Senior Clinical Data Associate-Risk-Based Quality Monitoring

The senior Clinical Data Associate – RBQM (Risk-Based Quality Monitoring) will be responsible for overseeing all RBQM-related data management activities for assigned projects in accordance with ICH/Good Clinical Practices (GCP), GDCMP and other relevant procedures and guidelines.  

This position is a chance to have an impact on the future of Cytokinetics and help us continue to grow!  You will pair closely with biometrics, Clinical Systems, QA, CQA, Clinical Research, Clinical Operations, and Drug Safety to ensure compliance with policies, procedures, and overall clinical study and organizational objectives. 

Responsibilities 

• Serve as primary data management representative supporting RBQM activities on cross-function project teams and ensure effective communication exchange
• Manage, collaborate, and act as the primary point of contact with CROs to ensure that study deliverables and timelines are met for outsourced studies
• Monitor Data Management RBQM processes and CRO performance
• Lead RBQM activities with external vendors ensuring timely reporting of Key Risk Indicators and Quality Tolerance Levels to allow for adaptive risk-based monitoring
• Assist study data management personnel with the configuration and management of Targeted Source Document Verification (TSDV) in EDC both at study start-up as well as throughout the conduct of studies as RBQM metrics are measured
• Conduct trainings for appropriate users of data management systems (e.g. EDC, RBQM reports, TSDV)
• Generate and/or review/approve study documents (e.g. Data Management Plans, RBQM reports and visualizations, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols)
• Ensure the quality of clinical data meets standards determined by RBQM KRIs and QTLs and is fit for regulatory submissions. Generate and/or implement the Data Review Plan (DRP) and/or Central Monitoring Plan defining and documenting the data quality review strategy for each clinical trial in collaboration with cross-functional team, enabling the quality review of patient data supporting regulatory filings, publications and other high-profile business activities
• Work with CROs to generate and/or distributes data management metrics, RBQM deliverables, data listings and status reports

Qualifications 

• 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