Clinical Data Manager (12-month contract)

Zymeworks Inc.

1d•€66,000 - €101,200

About The Position

The Clinical Data Manager oversees and participates in clinical data management activities performed by vendors and CROs, ensuring high-quality work. The role represents Zymeworks on cross-functional study teams and contributes to developing and reviewing data management documentation, including CRFs, CRF Completion Guidelines, Data Management Plans, Edit Check Specifications, Data Review Plans, and Data Transfer Specifications. The position performs data management activities throughout the study lifecycle, from start-up and maintenance through database lock and close-out. Activities include CRF and edit-check specification development, User Acceptance Testing, query management, leading efficient and timely data cleaning, monitoring deliverables against study timelines, and maintaining data management metrics, timelines, agendas, and meeting minutes. The role also manages third-party data and reconciliations and contributes to continuous improvement of clinical data management processes, including SOPs and Work Instructions. This is a 12-month contract. Zymeworks describes its total rewards package as including competitive salaries, generous benefits, an outstanding work environment, and opportunities for professional growth. The role is not eligible for relocation or immigration support.

Requirements

BA or BS in a relevant field and a minimum of 8 years of 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, and the drug development process.
Experience with relevant electronic systems such as EDC, IXRS, and RTSM.
Previous vendor/CRO oversight experience.
Proven interpersonal skills and ability to collaborate as a member of a cross-functional team and establish and maintain effective working relationships.
Effective organizational skills and ability to work in a fast-paced, changing environment.
Ability to multitask and prioritize.
Attention to detail and ability to produce accurate, high-quality work.
Technological aptitude and ability to quickly learn and implement new information, standards, regulations, tools, methods, or software related to the position and profession.

Nice To Haves

Medidata Rave experience.
Oncology experience.
Experience with ePRO, SharePoint, J-Review, or a Business Intelligence tool.
Database development experience.
Programming experience.

Responsibilities

Oversee or participate in clinical data management project activities performed by vendors and CROs to ensure high-quality work.
Represent Zymeworks on cross-functional teams for assigned studies.
Contribute to the development and review of data management documentation, including CRFs, CRF Completion Guidelines, Data Management Plans, Edit Check Specifications, Data Review Plans, and Data Transfer Specifications.
Perform data management lifecycle activities from study start-up and maintenance through database lock and close-out, including CRF development, edit-check specification development, User Acceptance Testing, and query management.
Lead the study team in the data cleaning process efficiently and on time.
Understand critical tasks and milestones and ensure data management deliverables are met according to study timelines.
Maintain data management metrics, timelines, meeting agendas, and minutes.
Contribute to continuous improvement of clinical data management processes, including developing and updating SOPs and Work Instructions.
Manage third-party data and corresponding reconciliations.