Manager, Clinical Data Management
Sep 19, 2023
Remote - United States
Vir Biotechnology, Inc. is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses, influenza A and B, human immunodeficiency virus and COVID-19. Vir has several preclinical candidates in its pipeline, including RSV/MPV and HPV.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results. We are proud to have been ranked the fastest-growing company in North America on the 2022 Deloitte Technology Fast 500™.
Vir Biotechnology is looking for an experienced Manager, Clinical Data Management to join our Clinical Development team. Working remotely, you will report to the Associate Director, Clinical Data Management and will provide support for clinical data management activities performed in-house and outsourced to ensure the integrity and quality of our clinical research data. Additionally, you will provide input and implement clinical data management best practices to ensure appropriate data collection and delivery of complete, high quality, and reliable clinical trial data.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES:
- Manage CROs/vendor’s execution of contractual tasks from study start-up to study closure; including the review/approval of data management plans, data review plans, CRF completion guidelines, data transfer agreements, and CDM eTMF documentation for GCP compliance.
- Oversee/Lead eCRF design, database development, edit check specification programming, UAT and migration testing, data integrations, data cleaning, and reconciliation processes.
- Monitor/Participate in the progress and conduct of the study projects, including data cleaning and QC activities to ensure all deliverables are on target per project timelines.
- Coordinate with internal and external Data Management, Biostatistics, Statistical Programming, Clinical Operations, Clinical Science/Research, Pharmacovigilance, and other relevant function groups to meet project deliverables.
- Participate in inspection readiness, quality compliance, and training initiatives related to Clinical Data Management.
QUALIFICATIONS AND EXPERIENCE:
- BA/BS and 8+ years of experience or MS and 6+ years of experience or PhD and 3+ years of experience preferred.
- Command of clinical data management, clinical trial process, medical terminology, TMF best practices, and industry standards and guidelines including ICH, GCP, CDASH/CDISC.
- Knowledge 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 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 are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for 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 at our company. We do not discriminate on the basis of 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 critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
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