Manager, Clinical Data Management

Vir Biotechnology, Inc. is an immunology firm with a focus on integrating advanced technologies for the treatment and prevention of infectious diseases and other serious conditions. Vir has developed two technology platforms designed to stimulate and enhance the immune system by utilizing critical observations of natural immune processes. Our current clinical development pipeline includes product candidates targeting hepatitis B and hepatitis delta viruses, influenza A and B, the human immunodeficiency virus, and COVID-19. We also have several preclinical candidates in our pipeline, such as RSV/MPV and HPV. We are firm believers that our colleagues' success drives the success of our mission. We strive to build a company that is passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to contribute their best, we will collectively achieve exceptional results. We take pride in being ranked the fastest-growing company in North America on the 2022 Deloitte Technology Fast 500™. Vir Biotechnology is seeking an experienced Manager for Clinical Data Management to join our Clinical Development team. As a remote employee, you will report to the Associate Director of Clinical Data Management. Your role will be to support the in-house and outsourced clinical data management activities to assure the integrity and quality of our clinical research data. Furthermore, you will contribute to and implement clinical data management best practices to ensure suitable data collection and delivery of complete, high-quality, and reliable clinical trial data. Responsibilities and Learning Opportunities: - Manage the execution of contractual tasks by Contract Research Organizations (CRO) and vendors from study start-up till study closure, including the review/approval of data management plans, data review plans, CRF completion guidelines, data transfer agreements, and Clinical Data Management eTMF documentation for GDP compliance. - Supervise/lead the design of eCRF, database development, programming of check specifications, UAT and migration testing, data integrations, data cleaning, and reconciliation processes. - Monitor/participate in the progress and conduct of study projects, including data cleaning and QC activities to ensure all deliverables meet the project timelines. - Liaise with internal and external teams for Data Management, Biostatistics, Statistical Programming, Clinical Operations, Clinical Science/Research, Pharmacovigilance, and other relevant functional groups to meet project deliverables. - Participate in inspection readiness, quality compliance, and training initiatives related to Clinical Data Management. Qualifications and Experience: - A Bachelor's degree and 8+ years, or a Master's degree and 6+ years, or a PhD and 3+ years of experience preferred. - Proficient in clinical data management, clinical trial process, medical terminology, TMF best practices, and industry standards and guidelines including ICH, GCP, CDASH/CDISC. - Knowledgeable in eCRF design and database development from protocol review and interpretation, database validation, data integration, and external vendor data handling, and data review process. - Experience in reviewing, interpreting, and evaluating clinical data for database lock readiness. - Experience in providing oversight for CROs/study vendors to ensure completeness, correctness, and consistency of clinical trial data. Vir's compensation and benefits align with the current market and are commensurate with each person’s experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity, health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match, and lunch for all onsite personnel! Vir is an equal opportunity employer. We value diversity in our company and do not discriminate based on race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and employment privileges. Please contact Human Resources for accommodation requests. Please note that Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not establish any type of relationship between the recruiter and Vir, nor do they oblige Vir to pay fees should we hire from those resumes. We respectfully request that external recruiters and/or agencies refrain from contacting or presenting candidates directly to our hiring manager or employees. Please check our Candidate Privacy Notice.