Cynthia Rouser

Senior Clinical Data Manager @Syndax Pharmaceuticals

Marlborough, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Feb 2022 — Present

Senior Clinical Data Manager @Syndax Pharmaceuticals

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Provide oversight of external partners (e.g. CDM CROs, central laboratories, ECG Cor labs, dictionary coding service providers, etc.) to ensure consistency and quality are maintained across projects. Ensure clinical data management activities for clinical trials and regulatory submission projects are completed on time and with excellent quality. Collaborate with cross-functional study team members in the conduct of clinical trials. Oversee CDM processes with safety laboratory data management and dictionary coding for adverse events and medications.

EDUCATION

1985 — 1987

Wellesley College

English Language and Literature, General

SKILLS

Medical CodingMeddraOracle ClinicalInformMedical WritingTherapeutic AreasPharmacovigilanceCROValidationComputer System ValidationCrf DesignClinical Study DesignGood Clinical Practice (Gcp)CdiscClinical ResearchData ManagementClinical TrialsRegulatory SubmissionsEdcMedidataStandard Operating Procedure (Sop)Electronic Data Capture (Edc)SopCRO ManagementCtmsGcpClinical Data ManagementProtocolClinical DataBiostatisticsData ReviewRegulatory AffairsClinical Monitoring21 Cfr Part 11Clinical DevelopmentFda

ABOUT CYNTHIA ROUSER

Self-motivated and goal-oriented Clinical Data Manager with more than 20 years in data…

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Cynthia Rouser — Senior Clinical Data Manager at Syndax Pharmaceuticals in Marlborough, MA, US | Unifers