Novavax
  • 26-May-2021 to 25-Jun-2021 (EST)
  • Clinical Development
  • Gaithersburg, MD, USA
  • Full Time - Exempt

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

We are seeking a Senior Manager, Data Management, Coding Specialist to work in our Clinical Development Department with an initial 6-month contract with a possible conversion to fulltime (contract to permanent). This position can be remote.

The Senior Manager of Data Management, Coding Specialist is responsible for leading and managing end to end data management activities and deliverables of our vendor partners across multiple studies. You are responsible for vendor oversight to ensure outsourced data management activities are performed in compliance with regulations, according to study protocol, and the clinical data management plan. Serves as Subject Matter Experts (SMEs) for data management from protocol review to database lock and is primary contact with internal teams of Medical, Clinical Operations, Biostatistics and Programming, Project Management, Quality Assurance, and Regulatory Affairs.

Responsibilities include but are not limited to:

  • Leads oversight 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.
  • Coding Specialist perform oversight of outsourced MedDRA and WHODrug dictionary coding activities to ensure quality and productivity are within established standards. Function as dictionary subject matter expert (SME) to provide guidance for all dictionary related issues and strategies Provide support to activities delivering implementation or integration of dictionary or data management systems using industry standard methodologies
  • Responsible for the strategy, monitoring, and timeliness of data cleaning process 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.
  • Ensures effective quality oversight and management of external partners (e.g. CROs, technology providers, etc.) performing data management services for Novavax. Supports Sponsor oversight by developing reports and applying metrics and key performance indicators (KPIs) to monitor vendor performance and proactively provides risk and mitigation feedback directly to vendor. Participates in study level RFP assessment, and budget review and invoice approval.
  • Lead the development of the data management data review strategy, ensures the creation of robust study-specific data review specifications and aggregating data review. Participates in cross-functional data review meetings and activities in support of key reporting events or database lock plan.
  • Approves and manages the Data Management Plan (and associated documents), edit check, data review and query management, data access and visualization, data cleaning and coding, metrics reporting, drives interim and final cleaned database freeze and release strategy, and regulatory submission related activities.
  • Coordinate with internal Medical, Biostatistics, and Programming team to understand and drive data delivery for business needs and priorities.
  • Ensure operational excellence of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, metrics reporting, and regulatory submission related activities.
  • Provide input to the study risk registers for all data management, eSource, and ePRO risks. Point of escalation for all data management study issues.
  • Other duties as assigned.

Minimum requirements:

  • Bachelor's degree minimum requirement and 8+ years of relevant data management experience in biotechnology, pharmaceutical or CRO settings
  • Have at least 2-3 years' experience in the medical device, pharmaceutical, or biotech industry with emphasis in coding clinical data with standard dictionaries (e.g., MedDRA, WHO-DD)
  • Proficient experience using commercial clinical data management systems and/or EDC products (e.g. RAVE EDC)
  • Experience with implementation and data transfer of external data to clinical database (e.g., external laboratory and Electronic Patient Reported Outcomes (ePRO) data and eSource)
  • Experience using data visualization tools (e.g. Spotfire, J-Review)
  • 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
  • Understanding of data reconciliations between clinical database and other databases (e.g. Product Safety and LIMS)
  • 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 agencies
  • Understanding of CDISC standards including CDASH, SDTM, and ADAM

Additional preferred qualifications:

  • Global clinical trial expertise and prior therapeutic experience in vaccines studies
  • 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 oral communication skills
  • Willingness to travel for job related activities if required (expected travel for this position is < 10%)

Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

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