Clinical Data Management Lead

4 weeks ago

Uxbridge, United Kingdom Pharmiweb Full time
Job Summary

The Associate Director, Program Clinical Data Management Lead will be responsible for the leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual will oversee data management activities and decisions, including quality, timelines, and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations, and company Standard Operating Procedures (SOPs) within assigned programs.

Key Responsibilities
  • Lead the development and implementation of CDM strategies and plans to ensure the success of clinical research studies.
  • Oversee the management of CDM study budgets, including review of initial study budget and handling of budget changes throughout the program lifecycle.
  • Ensure the use of standards for data collection and cleaning, and implement timelines to ensure quality results.
  • Manage all aspects of Quality Events, CAPAs, SSNs, and process deviations across the program.
  • Identify and recommend changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development.
  • Participate in Joint Meetings with Collaborative Partners at the study level and program level.
  • Ensure inspection readiness throughout the clinical program lifecycle, and coordinate and manage CDM activities during Regulatory Authority Inspections.

Requirements
  • Bachelor's degree in Mathematics, Science, or a related field.
  • Minimum of 12 years of clinical data management experience in biotechnology, pharmaceutical, or health-related industry.

About Us
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

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