Remote Senior Manager, Clinical Data Management

Regeneron Pharmaceuticals, Inc.

United States

Remote

USD 134,000 - 219,000

Full time

2 days ago
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Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, Clinical Data Management to lead data management delivery for clinical studies in a remote-friendly model in the US.

You will supervise a data management team, collaborate with study teams, CROs and external vendors to ensure data quality and regulatory readiness. The role requires a Bachelor’s degree in a scientific field, 8+ years’ data management experience, knowledge of 21 CFR Part 11, ICH-GCP, CDISC, and demonstrated people

Qualifications

  • Bachelor's degree required in mathematics, science, or related field.
  • 8+ years of clinical data management experience in biotech/pharma or health-related industry.
  • Proven record of leading studies and study teams in data processing environments.
  • Knowledge of 21 CFR Part 11, ICH-GCP, and CDISC.
  • Strong problem-solving, project management, and communication skills; ability to manage virtual teams.
  • 3+ years of people management experience preferred.
  • CCDM certification preferred.

Responsibilities

  • Serve as the data management study lead and primary contact for study teams, CROs, and external data vendors across multiple trials.
  • Oversee data management activities from study start-up through database lock and archiving.
  • Provide sponsor oversight of CRO data management work, identifying gaps and driving resolution.
  • Review and approve key study documentation, including data management plans, CRF design, and data transfer specifications.
  • Maintain inspection readiness and eTMF documentation to meet quarterly compliance reviews.
  • Monitor data quality, deliverable timelines, and risks, signaling issues proactively.
  • Manage, coach, and develop data management staff, including recruitment and performance management.
  • Recommend process improvements, lead cross-functional initiatives, and act as a subject matter expert delivering training.

Education

Bachelor's degree in Mathematics, Science, or a related field

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, Clinical Data Management to lead data management delivery for clinical studies in a remote-friendly model in the US.

You will supervise a data management team, collaborate with study teams, CROs and external vendors to ensure data quality and regulatory readiness. The role requires a Bachelor’s degree in a scientific field, 8+ years’ data management experience, knowledge of 21 CFR Part 11, ICH-GCP, CDISC, and demonstrated people

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