Clinical Data Manager (CDM)
Kezar Life Sciences, United States
Job Description
Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking a Clinical Data Manager and will report to the Sr. Manager, Clinical Data Management. The candidate will be responsible for assisting Lead DM with overseeing 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. Expert knowledge of FDA regulations and general industry standards is necessary to support departmental infrastructure development. The expectation is to be onsite at our South San Francisco, CA office at least three days per week.
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
- Assist Lead DM to 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.
- Assist Lead with database upgrades / migrations, including performing User Acceptance Testing
- Responsible for Assisting/ Overseeing / developing 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
- Perform discrepancy and query management in Medidata Rave
- Proactively identifies potential study issues/risks and recommends/implements solutions.
- 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.
- Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal.
- Participate in regular team meetings and provide input when appropriate.
- Understand critical tasks and milestones; ensure data management deliverables are met per study timelines.
- 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.
- Other duties as assigned.
Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants. You are encouraged to apply even if you do not meet each of the listed preferred qualifications.
REQUIREMENTS
- Bachelor’s degree in a scientific or health care discipline; master’s degree is a plus.
- At least 4 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.
- Able to travel to off-site meetings or training seminars as needed and under current COVID-19 guidelines.
Compensation and Benefits
The salary range for this position as Clinical Data Manager at our South San Francisco, CA corporate office is $120,000 - $130,000. Factors such as academic