This role can be located in Bellevue, WA or Dublin, IRE and is hybrid with a minimum of 3 days per week onsite.
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 team 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.
Total RewardsWe offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.
The base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate's location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).
Our total rewards package that includes:
- Industry leading vacation and paid time off
- Exceptional medical, dental and vision benefits by country
This role is not eligible for relocation or immigration support.
NOTE TO AGENCIES: Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.
The pay range for this role is:
66,000 - 101,200 EUR per year (IE)
101,250 - 155,250 USD per year (US)
