Senior Clinical Data Coder

Clinical Development Vancouver, BC Canada


Description

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 Coder to support coding activities with minimal support and oversight. The Coder 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 Seattle (US), Vancouver (CA) based or may consider fully remote and will report to a Manager, Data Management.

 Key Responsibilities

  • Performs clinical data coding using MedDRA and WHO Drug coding tools for information contained in certain Case Report Forms (CRF) such as adverse event, medical history, pre-existing conditions, and concomitant medications.
  • Performs review of MedDRA and WHODrug synonym lists, updating them as required to ensure successful study set-up and dictionary up versioning activities.
  • Assists various functions by providing standardized and customized MedDRA queries and standardized and customized drug groupings.
  • Identifies requirements for capturing and processing of clinical data coding ensuring accuracy, consistency and completeness.
  • Performs a comprehensive review of all reported and coded terms in collaboration with Medical Monitors and Global Patient Safety groups.
  • Ensures that the code selections reflect the term provided by the clinical site.
  • Manages queries related to coding terms, through closure, including entering queries into the EDC.
  • Reviews and triages comments with medical monitor.
  • Communicates with lead Clinical Data Manager (CDM) ongoingly to ensure timelines are met.
  • Supports lead CDM in coding related tasks to ensure cleanliness and completion.
  • Provides status updates to the lead CDM on study specific coding completion and/or review.
  • Participates in CRF review impacted by coding needs.
  • Participates in CRFs Completion Guidelines review impacted by coding needs.
  • Contributes to DM coding strategies, guidelines, and conventions.
  • Contributes to the development of training manuals, coding conventions and SOPs in collaboration with Biometrics, Clinical Operations, Global Patient Safety and Clinical Research groups.
  • Collaborates with the Electronic Data Capture (EDC) programming group in coder implementation, up versioning of dictionaries.   
  • Train other team members in MedDRA, WHO Drug coding practices and assist other team members to resolve complex coding issues.
  • May assist DM with SAE reconciliation activities as needed.
  • Assist to create coding reports for study team’s review.
  • Embody and champion Zymeworks’ values: Act with Integrity. Collaborate. Care. 

Qualifications and Experience 

  • Bachelor’s degree in scientific discipline (e.g. life science, nursing, pharmacy) and a minimum of 7 years of clinical data management or may consider and equivalent combination of education and experience.
  • Fully conversant in medical coding dictionaries MedDRA and WHO Drug.
  • Experience performing medical coding using MedDRA and WHO Drug dictionaries.
  • Experience with Medidata Coder.
  • Proven interpersonal skills and the ability to work independently and 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 dymanic, fastpaced enviroment.
  • 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.
  • Thorough knowledge of FDA regulations, ICH GCP guidelines, database development, medical coding, and the drug development process.
  • Thorough knowledge of clinical medical coding including general principles of coding concomitant medications, WHODrug Best Practices, Drug Codes, the ATC System, and ATC Classifications in WHODrug.
  • Understanding of medical concepts, biology and chemistry in support of medical encoding.
  • MedDRA CMC Certification (desired).

Why Work for Us?

At Zymeworks, we stand for innovation, integrity, collaboration and care.

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 https://jobs.jobvite.com/zymeworkscareers.

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

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.