Clinical Trials Manager
Clinical Trials Manager
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics. 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.
Zymeworks is seeking a highly motivated professional who is looking to grow their career with our company. This position will be based in Seattle and will report to the Clinical Program Manager.
- Ensures studies are carried out according to the study protocol, SOPs and ICH/GCP regulations and study-specific manuals and procedures; collaborates with clinical program manager to ensure inspection readiness.
- Acts as a clinical trial lead and works closely with the Clinical Program Manager to manage the clinical trial, with the ability to identify issues and adapts to changes.
- Assists with CRA and third-party vendor training on protocol and practices.
- Develops and maintains good working relationship with investigators and study staff.
- Identifies, selects and monitors performance of investigational sites for clinical studies in collaboration with CRO partners.
- Contributes in the identification of optimal CROs and manages CROs and other study vendors.
- Oversees performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to clinical program manager.
- Undertakes ongoing collaboration to ensure CRF design and guidelines meet study requirements.
- Reviews monitoring reports and monitoring visit letters to provide sponsor feedback and approval as needed.
- Develops or assists in preparation of supportive study supplies and documents (e.g., lab manuals, lab kits, site study tools, pharmacy manuals).
- Tracks and reports on progress of study including site activation, patient enrollment, monitoring visits.
- Plans and conducts investigator meetings.
- Oversees/performs sponsor oversight, co-monitoring visits on a regular basis.
- Analyzes and reports safety issues, patient care issues and study conduct issues as escalated by clinical CRO.
- Contributes to development of site budget working closely with Clinical Program Manager.
- Fosters effective and collaborative working relationships with fellow employees, management and external partners.
Qualifications and Experience
- Bachelor’s degree in scientific discipline required and a minimum of 5 to 7 years’ (at least 2 years management) related experience in oncology drug development, hematology trials and on-site monitoring or an equivalent combination of education and experience
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships
- Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment
- Strong knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
- Experience in managing external CRO resources performing early phase clinical oncology trials
- Good analytical and assessment skills, judgement and problem-solving skills
- Exceptional attention to detail
- Proficiency with MS Office
- Previous experience with database build, an asset
- Ability to travel for site co-monitoring activities, vendor visits/audits as required (up to 30%)
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 http://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 opportunity, please forward your cover letter and resume to firstname.lastname@example.org.