Associate Director, Data Management

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Provide leadership, and expertise to clinical development functions in data capture, handling, and data management processes
• Accountability for data management activities for Janux clinical studies, coordinating tasks and deliverables across multiple clinical trials
• Evaluate Electronic Data Capture (EDC) and eSource data capture (ePRO) for implementation.
• Develop Standard Operating Procedures (SOP) in collaboration with cross functional teams per regulatory requirements (ICH/GCP/CFR) and implement industry standards (SDTM/CDISC and CDASH). Lead The development of standard CRF library for Janux and coordinate cross functional team review of standard forms
• Develop and oversee project level data management strategy
• Oversee CRO data management activities that support clinical trials
• Act as primary Data Management contact for projects to cross functional teams
• Review clinical development documents (eg. Protocols, Case Report Forms, Statistical analysis outputs, and clinical study report)
• Review/develop/approve all core Data Management Documents, including but not limited to Data Management Plans, eCRF Specifications, Data Validation Specifications, CRF Completion Guidelines, and Data Transfer Agreement(s) (DTAs), Data Review Plans and Data Integration Specifications for clinical studies
• Assist/oversee external data reconciliations (SAE, central labs, etc.)
• Oversee and approve the User Acceptance Testing (UAT) of EDC including relevant documents if needed due to protocol amendments or study needs
• Ensure clinical data within EDC is of high quality for statistical review, interim review, and/or final database lock. Coordinate data reviews between cross functional teams at Janux
• Manage projects assuring timeline and budgetary compliance in data management
• Recruit and manage Data Management staff to support clinical development programs including function vision and goals aligned with corporate goals for each direct report
• Participates in the preparation and presentation of data, when applicable. Represent Data Management in Sponsor/Regulatory Agency assessments and/or audits
• Up to 20% travel may be required based upon business needs
• Perform other tasks as necessary

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

• Minimum bachelor's degree required, Advance degree preferred. A degree in Biomedical or Life Sciences is preferred.
• 8+ years of Data Management in the pharmaceutical, biotech, and/or CRO with 4+ years in a managerial role, to include vendor oversight.
• Advanced knowledge of data management process for clinical trials and the applicable regulations, experience in oncology and early phase studies required.
• Ability to direct and manage the activities of outside Data Management vendors.
• Knowledge of and experience with EDC databases (especially Medidata Rave) integrations between EDC and IRT systems, CDASH/SDTM standards, medical terminology, medical coding dictionaries, data reconciliations, and quality control processes.
• Knowledge and understanding of GCP, ICH and FDA requirements as applicable for Clinical Data Management (CDM).
• Ability to manage multiple initiatives and shift priorities within a small biotech environment.
• Excellent interpersonal skills, strong verbal and written communication skills with the ability to work independently and collaboratively in a dynamic team environment.