TMF Specialist/Manager

Location
South San Francisco, CA
Posted
Jan 14, 2022
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

About Us:

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration.

Vaxart has demonstrated that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immuno-oncology indication.

Our mission is the promotion of global health through the development of effective vaccines that can be administered by tablet rather than by injection, providing for the simple and efficient distribution and administration of safe vaccines in any setting.

We are looking for a TMF Specialist/Manager to join our growing South San Francisco team!

Summary:

Vaxart is seeking a self-motivated, and experienced individual to be responsible for working with the clinical team on multiple ongoing and upcoming phase I and phase II clinical trials. The individual supports management of the eTMF systems (in Veeva) by reviewing/conducting quality checks of eTMF’s and TMF documentation across the portfolio. This role also manages filing and maintenance activities for clinical trials during the study start-up, maintenance, and close-out periods. A successful candidate must be detail-oriented with a flexible and solution-oriented outlook with the ability to support team members within Clinical and with our CRO partners.

Responsibilities:

  • Generation and maintenance of study trackers in support of ongoing clinical trials.
  • Maintains effective communication with clinical study teams, CRO staff, and eTMF vendor personnel throughout study start-up, maintenance, and close-out.
  • Supports TMF document filing into Veeva eTMF system.
  • Maintains a naming and filing guide specific to TMF documents (TMF Reference Model).
  • Performs routine quality checks of documents uploaded into the eTMF.
  • Responds to inquiries regarding TMF management and contents.
  • Attends departmental and study-specific meetings and discussions, as required.
  • Runs routine eTMF reports and monitors TMFs for completeness and trends.
  • Performs general document control tasks to support the clinical department.

Requirements:

  • Life sciences degree or certification in a related allied health profession from an accredited institution (e.g., nursing, medical or laboratory technology) or equivalent.
  • 5+ years’ experience in pharmaceutical development and/or clinical trials and eTMF document management experience.
  • Clear and timely communication skills.
  • Proficiency with clinical research documents, their contents, and purpose, and working knowledge of GCP and regulatory requirements.
  • Strong organizational/prioritization skills for the management of workload.
  • Strong attention to detail is a must.
  • Demonstrated proficiency with eTMF applications (Veeva Vault Clinical eTMF experience a plus), word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and Box).
  • Availability to work for at least 20 hours/week.

Vaccination Requirement:

Vaxart has implemented a mandatory COVID-19 vaccination policy which requires our employees to be fully vaccinated against COVID as a condition of employment. Vaxart will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. Vaxart prioritizes sound science and available facts to best ensure the ongoing safety of our employees and the community.

Vaxart offers team members a competitive compensation and benefits package, including a robust health plan, bonus program, stock options, 401K with employer matching, tuition assistance, and work-life balance.

Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, and layoff or termination. Vaxart does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by federal, state or local law, ordinance or regulation.