Manager / Senior Manager, Clinical Data Management

Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking a Manager / Sr. Manager of Clinical Data Management and will report to the Director Clinical Data Management. The candidate will oversee Data Management activities for Phase I-IV studies and ensure product and study level deliverables are completed on time, with high quality, and following corporate and regulatory requirements. This position will participate as an active multi-disciplinary team member to plan, lead, and execute the Data Management tasks required for Phase I-IV studies. Expert knowledge of FDA regulations and general industry standards is necessary to support departmental infrastructure development.

Kezar is focused on small-molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar’s lead product candidate, KZR-616, a selective inhibitor of the immunoproteasome, is being evaluated in Phase 2 clinical trials for the treatment of severe autoimmune diseases. KZR-261, Kezar’s first oncology candidate targeting the protein secretion pathway via the Sec61 translocon, is now being studied in a Phase 1 clinical trial in several oncology indications.

RESPONSIBILITIES

• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO/vendor counterparts
• Review protocols for appropriate data capture, including electronic CRF design
• Lead database upgrades / migrations, including performing User Acceptance Testing
• Oversee / develop data management documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, data flow, and integrity plans, and Data Review Plans
• Able to review and provide feedback to the multi-disciplinary team on other study documents, e.g., Protocol Deviation Management Plan, Statistical Analysis Plan, and vendor specifications
• Participate in regular team meetings and provide input when appropriate
• Understand critical tasks and milestones; ensure data management deliverables are met per study timelines

• Manage the clinical study budget, ensuring the project remains within scope through reviewing and approving invoices, identifying out-of-scope activities, and its appropriate handling
• Conduct CRO data management function inspections and audits
• Contribute to developing and implementing departmental policies, standards, and process improvement initiatives
• Provide input into the development of data management SOPs, Work Instructions, and process documents
• Support implementation of data standards
• Align with and support management and corporate objectives
• Communicate and message information to multiple levels of leadership appropriately and apply the appropriate level of detail to the audience to ensure efficient utilization of resources
• Assist in selecting vendors / CROs (e.g., reviewing RFPs, and attending site audits). Assist with training of new employees and / or contractors.
• Other duties as assigned

REQUIREMENTS

• Bachelor’s degree in a scientific or health care discipline; Master’s degree is a plus
• At least 5 years’ experience in Data Management for the pharmaceutical / biotechnology industry or equivalent experience in an FDA- regulated environment, including study lead experience
• Technologically savvy; quickly picks up on new information, standards, regulations, tools, methods, or software related to position and profession
• Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH / FDA guidance, CDISC Standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, EDC Development, UAT, etc.) and their application to Data Management practice
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Possess solid computer system and technical skills with a strong ability to learn multiple computer applications
• Understands the scope and focus of Phase I-IV clinical studies and has a proven ability to perform most of the core Data Management tasks and interact with vendors
• Prior experience with different Data Management systems, technologies, Electronic Data Capture systems, and IRT- Medidata Rave, Medrio, Endpoint, Bracket- is desirable
• Ability to lead, train, and mentor team members at all levels
• Able to travel to off-site meetings or training seminars as needed and under current COVID-19 guidelines

Kezar Life Sciences is an Equal Opportunity Employer