Director, Clinical Data Management

Required Skills & Experience

• Bachelor’s degree or higher in a scientific or healthcare discipline (advanced degree a plus), with 10+ years of progressive experience in data management within biotech, pharmaceutical, or CRO settings, including prior line-management / people leadership experience. Rare Disease and Neurology trial experience are highly desirable.
• Proficient in clinical data collection, cleaning and analysis for Phase I- IV clinical trials in the pharmaceutical industry
• Experience working in an outsourced data management model
• Knowledge of and experience with EDC databases CDISC standards (CDASH, SDTM and ADaM, including Define-XML), medical terminology, medical coding dictionaries (MedDRA, WHODrug), and quality control processes
• Working knowledge of GCP E6(R3), 21 CFR Part 11 and applicable FDA/EMA requirements, including risk-based quality management and data integrity (ALCOA+) principles
• Prior experience filing a BLA or NDA preferred
• 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.
• Strong experience in early phase drug development and rare diseases required
• Microsoft Applications (Outlook, Word, Excel, PowerPoint, Project, Visio)
• In depth knowledge of clinical data management systems (eg: Medidata Rave Veeva Vault CDMS) required; working familiarity with data review, visualization, and analytics tools (e.g., SAS, R/Python, Spotfire, Power BI, J-Review, or elluminate)

• Accountable for data management activities for Stoke clinical studies and oversee CRO data management activities that support ongoing clinical programs.
• Oversee data management activities for one or more product/programs, consisting of multiple clinical studies
• Manage a best in class Data Management team, consisting of highly qualified and experienced data managers
• Balance resources, and ensure appropriate levels to support organization activities (current and future)
• Manage budgets and expenses, including budget projections
• Support inspection readiness, quality compliance, and training initiatives pertaining to Data Management activities
• Create SOP’s and standards for Data Management to support Stoke’s development programs
• Develop the Data Management Plan (DMP) across programs and maintain throughout lifecycle of study project to ensure DMP is followed according to study design and requirements.
• Review clinical research documents (e.g. Protocols, Case Report Forms, Reports and Statistical analysis).
• Review DB clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
• Review Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
• Reconcile electronic data transfers from vendor to Sponsor.
• Oversee the User Acceptance Testing (UAT) by CRO and Coordinating UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
• Maintain/track EDC user management and other Clinical databases across allocated Clinical trials.
• Ensure clinical data within EDC is of high quality to support lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
• Accountable for eCOA (eDiary/ePRO/ClinRO/ObsRO), wearable and sensor data, and other electronic data collection methods to make sure the design of data collection meets the scientific objective.
• Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
• Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
• Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB.
• Coordinate and communicate with DB vendors on consistent basis to address. Clinical team’s requests, project plans, and/or eCRF development activities.
• Participates in the preparation and presentation of data, when applicable.
• Ensure data system compliance by following the established guidelines of national and international regulatory authorities. Helps to identify and troubleshoot operational problems, issues, obstacles, and barriers for studies and programs; Working with appropriate teams towards action and ensuring resolution
• Establish and oversee a risk-based quality management (RBQM) approach to clinical data, including the definition and ongoing monitoring of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) in line with ICH E6(R3).
• Drive data-driven oversight through centralized monitoring, data analytics, and review dashboards/metrics (e.g., Spotfire, Power BI, J-Review) to detect anomalies, outliers, and trends across studies.
• Ensure data integrity and 21 CFR Part 11 compliance across EDC and external data sources, applying ALCOA+ principles and current computer system validation/assurance (CSV/CSA) expectations.
• Promote standardization and automation (e.g., SAS, R, or Python) and evaluate emerging AI/ML-enabled tooling to improve the efficiency, consistency, and quality of data review and reporting