Senior Clinical Data Manager

Seattle, United States

Zymeworks

Posted on: October 16, 2020

Closing: November 15, 2020

Salary: Undisclosed

Position Type: Full Time

Job 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 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 report to the Senior Manager, Data Management or above and will be based in Seattle, WA or Vancouver, BC.

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, 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 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 CDAs, as needed; assists in mentoring junior CDAs and/or contractors.
  • 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 cross functional team. Ability to establish and maintain effective and 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 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 experience
  • SAS programming experience

Preferred:

  • Previous experience with ePRO, SharePoint, JReview, Business Intelligence tool
  • Database development experience

Why work for us?

Innovation. Act with Integrity. Collaboration. 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.

Zymeworks

Posted on: October 16, 2020

Closing: November 15, 2020

Salary($): Undisclosed

Position Type: Full Time

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