Senior Clinical Data Associate
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics. 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.
About the Position
Zymeworks is seeking a CDA to lead Data Management aspects of a clinical study with minimal support and oversight. The CDA will have thorough knowledge of FDA regulations and industry standards, strong technical skills, and is capable of leading infrastructure assessment and improvement. This position will be based in Seattle and will report to the Senior Manager, Data Management.
- Independently develops/reviews DM documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, data flow and integrity plans, blinding plans, and data review plans.
- Manages/coordinates work performed by vendors/CROs as appropriate to ensure quality of product.
- May assist in the selection of vendors (Lab, CRO).
- Programs non-system edit check (NSECs, data listings as appropriate), run SAS programs, review SAS logs, and generate output and/or SAS Data Listings as appropriate for SAS skill level.
- Independently leads data cleaning activities such as but not limited to Study Team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation.
- Independently manages the database lock process in an efficient and timely manner;
- Understands critical tasks and milestones; ensures data management deliverables are met per study timelines.
- Utilizes communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities.
- Ensures study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables.
- Provides solutions for data management issues that arise during study conduct.
- Performs medical coding utilizing MedDRA and WHO-DRUG, as appropriate.
- Evaluates CDM processes and applications for improvements.
- Participate in working groups to develop and implement new processes and applications.
- Coordinates and delegates work performed by junior CDAs, as needed; assists in mentoring junior CDAs and/or contractors.
- Utilizes experience and leadership skills to provide guidance to other team members.
- Fosters effective and collaborative working relationships with fellow employees, management and external partners.
Qualifications and Experience
- BA or BS in a relevant field and a minimum of 5 years’ related experience or an equivalent combination of education and experience
- Effective organizational skills and the ability to work effectively in a high paced, fast changing environment
- Ability to work collaboratively as a member of cross functional team. Ability to establish and maintain effective and working relationships
- Technologically savvy; ability to quickly learn and implement new information, standards, regulations, tools, methods or software as it relates to position and profession
- Detail oriented; performs quality and accurate work
- Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process
- Previous relevant electronic systems as such EDC, IXRS, RTSM
- Previous vendor/CRO management
- SAS programming experience
- Previous experience with EPRO, SharePoint, JReview, Business Intelligence tool
- Database development experience
Why Work for Us?
Zymeworks’ employees are passionate, engaged and extremely motivated to succeed. We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big. To learn more about Zymeworks Inc. and our current openings, please visit our website at www.zymeworks.com.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.