Manager, Clinical Programming - Clinical Data Standards Management

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Job Description

Responsibilities (include but are not limited to): 

• 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.

• 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.

• 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

• 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

• 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

• 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, such as CRF design, CRF Completion Guidelines, programmed edit checks, Data transfer specifications, mapping specifications, and annotated CRF

• 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

• Liaising with and reviewing work delivered by external partners (e.g., Function Service Providers, CROs, technology providers, etc.)

• 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

• 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

• 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 ext