The Manager, Site Start Up is central to advancing REGN's document management and communication capabilities. With a focus on extended Veeva Vault Clinical system implementation and Site Portal, we expect that you will ensure the systems' usability, efficiency, and alignment with business objectives are optimal. We believe the Manager will also be responsible for the introduction and adoption of relevant technologies that enable business processes.

Site Initiation and Regulatory Packages

• Gathers all documents required for the purposes of enabling Site Initiation; includes the compilation of documents from multiple internal stakeholders and supporting functions to then distribute to the site in a structured and time sensitive manner.

• Identifies and tracks those documents that require translations/linguistic validations and works with translation support services to define the scope of work and critical timelines for deliverables.

• Participates as necessary, in obtaining clinical trial insurance for studies/sites Facilitates the clinical trial insurance process; works as necessary with the insurance vendor and Regeneron insurance group to ensure timely deliverables in preparation for patient enrollment and support throughout the conduct of the clinical study. May contribute to review of Subject Informed Consents to ensure alignment with insurance language.

Study Investigator Site Essential Document Oversight

• Serves as study expert on investigator site essential documentation

• Develop and maintain Regeneron documentation of expectations / standards of investigator site essential documentation

• Provide training to internal and external study teams on the expectations / standards of investigator site essential documentation.

• Review investigator site essential documentation packages from CROs per process and sample as needed

• May collaborate directly with sites regarding collection of documents and IRB timelines for site activation and ensure that relevant documents are uploaded into the eTMF.

• Collect study specific metrics and feedback and provide to internal and external study teams (including CRO partners) and Regeneron management as required.

• Assists in inspection readiness activities in relation to site start up documents

• Participates in lesson learned opportunities to retrain study teams and CROs understand what has worked or not to prevent repeating past mistakes.

Study Team Interaction

• May represent Site Start up on cross-functional study team (s) and/or sub-team(s); Attends Kick Off meetings to present SSU Roles and Responsibilities

• Works with and provides status to study team to ensure essential documentation packages are approved for initial drug shipments according to study timelines. Supports Clinical Study team in ensuring regulatory documents are submission and audit ready escalates as necessary

• Collaborates with CRO and internal team to ensure timely feedback / resolution of document issues