Senior Clinical Data Associate - Risk-Based Quality Monitoring

3 days ago

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Cytokinetics

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Heart Failure • Amyotrophic Lateral Sclerosis • Hypertrophic Cardiomyopathy

201 - 500

💰 $450M Post-IPO Debt on 2022-06

Description

• Cytokinetics focuses on discovering, developing, and commercializing first-in-class muscle activators and inhibitors. • Oversee all RBQM-related data management activities for projects according to ICH/GCP. • Ensure compliance with policies and clinical study objectives. • Serve as primary data management representative in project teams. • Manage and collaborate with CROs to meet deliverables and timelines. • Monitor RBQM processes and CRO performance. • Ensure clinical data quality meets regulatory submission standards. • Work with CROs to generate metric reports and deliverables.

Requirements

• S./B.A. in a science or technical discipline degree with 6 years Clinical data management experiences, or M.S./Ph.D./M.D. degree with 4 years Clinical data management experiences • Familiar with clinical trial life cycle, proficient in clinical data collection, cleaning and locking for Phase I- IV clinical trials in a pharmaceutical industry/CRO • Prior experience working with RBQM methodologies, TSDV configuration and management, establishment of KRIs and QTLs, and central monitoring modalities is required • Working knowledge of ICH/Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP), and related regulatory requirements. CCDM is preferred but not required • Working knowledge of CDISC CDASH/SDTM standards, medical terminology, and medical coding dictionaries: MEDDRA and WHODRUG • Working knowledge of different EDC and TSDV platforms and data collection systems (e.g. IRT, ePRO, etc.) • Prior experience supporting a BLA or NDA filing preferred but not required • Experience managing CRO vendors • Ability to manage multiple initiatives and shifting priorities within a small company environment • Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment