Clinical Trials Associate (12-month contract)

Zymeworks Inc.

13d•€31,500 - €48,300

About The Position

This role provides essential administrative support to clinical trial teams, ensuring the smooth operation and documentation of clinical studies. The Clinical Trials Associate will assist in preparing and maintaining critical trial documents, organizing meetings, and supporting the electronic Trial Master File (eTMF) system. The position involves maintaining study conduct trackers, monitoring metrics, and overseeing external vendors. Collaboration with cross-functional teams and adherence to regulatory guidelines are key aspects of this role. The associate will also assist with invoice reviews and serve as a backup to the Clinical Trial Manager (CTM) when necessary.

Requirements

Bachelor’s degree preferably in the field of biology, chemistry or health sciences
1-3 years’ previous clinical research experience.
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.
Excellent oral and written communication skills, with particular attention to detail.
Ability to appropriately handle confidential information.
Proficiency with MS Office and Excel.

Nice To Haves

Prior Clinical Trials Associate experience in oncology preferred.
Familiarity with FDA/ICH regulatory requirements for clinical trials is desired.

Responsibilities

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.