Clinical Trials Manager (12-month contract)

Zymeworks Inc.•Vancouver, BC

11d•CA$91,500 - CA$140,300•Onsite

About The Position

This role is responsible for managing clinical trials, acting as the clinical trial lead on early-phase studies, and ensuring compliance with global study timelines and corporate goals. The position involves developing and implementing study-specific processes, managing study teams, and collaborating with various stakeholders to ensure the successful execution of clinical trials. The role also includes vendor and site management, as well as leadership in clinical trial operations.

Requirements

University degree and relevant clinical trials experience in pharmaceutical, biotech or CRO setting including clinical trial management experience.
Minimum of 5 years’ pharmaceutical industry drug safety experience, optimally in a small-to-mid cap biotech environment.
An equivalent combination of education and experience may be considered.
Prior experience in lead role of global clinical trials is required.
CRO/vendor management and oversight experience are required.
Knowledge of and experience with international regulatory adverse event reporting requirements.
Demonstrated line management experience.
Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.
Thorough knowledge of FDA/EMA, CFR and GCP/ICH requirements.
Ability to work independently, establish functional priorities and execute on goals.

Nice To Haves

Oncology clinical research experience is preferred.
Experience in oncology drug development desirable.

Responsibilities

Acts as clinical trial lead on one or two early-phase clinical studies
Maintains global study timelines and aligns study start-up, enrollment, study conduct and close out activities with corporate goals.
Identifies and ensures compliance with Key Performance Indicator (KPI); Key Risk indicators (KRI); and Key quality indicators (KQI) for assigned clinical trial.
Ensures study is carried out according to the study protocol, SOPs, CFR, ICH/GCP guidelines and study-specific manuals and procedures; collaborates with QA to ensure inspection readiness.
Develops and implements study specific processes and trains study teams.
Works closely with the study management team to develop clinical trial protocols and designs all associated clinical forms, including Case Report Forms, SAE Forms, etc. for assigned clinical trial.
Prepares, reviews, and approves study-related documents (e.g., Monitoring plans, Laboratory Manual, Patient Diary and CRF completion guidelines).
Proactively identifies study issues/risks and recommends/implements solutions for assigned clinical trial.
Reviews and analyzes clinical trial data routinely to identify, develop and implement changes required for improvement and compliance at site level and/or study level.
Develops and reviews site budgets working closely with finance and CRO partner.
Plans and conducts, investigator meetings, internal team meetings, and other trial-specific meetings.
Assists in the preparation and follow-up of in-house and on-site quality audits, as well as regulatory authority inspections.
Collaborates with CRO to manage site related interactions and serves as a liaison and resource for investigational sites. Troubleshoots and helps to address recruitment obstacles.
Reviews CRO/vendor invoices for accuracy.
Reviews and analyzes the initial and revised scope of service agreements, budgets, plans, and detailed timelines ensuring that performance expectations (timeline/quality/cost) are met with the CRO/vendor.
Manages assigned clinical trial with minimal oversight.
Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
Develops and implements processes with efficiencies for assigned clinical study
Fosters effective and collaborative working relationships with fellow employees, management, and external partners.
Other related duties as required.