Manager, Global Study Start-Up

Regeneron Pharmaceuticals; Armonk (NY); Presencial; USD 115.000 - 187.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals is seeking a Manager, Global Site Start-Up Lead (SSU Lead) to drive global site activation for clinical trials. You will partner with cross-functional teams and CROs to deliver timely, compliant site initiation with strong metrics oversight and TMF documentation.

This role involves fast-track initiation, milestone tracking, and strategic country start-up planning. Key responsibilities include leading site activation projections, risk mitigation, and CRO performance

Formación

• Proven leadership in site start-up or clinical operations.
• Strong project management and cross-functional collaboration skills.
• Experience with regulatory guidelines and ICH-GCP.
• Vendor management and CRO oversight experience.

Responsabilidades

• Develop site start-up strategy and projections, mitigate risks, and track metrics.
• Oversee CRO performance and implement corrective actions as needed.
• Lead fast-track initiation, milestones, and document collection for TMF readiness.
• Advocate for optimized site selection using data-driven insights to guide teams.
• Coordinate regulatory submissions and country start-up activities with CROs and sites.
• Provide training on regulatory requirements and TMF filing to teams.
• Travel up to 25% as required.

Conocimientos

Leadership

Project management

Cross-functional collaboration

Vendor management

Regulatory knowledge ICH-GCP

CTMS proficiency

TMF proficiency

Stakeholder management

Herramientas

CTMS

TMF

Microsoft PowerPoint

Microsoft Word

Microsoft Excel

Descripción del empleo

Build our future together:

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.

When & where:

• Primary Location: Armonk, NY
• Additional Locations: Warren, NJ

Discover Your Role

Site Start‑Up Strategy

• Develop the site start‑up strategy for each study, outlining all dependencies impacting site activation while actively mitigating and escalating risks. Oversee the tracking and analysis of study metrics — including risks and mitigation strategies — 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.

Country Start‑Up

• 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 while actively mitigating and escalating risks cross‑functionally.
• Monitor and maintain country intelligence data to support informed decision‑making and develop accurate start‑up projections and strategic plans.
• Support regulatory submissions as needed, including:
• 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 (task completion, role clarity, identification of critical path items, and effective communication pathways).

Site Start‑Up Management

• 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 the 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 packages, ensuring compliance with country‑specific requirements, TMF standards, and ICH‑GCP guidelines, while supporting inspection readiness and maintaining high‑quality site documentation.

Team Interactions

• Represent Site Start‑Up (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 teams to ensure timely SSU issue resolution.

Process Improvement

• Recommend and participate in cross‑functional and departmental process improvements.

Travel

• May require up to 25% travel

This role requires:

• Demonstrated interpersonal & leadership skills
• Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
• A data driven approach to planning, executing, and problem solving
• Effective communication skills via verbal, written and presentation abilities
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Ability to influence and negotiate across key stakeholders
• Ability to build productive study teams collaborations
• Experience in the clinical drug development process, with expertise in study start‑up
• Demonstrated vendor management experience
• Technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Effective project management skills, cross‑functional team interaction and organizational skills

Does this sound like you? We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$114,800.00 - $187,400.00