Manager, Global Site Start-Up Lead

Role Overview

• 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 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.

Requirements

• A Bachelor's degree and 6+ years relevant work experience
• 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
• May require up to 25% travel

Tech Stack

• Google Cloud Platform

Benefits

• 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
• Family support benefits