Clinical Trial Manager
Clinical Trial Manager
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation 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.
- Manage defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, in compliance with SOPs FDA regulations, and ICH/GCP guidelines.
- Develop strong working relationships and maintain effective communication with all functional groups.
- Act as a clinical trial lead, assist in identification of optimal CROs, and manage CROs and other study vendors.
- Work closely with study sites staff and field-based site CRAs.
- Review monitoring reports and monitoring visit letters.
- Develop or assist in preparation of supportive study supplies and documents (e.g., lab manuals, lab kits, site study tools, pharmacy manuals).
- Work proactively with data management vendor to review metrics and follow up with clinical CRO for data currency.
- Perform sponsor oversight co-monitoring visits.
- Perform on-going review of the TMF to ensure files are properly maintained and archived.
- Analyze and report safety issues, patient care issues and study conduct issues.
- Work closely with finance group to review vendor invoices and approve payments.
Education and Experience
Bachelor’s degree in scientific disciple required, MS or equivalent preferred. 5+ years pharma/CRO industry experience in oncology drug development, hematology trials and 2+ years on-site monitoring experience. Global trial and CRO management preferred. Previous experience with database build preferred.
Skills and Abilities
- Strong knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures.
- Strong organizational and motivational skills, with an exceptional attention to detail.
- Good analytical and assessment skills, judgement, and problem solving skills.
- Ability to travel for site co-monitoring activities, vendor visits/audits as required (up to 30%).
- Oncology background required.
Why Work for Us?
Zymeworks’ employees are passionate, engaged and extremely motivated to succeed. We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big. To learn more about Zymeworks Inc. and our current openings, please visit our website at www.zymeworks.com.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
How to Apply
If you are interested in this challenging and rewarding position, please email your resume and cover letter to firstname.lastname@example.org with “Clinical Trial Manager” in the subject line.