Clinical Data Manager

Company Description
Zymeworks is a publicly listed (NASDAQ:ZYME) R&D and clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, bispecific and 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. We are  a global company headquartered in Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and Redwood City, CA. 

Why Work With Us

Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

This position is open to qualified candidates in our San Francisco hub (Redwood City) and is eligible for our Hybrid Work Plan (3 days per week in office).  The role will report to the Director, Data Management.

How You'll Contribute

Zymeworks is seeking a Clinical Data Manager to contribute to Clinical Data Management activities. This role will complete data management tasks with a high degree of quality in accordance with regulatory requirements and Zymeworks’ timelines. The Clinical Data Manager will have a thorough knowledge of FDA regulations and industry standards, strong technical skills, and capable of working independently and collaboratively, in addition to providing oversight of CRO activities. 

What You'll Do

• Oversee/participate in clinical data management project activities performed by vendors/CROs to ensure activities are performed with the highest quality.
• Represent Zymeworks on cross-functional teams for assigned studies.
• Contribute to the development/review of relevant data management documentation, including but not limited to CRFs, CRF Completion Guidelines, Data Management Plans, Edit Check Specifications, Data Review Plans, Data Transfer Specifications, etc. 
• Perform DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Activities include, but are not limited to, CRF development, edit check specifications development, User Acceptance Testing, query management, etc.
• Lead study teams in the data cleaning process in an efficient and timely matter.
• Understand critical tasks and milestones to ensure data management deliverables are met per study timelines.
• Maintain DM metrics, timelines, meeting agendas/minutes, etc.
• Contribute to the continuous improvement of CDM processes, including development/updating of SOPs and Work Instructions.
• Manage third-party data and corresponding reconciliations.

What You'll Bring

• BA or BS in a relevant field and a minimum of 8 years related experience or an equivalent combination of education and experience.
• Thorough knowledge of FDA regulations, ICH GCP guidelines, Good Clinical Data Management Practices, SDTM, CDISC, database development, user acceptance testing, medical coding, the drug development process.
• Previous relevant electronic systems as such EDC, IXRS, RTSM. Medidata Rave preferred.
• Previous vendor/CRO oversight experience.
• Preferred: 
• • Oncology experience
  • Previous experience with ePRO, SharePoint, J-Review, Business Intelligence tool
  • Database development experience
  • Programming experience
• Proven interpersonal skills and the ability to work collaboratively as a member of cross functional team.  Ability to establish and maintain effective working relationships.
• Effective organizational skills and the ability to work effectively in a high paced, fast changing environment.
• Ability to multi-task and prioritize.
• Detail oriented; performs quality and accurate work.
• Technologically savvy; ability to quickly learn and implement new information, standards, regulations, tools, methods, or software as it relates to position and profession.