Senior Manager/Associate Director, Data Management

Location
Vancouver, British Columbia (CA)
Salary
Commensurate with experience
Posted
Jun 01, 2017
Closes
Jul 25, 2017
Category
Other, Pharmaceutical
Hours
Full Time

                        

Senior Manager/Associate Director, Data Management

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation 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.

Key Responsibilities

  • Provides clinical data management support to the Clinical operations team and/or study project ensuring the delivery of high quality data from project start-up to project execution and close-out.
  • Develops and/or is accountable for the Data Management Plan, maintaining the plan throughout the lifecycle of study project and ensuring it is followed in accordance with study design and requirements.
  • Performs and/or is accountable for clinical database setup, testing, maintenance and data quality control functions through database lock in accordance with GCP, ICH and SOPs. Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
  • Performs and/or is accountable for data management study start-up activities including CRF/eCRF design; developing database specifications; defining validation specifications, edit rules/checks, query logic, data validations and user acceptance testing.
  • Performs and/or is accountable for all data management activities such as data collection and entry, database access requirement implementation, data cleaning, training, and/or other tasks associated with the clinical trial database.
  • Participates in the review of clinical research documents (ie: Protocols, Case report Forms, Reports and Statistical analysis).
  • Participates in internal/sponsor meetings and training programs as required, works directly with assigned project manager and team to provide data management support.
  • Provides oversight and manages multiple CROs on a Medidata platform and experience in governance for multiple CROs working on same URL is preferred.
  • Ensures approved study documentation is maintained and properly stored in the trial master files.
  • Communicates project status updates and key project issues to management on a regular and timely basis.
  • Manages project resources according to budget and within timeframes.
  • Fosters effective and collaborative working relationships with fellow employees, management and external partners.

Education and Experience

University degree in a health-related field and a minimum of 5 to 8 years’ related experience within the pharmaceutical industry (oncology preferred) or an equivalent combination of education and experience.

Skills and Abilities

  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
  • Clinical or medical knowledge and skills required, oncology research specific knowledge and experience preferred.
  • Working knowledge of GCP, GMP, clinical research, clinical trial process and related regulatory requirements and terminology.
  • Proficient with clinical database applications such as Medidata RAVE and report tools.
  • Experience with working on Phase I-IV study trials.
  • Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment.
  • Good project coordination skills and effective oral and written communication skills.
  • Strong attention to detail and good analytical skills.
  • Proficiency with MS Office.

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.

How to Apply

If you are interested in this challenging and rewarding position, please email your resume and cover letter to careers@zymeworks.com with “Senior Manager/Associate Director, Data Management” in the subject line.

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