Clinical Study Operations Director
1 day ago
Regeneron Ireland DAC Senior Manager Clinical Study Lead Job Overview:
This role is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior Manager Clinical Study Lead operates with high-degree of independence and is responsible for ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.
Key Responsibilities:
- Leverage advanced expertise to implement operational strategic direction and guidance for respective clinical studies.
- Oversee cross-functional study teams responsible for clinical study delivery and provide leadership and oversight as required.
- Provide input into protocol development, data management plan, monitoring plan, and statistical analysis plan.
- Ensure compliance with clinical trial registry requirements and lead risk assessment and mitigation strategies at the study level.
- Develop and oversee implementation of patient recruitment and retention strategies.
- Monitor progress for site activation and monitoring visits and act on any deviations from plan.
- Escalate issues related to study conduct, quality, timelines, or budget to Program Operations Leader (POL) and other stakeholders.
Requirements:
- Bachelor's degree with a minimum of 8 years of relevant industry experience.
- Demonstrated expertise in global clinical trial operations, including experience developing protocols and key study documents.
- Technical proficiency in trial management software and MS applications.
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