Position Details
About this role
This role involves leading external data management activities within a pharmaceutical setting, ensuring regulatory compliance and data quality.
Key Responsibilities
- Shape and implement data strategies
- Lead and mentor teams
- Oversee SOP development
- Manage external vendor relationships
- Ensure regulatory compliance
Technical Overview
Focus on data extraction and management using SAS, CSV, XML, with adherence to industry standards like 21 CFR Part 11 and CDISC.
Ideal Candidate
The ideal candidate is a senior data management professional with extensive experience in external data processes within the pharmaceutical or biotech industry, knowledgeable about regulatory standards like 21 CFR Part 11 and CDISC, and skilled in SAS, CSV, and XML data extraction. They possess leadership qualities and can mentor teams effectively.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience with 21 CFR Part 11, ICH-GCP, or CDISC standards, No prior leadership or mentoring experience, Inability to work in a hybrid environment with multiple locations
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