Clinical Data Manager II

Clinical Development United States


Description

 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. 

About the Position

Zymeworks is seeking a Clinical Data Manager (CDM) II to lead Data Management aspects of a clinical study with minimal support and oversight. The CDM II will have working knowledge of FDA regulations and industry standards, strong technical skills, and is capable of supporting infrastructure assessment and improvement. 

This position will be based in US or Canada (Remote) and will report to a Manager, Data Management position or above. 

Key Responsibilities

  • Manages clinical data management project activities performed by vendors/CROs, as appropriate, to ensure delivery on time, within scope, and with quality. 
  • Develops and reviews DM documents, including DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, and data review plans.  
  • Participates in review of additional clinical documents, including protocol, IRT specifications, medical monitoring plan.
  • Ensures resource availability and manages stakeholders. May assist in the selection of vendors (Lab, CRO).  
  • Ability to run SAS programs, reviews SAS logs, and generates output and/or SAS Data Listings as appropriate for SAS skill level.  
  • Leads data cleaning activities such as study team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation.  
  • Ability to prepare for and execute database lock activities successfully.
  • Ensures data management deliverables are met per study timelines by understanding and monitoring critical tasks and milestones of the clinical project.
  • Communicates effectively, utilizing available metrics reports, experience, knowledge, and other resources to 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.   
  • Participates in working groups to develop and implement new processes and applications.  
  • Develops and assists in maintenance of department tools, templates, Standard Operative Procedure and Guideline.
  • Actively fosters an environment of effective and collaboration amongst employees, management and external partners.  

Qualifications and Experience

  • BA or BS in a relevant field and 2-5 years related experience or an equivalent combination of education and experience.
  • Ability to work independently with minimal supervision.
  • Excellent interpersonal skills and the ability to work collaboratively as a member of cross functional team. 
  • Ability to establish and maintain effective and working relationships.  
  • Keen organizational skills and the ability to work effectively in a high paced, fast changing environment focusing on results. 
  • Technologically savvy; ability to learn quickly to and apply new information, standards, regulations, tools, methods or software as it relates to position and profession.
  • Detail oriented, producing high quality accurate work on schedule. 
  • Working knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development.
  • Previous experience with relevant electronic systems as such EDC and IRT.
  • Previous vendor/CRO management experience.
  • SAS programming experience recommended but not required. 

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. 

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