Clinical Trials Associate

Company Description

Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. The Company’s asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the early-stage development of innovative medicines.We are a global company headquartered in Vancouver BC, with operations in Bellevue WA, Dublin IRE, and Singapore.

Why Work With Us

Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

This role will be located in Dublin, IRE OR Bellevue, WA and is hybrid with a minimum of 3 days per week onsite. This is a 12-month fixed term position.

What You'll Do

• Provide administrative support to clinical trial teams.
• Assist in the preparation and maintenance of essential trial documents.
• Organize internal study team meetings and issue agendas/minutes (with approval from CTM).
• Assist and support eTMF Manager in QC of eTMF.
• Set up and ensure all study-related documents are filed per folder structure on internal filing repository (Sharepoint).
• Assist CTM in keeping internal study conduct tracker, and any other oversight trackers up-to-date.
• Maintain study conduct metrics, including but not limited to study start up timelines, enrollment rates, screen-failure rates and deviation rates.
• Monitoring review oversight of external vendor.
• Patient data review in collaboration with cross-functional teams and external vendor.
• Assist in reviewing invoices, including pass-throughs, referring to site agreements, patient enrollment and/or monitoring visit trackers.
• Carry out the function of the role in compliance with company Standard Operating Procedures (SOPs), working practices and regulatory guidelines.
• Foster effective and collaborative working relationships with cross-functional teams and management globally to ensure trial milestones are met.
• Promote timely and accurate communication amongst the internal and external teams.
• Serves as back-up to the CTM, when needed.

What You'll Bring

• Bachelor’s degree preferably in the field of biology, chemistry or health sciences and 1-3 years’ previous clinical research experience.
• Prior Clinical Trials Associate experience in oncology preferred.
• Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional and global team. Ability to establish and maintain effective working relationships.
• Good organizational skills and the ability to work effectively in a high paced, fast changing, compliance-driven environment. Results-oriented and flexible attitude.
• Ability to track and manage key dates/deadlines.
• Basic knowledge of drug development and FDA GCP regulatory guidelines.
• Familiarity with FDA/ICH regulatory requirements for clinical trials is desired.
• Excellent oral and written communication skills, with particular attention to detail.
• Ability to appropriately handle confidential information.
• Proficiency with MS Office and Excel.

Total Rewards

We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.

The base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is được posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).

Our total rewards package that includes: * Industry leading vacation and paid time off * Exceptional medical, dental and vision benefits by country

This role is not eligible for relocation or immigration support.

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.

NOTE TO AGENCIES: Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.