• 28-May-2021 to 28-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 Trial Master File (TMF) Specialist to work in our Gaithersburg, MD Clinical Operations Department.

The Senior Trial Master File Specialist is responsible for the oversight, management, and quality of clinical trial content, with a strong focus on oversight of the set up and routine documentation filing of the TMF to ensure adherence with the TMF Plan, SOPs, and ICH/GCP/regulatory guidelines. This position plays a key role in both paper and electronic TMF system management and coordinating content management activities performed by third parties, such as CROs, as well as other internal and external team members as required. This position will report to Manager, Trial Master File.

Responsibilities include but are not limited to:

  • Overall management and quality maintenance of essential clinical trial documents and other designated content, including the set up and maintenance of the TMF, with a strong focus on ensuring that routine document management operations are performed with adherence with SOPs and ICH/GCP/regulatory guidelines
  • Oversight and assistance with the overall TMF completion, including appropriate content filing and maintenance, cross-functional document coordination, including third party content
  • Reviews TMF Plans and timelines; interact with CRO partners to oversee their TMF activities and review and provide feedback on performance metrics
  • Conducts and documents TMF/eTMF content reviews for quality, completeness, and other performance metrics on a regular basis to support inspection readiness
  • Maintain metadata and indexing, processing, publishing, records retention best practices
  • Work with internal functional groups to facilitate, train, and review filing of TMF content
  • Manages activities for off-site archival of TMF content
  • Provides input to Novavax TMF strategy including internal TMF SOPs or work instructions governing studies using an outsourcing model
  • Manage and organize the clinical operations and TMF content within the network file share drive
  • Verifies receipt, reviews for identification and consistency, sorts, separates, photocopies, prints, scans, indexes, labels, and files a variety of clinical, regulatory, and other non-clinical documents, as assigned
  • Files content into electronic Trial Master File (eTMF) management systems such as Veeva Vault eTMF
  • Other duties as assigned

Minimum requirements:

  • Bachelor's degree, preferably in a scientific discipline
  • 3 5 years or more of experience with eTMF management systems, solutions, practices, workflows
  • Working knowledge of Good Documentation Practices (GDP), Good Clinical Practices (GCP) and TMF best practices, such as the DIA Reference Model
  • Capable of working with multiple IT systems, including Electronic Document Management Systems
  • Experience with coordinating document management activities performed by internal teams and third parties, such as clinical vendors
  • Ability to manage multiple projects and effectively prioritize activity
  • Knowledge of clinical research concepts and able to work in a team environment
  • Excellent organizational and planning skills
  • Ability to build and maintain positive relationships with management and peers
  • Excellent written and verbal skills required
  • Good written and spoken English
  • Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook, Project

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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