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:
o Extensive knowledge of CDISC standards (SDTM, CDASH), data management systems, and programming languages (e.g., SAS, SQL).
o Familiarity with regulations and guidance related to clinical development (FDA, EMA, etc.).
o Expert in CRF design in Rave Medidata eDC.
o 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.
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