Clinical Data Manager (6-month contract)

Zymeworks Inc. • Bellevue, WA

17h

About The Position

What You'll Do
Oversees/participates in clinical data management project activities performed by vendors/CROs to ensure activities are performed with the highest quality.
Represents Zymeworks on cross-functional teams for assigned studies.
Contributes 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.
Performs 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.
Leads study team in the data cleaning process in an efficient and timely matter.
Understands critical tasks and milestones to ensure data management deliverables are met per study timelines.
Maintains DM metrics, timelines, meeting agendas/minutes, etc.
Contributes to the continuous improvement of CDM processes, including development/updating of SOPs and Work Instructions.
Management of third-party data and corresponding reconciliations.

Requirements

• 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.
• 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.

Nice To Haves

• Oncology experience
• Previous experience with ePRO, SharePoint, J-Review, Business Intelligence tool
• Database development experience
• Programming experience

Responsibilities

• Oversees/participates in clinical data management project activities performed by vendors/CROs to ensure activities are performed with the highest quality.
• Represents Zymeworks on cross-functional teams for assigned studies.
• Contributes 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.
• Performs 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.
• Leads study team in the data cleaning process in an efficient and timely matter.
• Understands critical tasks and milestones to ensure data management deliverables are met per study timelines.
• Maintains DM metrics, timelines, meeting agendas/minutes, etc.
• Contributes to the continuous improvement of CDM processes, including development/updating of SOPs and Work Instructions.
• Management of third-party data and corresponding reconciliations.

Benefits

• Industry leading vacation and paid time off
• Exceptional medical, dental and vision benefits by country
• Zymelife health and wellness benefits
• Matching RRSP / 401K / Pension program
• Employee Share Purchase Program
• Employee Equity Program
• Paid time off to volunteer in your community

What This Job Offers

• Career Level: Mid Level