**Job Description**
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Senior Clinical Study Manager Lead:
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The Senior Clinical Study Manager is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. This role leads cross-functional study teams responsible for clinical study delivery and is the primary point of contact for leadership and oversight.
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Key Responsibilities:
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* Operate with a high degree of independence and accountability for study timelines, study budget, and ensuring study conduct in accordance with SOPs and ICH/GCP.
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* Provide operational input into protocol development and oversee the development of study specific documentation including CRFs, data management plans, monitoring plans, and statistical analysis plans.
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* Set up and maintain study systems including CTMS and TMF and ensure compliance with clinical trial registry requirements.
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* Identify outsourcing needs and lead engagement, contracting, and management of required vendors.
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* Lead risk assessment and identify risk mitigation strategies at the study level.
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* Develop and oversee implementation of patient recruitment and retention strategies.
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* Monitor data entry and query resolution and act on any deviations from agreed metrics.
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* Escalate issues related to study conduct, quality, timelines, or budget to Program Operations Leader and other stakeholders.
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* Oversee execution of clinical studies against planned timelines, deliverables, and budget.
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* Ensure data quality and oversee CROs and Third Party Vendors in alignment with scope of work.
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Requirements and Qualifications:
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The ideal candidate will have:
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* Exceptional interpersonal and leadership skills.
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* Advanced expertise and strategic direction in clinical studies.
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* Expert knowledge of industry trends and negotiation skills.
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* Strong budget management experience and technical proficiency in trial management systems.
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* Extensive experience in global clinical trial operations with unique knowledge and skills.
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* Line management experience and advanced project management skills.
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* A minimum of 8 years relevant clinical trial experience.
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Benefits:
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Regeneron offers a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees.
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Others:
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Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to protected characteristics.
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