Senior Clinical Data Manager — Hybrid (WA/Dublin)

Zymeworks Inc.; Dublin; Hybrid; EUR 66,000 - 101,000; Full time

Benefits offered by this job

Industry leading vacation and paid时间

Exceptional medical, dental and vision

Job summary

Zymeworks Inc. seeks a senior data management professional to oversee, coordinate, and optimize clinical data for studies across a global portfolio. You will ensure data quality by guiding vendor activities, developing documentation, and leading data cleaning with cross-functional partners.

The role combines regulatory rigor with practical data operations in a hybrid setup. Located in Dublin, IRE or Bellevue, WA, the position supports advancement of oncology and other therapeutic programs, with

Qualifications

• 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 electronic systems as such EDC, IXRS, RTSM. Medidata Rave preferred.
• Previous vendor/CRO oversight experience.
• Preferred: Oncology experience; Experience with ePRO, SharePoint, J-Review, BI tools; Database development; Programming experience.

Responsibilities

• 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 data management documentation (CRFs, Data Management Plans, Edit Check Specifications, etc.).
• Perform DM lifecycle activities from study start-up to close-out, including CRF development and UAT.
• Lead study team in the data cleaning process efficiently and on time.
• Understand milestones to ensure data management deliverables meet study timelines.
• Maintain DM metrics, timelines, agendas/minutes, etc.
• Contribute to continuous improvement of CDM processes and SOPs.
• Manage third-party data and reconciliations.

Skills

FDA regulations & ICH GCP

Data management lifecycle

Vendor oversight

Cross-functional collaboration

Oncology experience

Education

Bachelor's degree in a relevant field

Tools

Medidata Rave

EDC

IXRS

RTSM

SharePoint

J-Review

BI tools

Job description

Zymeworks Inc. seeks a senior data management professional to oversee, coordinate, and optimize clinical data for studies across a global portfolio. You will ensure data quality by guiding vendor activities, developing documentation, and leading data cleaning with cross-functional partners.

The role combines regulatory rigor with practical data operations in a hybrid setup. Located in Dublin, IRE or Bellevue, WA, the position supports advancement of oncology and other therapeutic programs, with