Careers

Clinical Data Manager / Sr. Clinical Data Manager

Description

Neoleukin Therapeutics is looking for an experienced Clinical Data Manager to join our Clinical Operations team.  The Clinical Data Manager will develop, collect, analyze, apply and oversee the clinical trial data (pre-IND through Phase 1-4) for oncology and autoimmunity contributing to our clinical development program(s). This position will report to the Head of Clinical Operations and will be based in Seattle, WA. If you are a resourceful, independent, collaborative clinical development expert looking to join a fast-growing organization, please apply!


Responsibilities

  • Oversee DM activities and timelines across all studies and programs
  • Serve as the Clinical Data Manager on multiple studies
  • Responsible for the build, review, validation and amendments to the clinical database
  • Create and maintain DM documents including Data Management Plan, Data Review Plan, CRF completion guidelines and data validation specifications for edit checks
  • Oversee and facilitate scheduled internal data review cycles and data trend analysis
  • Manage CDM activities with CRO and other vendors including development and implementation of data transfer plans
  • Perform edit checks, trend analysis and risk assessment and report data errors or quality concerns
  • Develop and maintain company standard CRFs
  • Embed within CDM outsourced team; drive data review and swift delivery of outputs as needed
  • Adhere to CDISC and SDTM standards
  • Represent as Clinical Data Management subject matter expert (SME)
  • Train and develop direct reports


Qualifications

  • Bachelor’s degree preferred, ideally in a scientific or healthcare discipline
  • Minimum of four (4) years experience in Clinical Data Management and minimum of two (2) years experience in all aspects of database development
  • Working knowledge of CDISC/CDASH, MedDRA coding, and Medidata Rave EDC
  • Working knowledge of Good Clinical Practices, CFR21 Part 11, ICH, HL7 and other regulations and standards
  • Excellent oral, written, and medical communication skills required
  • Strong self-awareness, with proactive and positive approach to problem solving
  • Ability to thrive in a fast-paced, entrepreneurial environment and function as an independent contributor at a high level in a team setting
  • Flexibility to adapt to changing needs in real time
  • Excitement about the vision and mission of Neoleukin Therapeutics


Applications can be submitted to careers@neoleukin.com

Neoleukin Therapeutics is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or age, and Neoleukin will not tolerate discrimination or harassment based on any of the above characteristics.