Senior Manager Clinical Study Lead

At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop, and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health.

Regeneron is seeking a Senior Manager Clinical Study Lead to operate with high degree of independence and is accountable for the global execution of assigned large and / or complex clinical trials from study design, through execution, to study close out.

Senior Manager Clinical Study Lead – Dublin / London

Hybrid – 3 days in the office)

The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH / GCP. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives.

As a Senior Manager CSL, a typical day might include the following :

• Leads the cross-functional study team responsible for clinical study / research collaboration delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
• Ensures development of study specific documentation such as samples management plans and data management plans are completed on time and in accordance with the study protocol.
• Oversees set-up and maintenance of study systems which may include Clinical Trial Management System (CTMS), Trial Master File (TMF), study SharePoint etc.
• Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors, if appropriate
• Provides input into baseline timeline development and management
• Ensures accurate budget management and scope changes for internal and external studies
• Works closely with clinical site staff, predominantly at academic institutions
• Oversees the execution of the clinical study against planned timelines, deliverables and budget
• Oversees and ensures Third Party Vendors are in alignment and are delivering per the scope of work
• Assigns tasks to Clinical Study Management staff and supports their deliverables
• Recommends and participates in cross-functional and departmental process improvement initiatives
• Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs
• Manages and oversees study close-out activities
• Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support / oversight

This role might be for you if :

To be considered for this opportunity , you must possess a Bachelors’ degree with a minimum of 6 years of relevant industry experience. Advanced degrees may be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. You will also need technical proficiency with trial management software and MS applications to be considered.