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Associate Director, Clinical Data Management

Company: Vir Biotechnology, Inc.
Location: San Francisco
Posted on: June 12, 2021

Job Description:

Vir is a clinical-stage immunology company with a compelling mission: "A World Without Infectious Disease". We are focused on combining immunologic insights with cutting-edge technologies. We have assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Our current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus.

We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.

Vir Biotechnology is seeking an experienced Associate Director, Clinical Data Management to join our Clinical Development team. This person will be reporting to the Director, Clinical Data Management and will be providing support to clinical data management activities across one or more clinical development programs enabling planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and marketing acceptance.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES:

  • Lead and manage CRO in all data management activities for multiple clinical development programs across different stages/phases of development.
  • Serve as the functional representative on project teams and strategic partnerships by providing data management timelines to coordinate and synchronize deliverables with the overall study timelines. Monitor progress and conduct of the study projects, including data cleaning and QC activities to ensure all deliverables are on target with project timelines.
  • Proactively assess risks and develop solutions to complex problems.
  • Lead continuous improvement activities including development of SOPs, standard methodologies, and initiatives within clinical data management.
  • Contribute to project resource planning, vendor evaluation and selection, development of outsourcing strategies and relationships with vendors and partners.
  • Participate in inspection readiness, quality compliance, and training initiatives related to Clinical Data Management.
  • Assist in building and developing team of high performing clinical data managers.

QUALIFICATIONS AND EXPERIENCE:

  • Bachelor's degree: 12+ years of relevant industry experience in Clinical Data Management preferred
  • Experience in providing sponsor oversight for study vendors to ensure completeness, correctness and consistency of clinical data and data structures across programs.
  • Strong knowledge of project management principles and ability to manage multiple competing tasks and fast changing priorities.
  • Advanced knowledge and experience of Data Management processes and systems.
  • Strong knowledge and understanding of industry standards including ICH, GCP, CDASH/CDISC and other applicable guidelines.
  • Experience with regulatory submission requirements [e.g., New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)].

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, one Friday a month paid-time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all lab essential 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.

Keywords: Vir Biotechnology, Inc., San Francisco , Associate Director, Clinical Data Management, Other , San Francisco, California

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