eTMF Document Specialist

Clinical Operations Seattle, Washington United States


Why Work for Us?

Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care

We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

Company Description

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer.  Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.

Zymeworks is seeking a highly-motivated professional who is looking to grow their career with our company. The eTMF Document Specialist is responsible for providing supports to the TMF Manger, Clinical Operations and Service Providers to ensure a complete, accurate and high-quality eTMF, including set up, maintenance and close-out of the eTMF.  Assist effort to ensure the company eTMF is always inspection ready. This position will report to the Manager, Electronic Trial Master File and will be based in either Vancouver, BC or Seattle, WA.

As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such.

Key Responsibilities

  • Support the study team with eTMF set up activities (e.g. TMF Plan & Index review, data/records entry as needed) 
  • Assist with user access process
  • Assist with eTMF documents uploading/filing as needed
  • Participate in the conduct of quality review of the TMF for each assigned study per the time points captured in the study specific TMF Plan. Raise queries for TMF issues found, as applicable
  • Support study teams for resolution of eTMF related queries or quality issues
  • Ensure similar documentation issues are handled consistently across all trials/programs
  • Support eTMF review process by working closely with study teams, CROs and Vendors
  • Provide study teams with relevant reports and outputs to support TMF Quality
  • Support TMF manager with eTMF Close-out activities (e.g. Update TMF Index, generate final eTMF Inventory report)
  • Build collaborative relationships with cross-functional teams
  • Support eTMF operations during eTMF audits and/or regulatory inspections
  • Participate in process improvement initiatives as needed

Qualifications and Education

  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 2 years’ relevant clinical site management and/or pharmaceutical/biotech/CRO experience or an equivalent combination of education and experience.
  • Minimum 1 year of relevant documents and records management, quality content review and comprehensive completeness review experience
  • Knowledge of ALCOA standard, GCP and ICH E6(R2) guidelines
  • Good working knowledge of the TMF Reference Model
  • Experience with electronic document management system(s). Veeva eTMF experience preferred
  • Basic knowledge and understanding of applicable regulations including CFR, ICH/GCPH guidelines and regulatory requirements.
  • Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional team. Ability to establish and maintain effective working relationships.

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.