Senior Manager Global Study Start Up

Responsibilities Drive global execution of site activation for complex, high‑profile clinical trials. Develop site start‑up strategy for each study, outlining all dependencies and proactively mitigating and escalating risks. Oversee tracking and analysis of study metrics, evaluate CRO performance, and implement corrective actions. Advocate for optimised site selection strategies using data‑driven insights to guide cross‑functional teams. Lead the development, assessment, and alignment of site activation projections. Ensure comprehensive and compliant documentation of site start‑up materials in the Trial Master File (TMF). Partner with cross‑functional and CRO teams to develop a global country start‑up strategy. Maintain country intelligence data to support informed decision‑making and accurate startup projections. Support regulatory submissions, including coordinating with CIRBs, assisting sites with LIRB submissions, and overseeing CRO insurance requests. Lead and oversee all aspects of site start‑up activities for complex, high‑profile studies including fast‑track initiation, site calls, document collection, and milestone tracking. Serve as subject‑matter expert for essential site documents; provide 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. Collect and analyse site intelligence to support strategic site selection and start‑up. Prepare and approve site regulatory packages, ensuring compliance with country‑specific requirements, TMF standards, and ICH‑GCP guidelines. Act as escalation point for CRO and internal teams to ensure timely issue resolution. Recommend and drive cross‑functional and departmental process improvements. Qualifications Minimum Bachelor's degree and 8+ years of relevant industry experience. Strong interpersonal and leadership skills. Ability to provide and implement operational strategic direction and guidance for respective clinical trials. Strong knowledge and data‑driven approach to planning, execution, and problem‑solving. Strong communication skills (verbal, written, and presentation). Proactive, self‑disciplined, and able to meet deadlines with effective prioritisation. Ability to influence and negotiate across a wide range of stakeholders. Experience leading and developing productive study teams and collaborations. Advanced negotiation and interpersonal skills for vendor management. Technical proficiency in trial‑management systems (CTMS, TMF) and MS Office (Project, PowerPoint, Word, Excel). Extensive experience in the clinical drug‑development process, including study start‑up. Knowledge and understanding of ICH/GCP and regulatory guidelines/directives. Strong project‑management, cross‑functional team interaction, and organisational skills. Experience in line management preferred. Preference for siting experience in a sponsor site start‑up role. Travel May require up to 25% travel. Salary $134,400 – $219,200 annually. Benefits We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centres, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. Equal Opportunity Employer 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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveller community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc (USA)