Job Title: Senior Manager, Clinical Data Management Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody designed to neutralize infection with BK virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com. Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do-from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases. Position Summary: Reporting to the Executive Director, CDM, the Senior Manager, CDM will be a highly motivated, quality-focused individual who can work collaboratively in a fast-paced, cross-functional team environment, and will oversee data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives and corporate goals. The Clinical Data Management (CDM) department plays an integral role as part of the cross-functional study team. CDM are responsible for the collection, organization, and integrity of data collected as part of our clinical trials. Responsibilities: * Act as the single point of contact for all study related data management deliverables across multiple studies. * Represent CDM in cross-functional meetings. * Cultivate effective and productive working relationships with peers and vendors. * Help develop timelines for data cleaning processes to maintain data integrity. * Provide input into the development of vendor/contract research organization (CRO) requests for proposal, scopes of work, and onboarding. * Manage CDM vendor/CRO service activities in a fully outsourced model from study build to database lock. * Ensure complete and accurate CDM documentation on any given study. * Participate in study document reviews, such as clinical study protocols, statistical analysis plans, risk management plans, monitoring plans and analysis output review. * Provide oversight for clinical data flow with CRO and ancillary vendors including IRT, eCOA, central lab, imaging, and other systems and services, as needed. * Manage the CDM section of the Trial Master File. * Support the development of company SOPs and work instructions. * Support DM related activities associated with regulatory inspections/audits. * Assist with strategic planning activities for the CDM department. * Provide and present CDM plans and status reports to a broad audience. * Maintain awareness of CDM emerging trends and technology to help develop or enhance CDM department standards, operational procedures, and best practices. Qualifications: * Bachelor's degree with at least eight (8) years of relevant industry experience. * Very detail-oriented, thorough, and organized. * Demonstrated project management experience with ability to perform under tight timelines whilst balancing conflicting priorities. * Versatile communicative and strong interpersonal skills. * Ability to work effectively in both a team setting and independently. * Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices. * Understand data privacy requirements governing data collection of clinical trial data and information. * Proficient in Medidata Rave and/or other EDC platform study builds. * Experience of working with and managing CROs/external vendors. * Experience with contributing to the creation of SOPs, work instructions and guidelines preferred. * Experience with NDA/BLA activities preferred. * Experience with supporting regulatory inspection/audit preparation preferred. Vera Therapeutics Inc. is an equal opportunity employer. Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $144,000-$180,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience. At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays. Notice to Recruiters/Staffing Agencies Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Vera Therapeutics' receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees. Fraud Alert To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/ . Recruiters will always contact you using the domain of veratx.com. 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