Job Description

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Develop and oversee project level data management strategy.
• Oversee CRO data management activities that support clinical trials.
• Provide expertise to clinical development functions in data capture, handling, and data management processes.
• In-study management for data management activities for Janux clinical studies, including coordinating tasks and deliverables across multiple clinical trials.
• Evaluate Electronic Data Capture (EDC) and eSource data capture (ePRO) for implementation.
• Contribute toward the drafting and implementation of Data Management Standard Operating Procedures (SOP) in collaboration with cross functional teams per regulatory requirements (ICH/GCP/CFR) and uphold industry standards in vendor outputs (SDTM/CDISC and CDASH).
• Act as primary Data Management contact for assigned projects to cross functional teams.
• Review clinical documents (eg. Protocols, Case Report Forms, Statistical analysis outputs, and clinical study report).
• Review and/or develop all core Data Management Documents, including but not limited to Data Management Plans, eCRF Specifications, Data Validation Specifications, CRF Completion Guidelines, Data Transfer Agreement(s) (DTAs), Data Review Plans, and Data Integration Specifications for clinical studies.
• Assist in and/or oversee external data reconciliations (SAE, central labs, etc.).
• Oversee and approve the User Acceptance Testing (UAT) of EDC, including relevant documents as 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.
• 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

• Bachelor’s degree required, advanced degree preferred. A degree in Biomedical or Life Sciences is preferred.
• 6+ years of Data Management in pharmaceutical, biotech, and/or CRO, including 3 years of Management experience, including 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 coordinate and drive delivery of 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.