Associate Director, Program Clinical Data Management Lead

2 weeks ago

Basking Ridge NJ United States Regeneron Pharmaceuticals, Inc Full time

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM).

This individual is responsible for 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 program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives.

In this role, a typical day might include:

  • Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM).

  • Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provides CDM program level updates to collaborators as requested.

  • Review of plans and provision of CDM expertise during protocol design, study start up and conduct phases of studies. Ensure consistency within the program and development of standard methodologies within CDM. Ensure use of standards for data collection and cleaning.

  • Ensure quality results, implement timelines and accountable for ensuring consistency of process and approaches across clinical study results.

  • Leads all aspects of program level result timelines ensuring proper resources are in place and supervising overlapping deliverables.

  • Oversees CDM study budgets within a program ensures review of initial study budget and handles the budget through the lifecycle of the program by communicating changes as appropriate.

This role might be for you if can:

  • Acts as point of contact for clinical program and study level escalation.

  • Reviews key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress.

  • Manages all aspects of Quality Events, CAPAs, SSN and process deviations across the program.

  • Identifies and recommends changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development.

  • Participates in Joint Meetings with Collaborative Partners at the study level and program level.

  • Ensures inspection readiness throughout the clinical program lifecycle, coordinates and manages CDM activities during Regulatory Authority Inspections.

To be considered for this opportunity, you must have the following:

  • 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 is required.

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