Clinical Data Management Lead
3 weeks ago
The Program Clinical Data Management Lead is responsible for strategic leadership and management of clinical data management programs.
This individual oversees data management activities, including quality, timelines, and resources, to ensure compliance with regulations, ICH/GCP, and company SOPs within assigned programs.
As a member of the Clinical Data Management extended leadership team, this role interacts with senior management, vendors, partners, and clinical study personnel for project and department initiatives.
Key Responsibilities:
- Ensure overall success of clinical data management programs.
- Maintain program status and issues, and proactively communicate progress, risks, and changes that impact quality, timelines, and budget.
- Implement quality results, timelines, and consistency of process and approaches across clinical study results.
Requirements:
- Point of contact for clinical program and study level escalation.
- Review key metrics and KPIs to track study progress.
- Manage Quality Events, CAPAs, SSN, and process deviations across the program.
- Identify and recommend changes to practices and policies, including strategic projects and initiatives.
- Ensure inspection readiness and coordinate CDM activities during Regulatory Authority Inspections.
Qualifications:
- Bachelor's degree in Mathematics, Science, or a related field.
- Minimum 12 years of clinical data management experience in biotechnology, pharmaceutical, or health-related industry.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, 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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Uxbridge, United Kingdom Regeneron Pharmaceuticals Inc. Full timeJob Title: Associate Director, Program Clinical Data Management LeadThe Clinical Data Management Lead is a key member of the Clinical Data Management team, responsible for the overall strategic management of clinical data management activities within assigned programs. This role requires strong leadership and communication skills, as well as the ability to...
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