Clinical Data Management Lead

4 weeks ago


South San Francisco, California, United States Denali Full time

Job Summary

Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases. We are seeking a highly skilled Clinical Data Management Lead to join our team. The successful candidate will be responsible for delivering high-quality data for analysis and study milestones, reviewing protocols from a CDM perspective, and providing functional-expert feedback. Additionally, the candidate will oversee study setup, testing, and system validation for new studies in partnership with the DM vendor.

Key Responsibilities

  • Deliver high-quality data for analysis and study milestones
  • Review protocols from a CDM perspective and provide functional-expert feedback
  • Oversee study setup, testing, and system validation for new studies in partnership with the DM vendor
  • Manage/oversee data cleaning activities executed by the DM vendor
  • Collaborate with internal Data Science, Biostatistics, and Medical Monitor on identifying critical variables in the clinical dataset
  • Develop and manage timelines for key clinical data management deliverables
  • Monitor vendor performance to ensure timelines and data quality standards are met

Requirements
  • BA/BS or higher in a math, science, or health-related field
  • Minimum of 5 years of experience in clinical data management across phase 1-3 clinical trials
  • At least 5 years of experience acting as a study lead data manager
  • Working knowledge of CDISC, including CDASH, TAUG, and SDTM, as well as data privacy regulations
  • Ability to work in a fast-paced and dynamic environment
  • Strong analytical and problem-solving skills

What We Offer
  • Competitive salary range: $135,000.00 to $166,667.00
  • Total rewards package, including 401k, healthcare coverage, ESPP, and other benefits

About Denali
  • Denali is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases
  • We are committed to creating a diverse and inclusive environment
  • We are an equal opportunity employer and do not discriminate against any employee or applicant for employment

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