Temp Global Site Start Up Lead

Regeneron Pharmaceuticals•Warren, MI

2d•Hybrid

About The Position

The Manager, Global Site Start-Up Lead (SSU Lead) is responsible for driving the global execution of site activation for clinical trials, performing the role with moderate oversight to ensure efficient and compliant processes aligned with Regeneron SOPs, ICH-GCP guidelines, and industry standards. Partnering closely with cross-functional teams and Clinical Research Organizations (CROs), this role balances strategic oversight with hands-on leadership to address challenges and deliver study objectives. The SSU Lead develops site activation projections, mitigates risks impacting site activation, and monitors CRO performance by analyzing metrics. Additionally, they lead all aspects of site start-up activities, including fast-track initiation, milestone tracking, and document collection, while ensuring timely submissions and leveraging country intelligence for informed decision-making.

Requirements

Moderate oversight required
Efficient and compliant processes aligned with Regeneron SOPs, ICH-GCP guidelines, and industry standards
Partnering closely with cross-functional teams and Clinical Research Organizations (CROs)
Balances strategic oversight with hands-on leadership
Develops site activation projections
Mitigates risks impacting site activation
Monitors CRO performance by analyzing metrics
Leads all aspects of site start-up activities, including fast-track initiation, milestone tracking, and document collection
Ensures timely submissions
Leverages country intelligence for informed decision-making
Oversee the tracking and analysis of study metrics
Evaluate CRO performance and implement corrective actions
Advocate for optimized site selection strategies
Leveraging data-driven insights
Lead the development, assessment, and alignment of site activation projections
Ensuring cross-functional and CRO collaboration
Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF)
Partner with cross functional and CRO partners (where applicable)
Develop a comprehensive global country start up strategy
Monitor and maintain country intelligence data
Support regulatory submissions as needed
Providing required site documentation
Coordinating submissions to Central Institutional Review Boards (CIRBs)
Supporting sites with Local Institutional Review Board (LIRB) submissions
Handling or supervising Clinical Research Organization (CRO) insurance requests
Ensure timely country submission deliverables
Lead and oversee all aspects of site start-up activities
Serve as the subject matter expert for essential site documents
Providing training, guidance, and support to teams and sites on regulatory requirements, document management, and TMF filing.
Oversee CRO site start up management or in house site facing regional SSU team, where applicable
Lead the collection and analysis of site intelligence
Oversee the preparation and approval of site regulatory package
Ensuring compliance with country-specific requirements, TMF standards, and ICH-GCP guidelines
Represent SSU on cross-functional teams
Providing updates, escalating challenges, and proposing mitigation strategies for site start-up issues.
Act as the escalation point for CRO and internal team to ensure timely SSU issue resolution
Recommends and participates in cross functional and department process improvements.

Nice To Haves

Build our future together: Within Regeneron, there are a growing number of diverse collaborations and alliances with external entities. This individual will help to build productive external partnerships across several key areas.
The Director will support the identification, execution and management of overarching strategic relationships with various organizations and institutions to support the Global Clinical Development organization’s efforts to more effectively develop Regeneron’s product candidates and advance the company’s broader R&D objectives.
The individual will function as a strategic and critical thinker, identifying and developing key external relationships and coordinating across a matrix of teams with the purposes of finding opportunities and streamlining external partnership initiation and maintenance.
They will be focused on further building an internal capability on behalf of Regeneron that is highly-regarded by external partners and internal leaders.
The individual will partner closely with other internal leaders embedded in the company who work with external partners to ensure collaboration, continuity and alignment.
This role will be highly collaborative with other functions and will require thoughtful and inclusive leadership.
This role will be tasked with not only identifying strategic partnerships, but facilitating the drafting and execution of contracts, as well as remaining connected to the overarching relationships, while helping to facilitate the components that live in specific areas throughout the life of the agreements.

Responsibilities

Develop the site start up strategy for each study, outlining all dependencies impacting site activation and actively mitigating and escalating risks.
Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions.
Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making.
Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives.
Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness.
Partner with cross functional and CRO partners (where applicable) to develop a comprehensive global country start up strategy, outlining all dependencies impacting country start up and actively mitigating and escalating risks cross functionally.
Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans.
Support regulatory submissions as needed, including activities such as: providing required site documentation, coordinating submissions to Central Institutional Review Boards (CIRBs), supporting sites with Local Institutional Review Board (LIRB) submissions, and handling or supervising Clinical Research Organization (CRO) insurance requests, etc.
Ensure timely country submission deliverables (ensure task completion; all roles clarity, identification of critical path items, effective communication pathway).
Lead and oversee all aspects of site start-up activities, including fast-track site initiation, site calls, document collection, and milestone tracking, ensuring timely and efficient completion of processes.
Serve as the subject matter expert for essential site documents, providing training, guidance, and support to teams and sites on regulatory requirements, document management, and TMF filing.
Oversee CRO site start up management or in house site facing regional SSU team, where applicable
Lead the collection and analysis of site intelligence to support strategic site selection and site start-up.
Oversee the preparation and approval of site regulatory package, ensuring compliance with country-specific requirements, TMF standards, and ICH-GCP guidelines, while supporting inspection readiness and maintaining high-quality site documentation.
Represent SSU on cross-functional teams, providing updates, escalating challenges, and proposing mitigation strategies for site start-up issues.
Act as the escalation point for CRO and internal team to ensure timely SSU issue resolution
Recommends and participates in cross functional and department process improvements.