Brian Olender

Sr Director, Head, Clinical Data Management @Cytokinetics

San Jose, CA, US
EMAILS
b•••••••@cytokinetics.com
MOBILE NUMBERS
+14•••••••43

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WORK HISTORY

Aug 2024 — Present

Sr Director, Head, Clinical Data Management @Cytokinetics

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South San Francisco, CA, US

EDUCATION

1994 — 1997

Whitman College

Bachelor of Arts (B.A.), History

1992 — 1993

UCLA

Physical and Biological Anthropology

SKILLS

Regulatory SubmissionsLeadershipCrf DesignData ManagementCROProject ManagementValidationQuality AssurancePharmaceuticsClinical Data ManagementOracle ClinicalComputer System ValidationPharmaceutical IndustrySopFdaClinical Study DesignDrug DevelopmentGcpBiopharmaceuticalsMedical DevicesClinical ResearchCapaBiotechnologyLife SciencesSoftware DocumentationSdlcEdcTherapeutic AreasCtmsChange ControlRegulatory RequirementsVaccinesClinical DevelopmentManagement21 Cfr Part 11Clinical OperationsClinical TrialsCdiscOncologyProtocol

ABOUT BRIAN OLENDER

With over 20 years of management and 9 years of senior leadership experience in clinical data management and systems, I am passionate about delivering high-quality data and insights for innovative drug development. As the Head of Clinical Data Management at Cytokinetics, I oversee the strategic planning, execution, and compliance of clinical data operations across multiple therapeutic areas and regions.I have successfully built and managed multinational and FSP/CRO teams of data managers, programmers, and systems specialists, and established strong partnerships with external vendors and stakeholders. I have also implemented global standards and processes, and ensured adherence to industry regulations and best practices. My expertise in electronic data capture, software development life cycle, and systems validation has enabled me to optimize data acquisition and analysis for clinical trials and regulatory submissions.

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