Job Description

Meet is working with a pre-IPO biotech here in the Bay Area, looking to hire an Associate Director of Data Management! Reporting to the Director of Clinical Development, you would lead the DM function as the first in-house hire.

QUALIFICATIONS:

• 8+ years of relevant experience and has earned a BS or equivalent degree; MS or MBA a plus
• Experience running Ph I-IV clinical trials, through CRO partners (rare disease and retrospective study experience is a plus)
• Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization)
• Understanding of Good Clinical Data Management Practices
• Proficiency in CDISC standards (CDASH, SDTM, ADaM)
• Experience with SAS, SQL and/or other clinical programming tools
• Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP
• Depth of experience across all aspects of DM, including but not limited to: CRF and database development, data quality assurance and analytics, data transfer management, external vendor management, DM study documentation and inspection readiness.
• Strong understanding of the application of MedDRA and WHO Drug clinical data coding classification systems

Please apply directly if your experience aligns!

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