Clinical Data Management Lead

1 month ago


Tarrytown, New York, United States Lifelancer Full time
Job Description

The role of Clinical Data Management Lead is an exciting opportunity to oversee clinical data management projects in specific therapeutic areas, ensuring accurate planning and execution that meets Regeneron standards within timelines.

Responsibilities:
  • Serves as primary DM contact to interact with clinical counterparts for overall project planning and issue resolution, allocating and prioritizing DM resources within the assigned therapeutic projects.
  • Supervises DM reports for planning and managing all relevant DM activities within the assigned therapeutic areas for timely and quality deliverables and within budget, mentoring junior data managers for skill set advancement.
  • Ensures all databases are developed, validated, and ready for transfer and/or analysis according to policies and procedures, SOP's, and work instructions in compliance with applicable regulations.
  • Reviews and approves for final archival of project documentation, including Data Management Manual, CRF Completion Guidelines, validation specifications, and work instructions for assigned projects.
Requirements:
  • Requires experience supervising team for initiation and approval of building, and validation of clinical databases, subsequent changes in clinical databases, and data validation activities, coordinating with clinical project teams for issue resolution.
  • Contributes to upkeep Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners, ensuring data quality and efficiencies through data and process standardization.
  • Ensures adequate management of CROs and vendors in therapeutic projects, coordinating all data management functions.
  • Establishes goals, expectations, and accountabilities for direct reports, regularly reviewing DM performance in respect to quality and timeliness standards according to Regeneron SOPs and working procedures.
Salary and Benefits

This role offers a competitive salary range of $110,900.00 - $181,100.00 annually, along with comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.


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