Manager, Clinical Data Management (Part-Time/Remote Optional)

San Francisco Bay Area, CA
Part-time


The Manager, Clinical Data Management is the primary point of contact providing guidance and oversight of clinical data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives.

Role and Responsibilities

  • Manage and oversee Data Management vendors or CRO partners
  • Develop data management plans that deliver accurate, timely and consistent clinical data.
  • Build, review, and maintain clinical databases, data collection tools, and applications. Create, review, and maintain study documentation, such as Case Report Forms (CRFs) and Data Transfer Agreements (DTAs).
  • Contribute to protocol development and review. Compile, analyze, clean, and validate clinical trial data. Identify and resolve discrepancies and issues with clinical data.
  • Develop data management reports and monitor study status to ensure timelines are met. Represent the data management function to key internal and external stakeholders.
  • Work collaboratively with clinical research and operations team to ensure accurate and complete data collection.
  • Recognized as subject matter expert and advanced individual contributor professional. Requires specialized skill set. Conducts highly complex work, unsupervised and with extensive latitude for independent judgment.

Education Requirements

  • Bachelor’s or master’s degree (or international equivalent)

Experience

  • At least 8 years of clinical data management experience
  • Experience running clinical trials outsourced to a CRO as well as managed in-house
  • Knowledgeable in GCP, CDISC standards, clinical trial guidelines & Data Management Best Practices
  • Ability to ‘wear many hats’, and self-motivated to take on new challenges
  • Track record of success in a deadline-driven and multi-task environment
  • Well organized and detailed oriented

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