Senior Manager, Clinical Programming – Clinical Data Standards Management

Role Overview

• Participate in the development and maintenance of global clinical data standards, including operational (eCRF and non-eCRF) 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.
• 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.
• Subject Matter Expert (SME) on operational data standards utilizing SDTM standards and CDISC controlled terminology in developing operational data standards.
• Support and participate in the Standards Core Committee (SCC).
• Partner with functional area stewards and 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.
• 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.
• Build and maintain CRF Completion Guidelines for all standard forms.
• 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.
• Participate in relevant study and project team meetings as standards SME and provide input for standards components.

Requirements

• PhD in life sciences or related discipline and 2+ years of experience OR MS/MA in life sciences or related discipline and 6+ years of experience in Clinical Data Standards OR BS/BA in life science or related discipline and 8+ years of experience in Clinical Data Standards OR High School degree and 12+ years of experience in Clinical Data Standards
• MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Data Standards preferred
• 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.

Tech Stack

• Google Cloud Platform
• Oracle
• SDLC

Benefits

• Company-sponsored medical insurance
• Company-sponsored dental insurance
• Company-sponsored vision insurance
• Company-sponsored life insurance plans
• Paid time off
• Discretionary annual bonus
• Discretionary stock-based long-term incentives