Senior Clinical Data Manager

Clinical Research Seattle, Washington United States


Why Work for Us?

Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care

We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

Company Description

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer.  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.

Zymeworks is seeking a Senior Clinical Data Manager (CDM) to lead Data Management aspects of a clinical study with minimal support and oversight. The Sr CDM 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 (US), Vancouver (CA) or remote and will report to the Manager, Data Management or above.

As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such.

Key Responsibilities

  • Manages clinical data management project activities performed by vendors/CROs, as appropriate, to ensure delivery on time, within scope, and with quality.
  • Independently develops and reviews relevant data management documents, including data management plans, case report form (CRF), CRF completion guidelines, edit checks, UAT specifications, IRT- EDC Integration specification, project data flow and integrity plans, blinding plans, and clinical data review plans.
  • Participates in review of additional clinical documents, such as protocol, IRT specifications and medical monitoring plan.
  • Ensures resource availability and manages stakeholders. May assist in the selection of vendors (Lab, CRO).
  • Programs non-system edit check (NSECs, data listings as appropriate), runs SAS programs, reviews SAS logs, and generates output and/or SAS Data Listings as appropriate for SAS skill level.
  • Independently leads data cleaning activities Including Study Team data reviews, NSEC 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 of the clinical project; ensures data management deliverables are met per study timelines.
  • Effectively communicates and utilizes available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all project data management activities.
  • Ensures study team members from different functional areas understand and deliver components affecting data to ensure successful execution of project 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.
  • Participates in working groups to develop and implement new processes and applications.
  • Coordinates and delegates work performed by junior CDMs, as needed; assists in mentoring junior CDMs and/or contractors. Zymeworks Inc. 540-1385 West 8th Ave, Vancouver, BC, Canada, V6H 3V9
  • Utilizes experience and leadership skills to provide guidance to other team members.
  • Actively works to foster an environment of effective and collaborative working relationships amongst employees, management, and external partners.

Qualifications and Education

  • BA or BS in a relevant field and a minimum of 5 years’ related experience or an equivalent combination of education and experience
  • Proven interpersonal skills and the ability to work collaboratively as a member of a 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. Results oriented
  • Technologically savvy; ability to quickly learn and implement the latest 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 such as EDC, IXRS, RTSM
  • Previous vendor/CRO management experience • SAS programming experience


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

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.