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Janux Therapeutics · 23 hours ago

Senior Manager, Data Management

San Diego County, CA

Full-time

Onsite

Senior Level

$168K/yr - $175K/yr

6+ years exp

Janux Therapeutics is searching for a Senior Manager of Data Management to manage day-to-day operations of data management activities. The Senior Manager will ensure compliance with regulatory requirements and industry standards to improve operational efficiency while managing activities with vendors to support oncology clinical trials.

BiotechnologyHealth DiagnosticsPharmaceuticalTherapeutics

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

Qualification

Data ManagementOncology ExperienceEDC KnowledgeRegulatory ComplianceVendor OversightClinical TrialsProject ManagementInterpersonal SkillsCommunication SkillsTeam Collaboration

Required

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