Clinical Data Management Leader

5 days ago


Watertown, Massachusetts, United States Upstream Bio Full time
About the Role

We are seeking a seasoned Clinical Data Management (CDM) leader to oversee clinical data acquisition planning and implementation for our Phase 2 trials in severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), as well as our upcoming trial in chronic obstructive pulmonary disease (COPD).

Responsibilities
  • Clinical Data Management Oversight: Ensure compliance and quality of data acquisition planning and implementation, driving innovation in data management processes, tools, and emerging technologies.
  • CRO Vendor Oversight: Oversee clinical data management activities carried out by Contract Research Organizations (CROs) and exercise vendor oversight of clinical data deliverables, ensuring both quality and adherence to timelines.
  • Data Quality Risk Management: Identify and evaluate impact of data quality risks and issues through examination of the clinical database, vendor database, and Central Monitoring, collaborating closely with cross-functional teams to implement solutions.
  • Team Leadership: Lead the Data Management team, working alongside team members in executing key data management tasks, fostering an environment of collaboration and continuous improvement.
  • Compliance and Audit Readiness: Ensure all processes are compliant with industry regulations, company standards, and audit requirements, maintaining accurate records of data management activities.
Requirements
  • A bachelor's degree and minimum 10 years of clinical data management experience.
  • In-depth knowledge of clinical data management processes, systems, technologies, and industry advancements; proven CDM leadership role in late-phase clinical trials with experience overseeing trials from start-up through database lock.
  • Demonstrated strategic thinking with substantial experience in CRO oversight throughout clinical trials, including case report form development, database development, data validation, data reporting, and database lock activities.
  • Strong hands-on skills in managing essential electronic data collection platforms, including EDC, clinical laboratory, eCOA, imaging, etc. Experience in risk-based central monitoring is essential.
  • Excellent analytical skills with attention to detail, combined with effective communication and problem-solving abilities.
Estimate Salary Range

$140,000 - $170,000 per year, based on location and experience.



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