Clinical Data Manager CDM

Profile

**MEMBERS ONLY**SIGN UP NOW***. (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. Kezars 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, Kezars 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
Bachelors degree in a scientific or health care discipline; masters 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 credentials and relevant experience will influence the actual salary offered. In addition to a competitive market-based salary, **MEMBERS ONLY**SIGN UP NOW***. offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K. Additional information about our total rewards program can be found here: Join Our Team - **MEMBERS ONLY**SIGN UP NOW***. Inc.
About **MEMBERS ONLY**SIGN UP NOW***.
We are developing first-in-class, small molecule therapies designed to inhibit multiple disease-driving cellular pathways by targeting key intracellular proteins. Since inception, our mission has been to deliver unique treatments that can better the lives of patients fighting difficult-to-treat chronic diseases. Our team is passionate about discovering promising targets that were previously unidentified or undruggable and have the potential to change the treatment paradigm for a range of conditions. Here at Kezar, our employees are our greatest asset and are the drivers of the Companys success. Every day, our team of passionate professionals are converting scientific ideas to first-in-class assets that have the potential for significant clinical impact in the most difficult-to-treat diseases. Together, we are focused on the common mission of helping patients overcome their chronic conditions and live a better life. We believe in fostering a culture of trust and respect for all team members at all levels. Our employees are encouraged to question, exchange views and discover new ways to address issues and solve problems. We welcome differences in ideas, styles and practices to accomplish our goals. Hard working, innovative and compassionate are qualities every Kezar employee should possess and were always looking for equally dynamic and motivated individuals to join our team.
Information for Recruitment Agencies
**MEMBERS ONLY**SIGN UP NOW***. does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or **MEMBERS ONLY**SIGN UP NOW***. employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search. Your willingness to comply with this will significantly impact any decision we may make about doing business with you.
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