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About the Role

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

Responsibilities

Participate in the development and maintenance of global clinical data standards, including operational data mappings.
Develop operational mappings utilizing CDISC SDTM, controlled terminology, and other applicable industry standards.
Act as a Subject Matter Expert on operational data standards utilizing SDTM standards and CDISC controlled terminology.
Contribute 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.
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.
Manage 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.
Build, maintain, and document Medidata Rave global library standard objects to facilitate study-level database creation.
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.
Support and participate in the Standards Core Committee (SCC).
Partner with functional area stewards.
Organize standards topics for review and ensure timely decisions.
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 comments until approval.
Follow procedural documents and participate in reviewing and updating them.
Communicate and reinforce content and interpretation of Kite data standards to project and study teams.
Participate in relevant study and project team meetings as standards SME and provide input for standards components.
Liaise with and review work delivered by external partners.
Develop strong working relationships with key stakeholders throughout CDMs, Clinical Ops, and Kite.
Participate and/or lead in strategic initiatives, special projects, and working groups.
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.
Represent the Company in interactions with key external partners.

Requirements

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.

Skills

Medidata RAVE
Medidata RAVE Custom Functions
C# programming
Standards Governance (CDISC)
CDISC SDTM
CDISC controlled terminology
Medidata Rave global library standard objects (e.g., eCRF forms, edit checks)
CRF Completion Guidelines
Industry Standards (e.g., CDISC) in collection (CDASH), tabulation (SDTM), or analysis (ADaM) models
Clinical database developer experience in Rave
Global library development
Development of standard data collection objects
Drug development process
Clinical trial execution
Global library development/clinical database development in a global arena
EDC tools (e.g., Medidata Rave, Veeva, Medrio, Oracle, TrialGrid)
Database and dictionary structures (e.g., MedDRA, WHODrug)
Interpreting Health Authority regulations and GCP/ICH guidelines
Compliance background
Pharmaceutical development process
SDTM
Creating data mapping specifications
Annotated CRFs
Define.xml
CRF design
Query resolution
General data validation
Systems Development LifeCycle (SDLC) principles
Verbal and written communication skills
Ability to communicate standards-related issues, options, and their impact
Technical expertise
Technical writing ability
Credible interface to global development and business partners
Influential leadership
Communication capabilities
Engage, manage, develop and inspire a geographically diverse team

Location

Remote

Work Type

Full-time

Experience Level

4+ years of experience in Clinical Data Standards
6+ years of experience in Clinical Data Standards
10+ years of experience in Clinical Data Standards
At least 6 years of relevant industry experience with clinical trials
At least 8 years of clinical database developer experience in Rave

Education Level

Meditdata MS/MA in life sciences or related discipline
BS/BA in life science or related discipline
High School degree
MS/MA in life sciences or related discipline

Salary/Compensations

$84,600.00 - $211,600.00

Benefits

Health and welfare benefits
Other benefits
Incentive plans
Bonuses

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Learn more at https://jobs.iqvia.com

Equal Opportunity

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.