Clinical Trial Associate/Senior Clinical Trial Associate

Location
Vancouver, British Columbia (CA)
Salary
Commensurate with experience
Posted
Jun 01, 2017
Closes
Jul 25, 2017
Hours
Full Time

                        

Clinical Trial Associate/Senior Clinical Trial Associate

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.

Key Responsibilities

  • Development and editing of study-related materials.
  • Planning and coordination of information at Investigators’ meetings.
  • Providing support to the clinical sites and clinical team during the conduct of the clinical trials.
  • Management and tracking of study projects through CTMS or other electronic means.
  • Management of investigational drug and study supplies by preparing and ensuring the accuracy of shipments of study-related materials.
  • Flow of data including facilitating CRF retrieval and query resolution.
  • The collection, review and filing of regulatory and other documents such as site reports and FDA 1572 forms.
  • Set up, review and maintenance of eTMF.
  • Support clinical team with review of vendor invoices and investigator payments.

Education and Experience

Bachelor’s degree or equivalent and a minimum of 5 years of clinical research experience in a pharmaceutical/biotech or CRO setting is desired.

Skills and Abilities

  • Experience in interactions with outside CROs and other vendors.
  • Knowledge and understanding of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.
  • Experience providing clinical operations expertise to clinical development in a specified project or project area.
  • Working knowledge and experience with electronic data capture (EDC) systems and CTMS.
  • Experience in setting up CTMS and eTMF systems is a plus.

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 careers@zymeworks.com with “Clinical Trial Associate/Senior Clinical Trial Associate” in the subject line.