Senior Director/Director, Data Management
Company: Novavax
Location: Gaithersburg
Posted on: January 14, 2021
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Job Description:
Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology
company that promotes improved health globally through the
discovery, development, and commercialization of innovative
vaccines to prevent serious infectious diseases. Novavax recently
initiated development of NVX-CoV2373, its vaccine candidate against
SARS-CoV-2, the virus that causes COVID-19, and achieved positive
Phase 1 clinical trial results. NanoFlu, its quadrivalent influenza
nanoparticle vaccine, met all primary objectives in its pivotal
Phase 3 clinical trial in older adults. Both vaccine candidates
incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in
order to enhance the immune response and stimulate high levels of
neutralizing antibodies. Novavax is a leading innovator of
recombinant vaccines; its proprietary recombinant technology
platform combines the power and speed of genetic engineering to
efficiently produce highly immunogenic nanoparticles in order to
address urgent global health needs.The Sr. Director / Director of
Data Management is responsible delivery of global data management
strategy and overseeing end to end data management activities and
deliverables of our vendor partners across multiple programs. You
are responsible for leading vendor oversight of clinical data
management in the areas of project management, data systems and
quality, and is accountable for the implementation of data strategy
to ensure outsourced data management activities are performed in
compliance with regulations, according to study protocol, and the
clinical data management plan. You will be the key point person and
primary point of escalation for internal teams of Medical, Clinical
Project Management, Biostatistics and Programming, Project
Management, Quality Assurance, and Regulatory Affairs. This
position will report to the Vice President, Clinical Operations.
Responsibilities include but are not limited to:Leadership of all
data management activities including deliverables for the build,
collection, review, monitoring of clinical data including CRF data,
ePRO, and internal and external laboratory data to ensure that
studies are executed within the agreed timelines and according to
applicable SOPs, global standards, and working practices.
Development and management of a resource plan to ensure Data
Management is able to deliver the business portfolio, including
Data Acquisition, Data Standards & SDTM Delivery and functional
service providers.Accountable for the implementation of data
strategy at a program and study level, monitoring, and timeliness
of data processing performed by the CRO from start up through data
archival including activities related to cleaning, acquisition and
standards, clinical data reporting and analytics, centralized
monitoring, and medical coding to ensure cohesive support to
clinical trial data collection, review, and reporting.Develops
quality oversight and management standards of external partners
(e.g. CROs, technology providers, etc.) who are performing data
management services for Novavax, and leads and manages Sponsor
oversight of data reports, metrics, and key performance indicators
(KPIs) to monitor vendor performance and proactively provides risk
and mitigation feedback directly to vendor. Drives functional line
RFP assessment, budget review, and invoice approval standard
practices. Line management, coach, and support data management
staff. Identify, lead and drive process improvements within the DM
community.Reviews the Data Management Plan (and other data related
plans, risk registers, and documents) to ensure consistency within
a program, oversees interim and final cleaned database freeze and
release strategy and timeliness; and regulatory submission related
activities. Foster relationship with Medical, Biostatistics, and
Programming teams understand data delivery for business needs and
priorities.Point of escalation for all data management study
issues. Other duties as assigned.Minimum Requirements:Bachelor's
degree minimum requirement and 12 years of relevant data management
experience in biotechnology, pharmaceutical or CRO settings. Global
clinical trial and vaccine therapeutic experience highly
desiredProficient experience using commercial clinical data
management systems and/or EDC products (e.g. RAVE EDC). Proficient
with implementation and data transfer of external data to clinical
database (e.g., external laboratory and Electronic Patient Reported
Outcomes (ePRO) data and eSource).Data visualization tools (e.g.
Spotfire, J-Review) and MedDRA/WHO-Drug coding expert.Proficiency
in SQL and scripting with experience in developing advanced
queries, stored procedures and views. SAS programming is a plus.
Proficient in development and maintenance of the Data Management
Plan, data review and query management, data access and
visualization, metrics reporting, external data transfer into
clinical database, and database release activities. Experienced
with data reconciliations between clinical database and other
databases (e.g. Product Safety and LIMS)Solid understanding of
statistical outputs (tables, listings and graphs) to ensure data
review reports match program and study needs.Understanding of
regulatory requirements for license applications with US FDA and
other regulatory agenciesFluent with CDISC requirements including
CDASH, SDTM, and ADAM.Additional Qualifications / Experience
Preferred:Interface with external vendors developing
systems/applications for clinical trial data collection (e.g.
ePRO/eCOA) to ensure quality and timely deployment.Experience in
developing the tools/reports to support CRO oversight
activities.Demonstrates strong verbal and written communication
skills including ability to communicate remotely.Detail oriented,
ability to multi-task with strong prioritization, planning and
organization skills Good written and spoken EnglishWillingness to
travel for job related activities if required (expected travel for
this position is
Keywords: Novavax, Washington DC , Senior Director/Director, Data Management, Executive , Gaithersburg, DC
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