jobs in Elizabeth, NJ

Mgr, Database Management Systems

Designs or modifies data models to solve complex database requirements considering business and application needs. Organizes metadata for use by teams.

Clinical Data Standards & Operational Mapping

• Participate in the development and maintenance of global clinical data standards, including operational (eCRF and non-eCRF (e.g., lab, Imaging, or ECG)) data mappings.
• To develop operational mappings, utilize Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), controlled terminology, and other applicable industry standards.
• SME on operational data standards utilizing SDTM standards and CDISC controlled terminology in developing operational data standards.
• Contributing to developing and applying smart systems and optimal approaches to support data collection.
• Independently identify and propose process improvements while maintaining a strategic focus. Share new industry standards and best practices with project and study teams and departments as required.
• Participate and/or lead in developing Global Clinical Data Standards and other cross-functional SOPs, Working Procedures, Guidance documents, and job aids.
• Participate and/or lead in identifying, reviewing, evaluating, and implementing new data standards-related technologies.

Global Library Management

• Managing work assignments to ensure timely delivery of global library objects.
• Identify and resolve issues that may negatively impact the delivery of global library objects and escalate to leadership as needed.
• Medidata Rave global library standard objects (e.g., eCRF forms, edit checks).
• Build, maintain, and document the Medidata Rave global library standard objects (e.g., eCRF forms, edit checks) to facilitate the creation of study-level databases.
• Work with Data Managers and EDC Programmers to implement new or modified global library objects (e.g., ensure DM and EDCP clearly understand global library objects).
• Build and maintain CRF Completion Guidelines for all standard forms.

Standards Governance & Committee Support

• Support and participate in the Standards Core Committee (SCC).
• Partner with functional area stewards.
• Organize standards topics to be reviewed and ensure decisions are made on time.
• Document meeting minutes and other discussions.
• Provide input and information to facilitate critical discussions and decisions regarding standards use and implementation.
• Support preparation of materials for the Standards Governance Committee (SGC) and address all comments received until all objects in scope get approved.

Process Compliance & Documentation

• Follow procedural documents and participate in reviewing and updating documents to ensure they reflect industry standards and are easily followed.
• Communicate and reinforce content and interpretation of Kite data standards to project and study teams to ensure consistency in understanding and implementing standards across a project.

Study & Project Team Support

• Participate in relevant study and project team meetings as standards SME and provide input for standards components, such as CRF design, CRF Completion Guidelines, programmed edit checks, Data transfer specifications, mapping specifications, and annotated CRF.
• Liaising with and reviewing work delivered by external partners (e.g., Function Service Providers, CROs, technology providers, etc.).

Stakeholder Engagement & Leadership

• Developing strong and productive working relationships with key stakeholders throughout CDMs, Clinical Ops, and Kite with the ability to think strategically across a broad portfolio and effectively express their views to senior management.
• Participate and/or lead in strategic initiatives, special projects, and working groups contributing to business decisions and process changes.
• Develop training materials and provide training on CDSM and GLIB-developed processes.
• Provide mentoring, coaching, and escalation support to more junior personnel or contract staff, as required.
• Representing the Company in interactions with key external partners as part of any committee or industry group.

Qualifications

Required Experience

• Medidata RAVE experience REQUIRED
• Medidata RAVE Custom Functions experience REQUIRED
• C# programming experience REQUIRED
• Standards Governance experience (CDISC) REQUIRED

Candidates whose resumes do not clearly demonstrate Medidata RAVE, Custom Functions, C#, and Standards Governance experience will not be progressed for review. These are mandatory requirements for consideration.

Minimum Qualifications

• Medidata MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Data Standards OR
• BS/BA in life science or related discipline and 6+ years of experience in Clinical Data Standards OR
• High School degree and 10+ years of experience in Clinical Data Standards.

Preferred Qualifications

• MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Data Standards OR
• At least 6 years of relevant industry experience with clinical trials and a successful track record of leading through influence, working across complex, global organizational matrices.
• Experience in Industry Standards (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models.
• At least 8 years of clinical database developer experience in Rave with expertise in global library development and development of standard data collection objects.
• Strong understanding of the drug development process with proven expertise in clinical trial execution and global library development/clinical database development in a global arena.
• Strong knowledge of industry-leading EDC tools (e.g., Medidata Rave, Veeva, Medrio, Oracle, TrialGrid, etc.) and well-versed in industry trends and emerging technologies supporting data collection.
• Understanding database and dictionary structures (e.g., MedDRA, WHODrug).
• Experience interpreting Health Authority regulations and GCP/ICH guidelines with a strong compliance background.
• Strong working knowledge of the overall pharmaceutical development process.
• Strong working knowledge of SDTM and creating data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml.
• Experience in CRF design, query resolution, and general data validation.
• Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
• Excellent verbal and written communication skills, high ability to communicate standards-related issues, options, and their impact to project teams and within the department.
• Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality, etc.).
• Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.