Clinical Trials Associate (12-month contract)

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.

About the role

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).
Absorb 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.
Collaborate with cross-functional teams and external vendor to review patient data.
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.

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).
• Absorb 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.
• Collaborate with cross-functional teams and external vendor to review patient data.
• 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.

Requirements

• 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.
• 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.

Qualifications

• 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.
• 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.

Skills

• 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.

Benefits

Total Rewards

• Competitive salaries
• Generous benefits
• An outstanding work environment
• Excellent opportunities for professional growth

Pay

The Pay Range For This Role Is31,500 - 48,300 EUR per year (IE)56,250 - 86,250 USD per year (US)