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
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
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
- Lead continuous improvement activities including development of
SOPs, standard methodologies, and initiatives within clinical data
- 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
- Advanced knowledge and experience of Data Management processes
- Strong knowledge and understanding of industry standards
including ICH, GCP, CDASH/CDISC and other applicable
- 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
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
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.