Data Manager

  • Competitive
  • Redmond, United States
  • Permanent

Key Responsibilities:

  • Provide leadership in Data Management (DM) across multiple studies, formulate data management strategies, and establish procedures.
  • Conduct DM activities during study startup, including the preparation of eCRFs, CCGs, Data Management Plan (DMP), Data Validation Plan (DVP), External Data Transfer Plan (DTP), and perform user acceptance testing (UAT).
  • Lead or actively participate in DM tasks throughout the study, managing the collection, transmittal, and transfer of clinical trial data, and overseeing query management. Coordinate and lead Serious Adverse Event (SAE) reconciliation.
  • Perform Medical Coding as needed, collaborating with CROs and Medical Monitors to facilitate the medical review of clinical trial data.
  • Organize data validation meetings, compile data validation reports, and execute database locking procedures.
  • Develop Standard Operating Procedures (SOPs) and ensure regulatory compliance, monitoring adherence to guidelines such as Good Clinical Practice (GCP) and other relevant regulations.
  • Provide oversight of CRO data management activities, integrating input from various functional groups.
  • Undertake any other duties as assigned.

Education/Experience Requirements:

  • Bachelor's degree (BA or BS) with a minimum of 2 years of experience managing large-scale data projects to support research or analysis.
  • Proficiency in working with Clinical Electronic Data Capture (EDC) systems such as OpenClinica, Medrio, or Medidata Rave.
  • Familiarity with ICH-GCP, CDISC/CDASH standards, and relevant regulatory guidelines.
  • Strong knowledge of clinical research, drug development processes, and medical terminology, with a preference for oncology experience.
  • Familiarity with MedDRA and WHO Drug coding.
  • Excellent oral and written communication skills.
  • Project management skills, with the ability to manage multiple projects and meet deadlines.
  • Strong interpersonal, organizational, and communication skills.
Sarah McGraw Division Manager

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