Regeneron is seeking a highly experienced Clinical Data Management Lead to lead our Program Clinical Data Management function. As a key member of the Clinical Data Management extended leadership team, you will be responsible for strategic management of Programs in Clinical Data Management (CDM).
About the Role
This senior leadership position involves oversight of 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.
You will be working closely with senior level management, external vendors, collaboration partners, and clinical study personnel for clinical research project and department initiatives.
Responsibilities
* 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; provide 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.
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 is required.
If you have a passion for leading high-performing teams and driving business growth through innovative strategies, we encourage you to apply.