Director, Clinical Data Management — Data Quality & RBQM

Stoke Therapeutics

Tennessee

Hybrid

USD 225,000 - 244,000

Full time

14 days+
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Benefits offered by this job

Annual bonus
Equity participation
Medical insurance
Dental insurance
Vision insurance
401K match
Unlimited vacation
Tuition assistance
ESPP

Job summary

Stoke Therapeutics is seeking a Director of Clinical Data Management to lead data management across development programs, supervising CRO activities and ensuring high-quality data governance. The role emphasizes risk-based quality management, regulatory compliance, and data analytics to support statistical reviews.

The position supports hybrid/remote work in the United States, with potential relocation to Massachusetts as Stoke is expanding its data capabilities and program portfolio.

Qualifications

  • Bachelor’s degree or higher in a scientific or healthcare discipline.
  • 10+ years of progressive experience in data management within biotech/pharma/CRO settings; leadership experience.

Responsibilities

  • Lead data management activities for Stoke clinical studies; oversee CRO data management.
  • Manage Data Management team and budgets; ensure regulatory compliance and inspection readiness.
  • Establish RBQM approach; drive data analytics and dashboards for monitoring.

Skills

Data management leadership
CDISC standards
GCP & 21 CFR Part 11
Outsourced CDMS
Regulatory compliance

Education

Bachelor’s degree in science/healthcare

Tools

Medidata Rave
Veeva Vault CDMS
Spotfire/Power BI
SAS/R/Python

Job description

Stoke Therapeutics is seeking a Director of Clinical Data Management to lead data management across development programs, supervising CRO activities and ensuring high-quality data governance. The role emphasizes risk-based quality management, regulatory compliance, and data analytics to support statistical reviews.

The position supports hybrid/remote work in the United States, with potential relocation to Massachusetts as Stoke is expanding its data capabilities and program portfolio.

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