Senior Manager, Clinical Data Management

Job Description

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. 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. 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. #J-18808-Ljbffr