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Roles and Responsibilities:

Study Level Support:

• Create and manage CRF study metadata in the Metadata Repository (MDR).
• Participate in study set-up activities and coordinate with internal stakeholders and CROs.
• Create the new study CRF in RAVE medidata eDC
• Manage exemptions to standards for CRF and SDTM
• Ensure compliance with regulatory requirements during SDTM package creation and implementation for outsourced studies.

Standard Management Support:

• Develop, maintain, and optimize data standards, ensuring compliance with CDISC and health authority requirements.
• Collaborate with cross-functional teams to define and optimize data standards and processes.
• Maintain the standard library in the metadata repository, including organizing releases and updates.

Submission Readiness Support:

• Assist in preparing SDTM packages for marketing authorization submissions, ensuring compliance with submission rules for outsourced studies.

Innovation and Continuous Improvement:

• Collaborate with stakeholders to optimize data standards and processes.
• Contribute to the implementation of new technologies and strategies to improve drug development speed and quality.

Mentorship and Leadership:

• Mentor junior team members and provide strategic guidance in data standards.
• Lead cross-functional collaborations to identify opportunities for innovation.

Required Skills:

• Educational Background: Advanced degree in Life Sciences, Mathematics, Computer Sciences, or equivalent experience.
• Experience: Minimum of 8 years in the pharmaceutical/biotechnology industry, with proven experience in data standards development and governance, CRF development or SDTM data creation.
• Technical Proficiency:
• Extensive knowledge of CDISC standards (SDTM, CDASH), data management systems, and programming languages (e.g., SAS, SQL).
• Familiarity with regulations and guidance related to clinical development (FDA, EMA, etc.).
• Expert in CRF design in Rave Medidata eDC
• Knowledge in using Ryze for CRF metadata
• Project Management: Experience in leading complex data management projects and a strong understanding of project management methodologies.
• Communication Skills: Excellent verbal and written communication skills, with the ability to convey complex information clearly.
• Analytical Skills: Strong analytical and problem-solving abilities to address data standardization challenges.

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