Vendor Management Lead, Global Regulatory Affairs. Lead vendor manager for Key Providers with aim to improve the Outsourced Partner model for scalability and flexibility. Optimize the scope of vendor activities and implement a flexible resourcing model. Simplify our 3rd party landscape and improve vendor performance. Build a collaborative governance structure to gain alignment & cohesion across all GRA for Key Providers. Remain competitive and supportive of Sanofi regulatory journey. Optimize and streamline contracts. Identify synergies and simplification across numerous contracts currently in place. Support the functions in the development and modification of business cases. This includes validating the need, approach, ROI, and track that the delivered effort by the vendor achieved the business case using KPIs and other indicators. and will ensure that all supportive data elements are properly documented and stored. Participate in managing budget forecast and actuals in conjunction with line managers, procurement and controllers. Ensure internal/external resources are maximized (people and finance) while maintaining/increasing level of quality/performance in partnership with key stakeholders.

Spearhead Global ONE program for clinical study unit (CSU) monitoring services, enforcing consistent delivery of monitoring services globally. Oversee 1,500 employees and €250M budget. Collaborate closely with international service providers in Europe, Asia, and Americas (US, Canada, and Latin America). Manage all aspects of study monitoring and delivery, including investigator site visits, data collection, and data analysis; ensure providers meet quality, financial, and ethical requirements and comply with service agreements. Evaluate data and recommend process improvements to enhance safety and minimize risks. Fine-tune existing operating guidelines, driving savings and productivity. Cultivate supportive environment that promotes collaboration and cohesion for staff and providers.

Led operational efforts for North American CSU studies managed by field CRAs, overseeing resource allocation, process optimization, decision-making, and prioritization of strategic plans. Supervised 6 direct reports, 9 dotted line reports, and 2 service providers, and provided indirect oversight of 500 contractors; managed $85M budget. Delegated responsibilities to employees, assigned studies, confirmed achievement of KPIs, and ensured proper placement and comprehensive training of specialized teams. Coordinated with partners in US and Americas to maintain business continuity on all projects and to guarantee proper study execution. Spearheaded recruitment efforts, as well as hiring, training, and mentoring of employees. Navigated provider attrition and other challenges and provided leadership to keep teams focused and motivated.

Provided support, direction, and oversight to clinical trial leaders, supervising execution of studies pertaining to diabetes and metabolism. Managed 14 direct reports and 22 indirect reports and oversaw $100M of local study budgets. Led teams pursuing diverse studies, ensuring achievement of priorities and alignment with company and departmental goals; mitigated any setbacks. Assumed accountability for commitments, timelines, quality requirements, and allocated budget. Trained, coached, and mentored personnel as subject matter expert. Evaluated and reported study updates, timelines, and quality assurance requirements to North America CSU Head of Project Management and stakeholders. Served as key interface for developing and maintaining operational processes for North American clinical trials.

Managed project delivery for Americas region, overseeing recruitment, planning, and logistics, and mediating between global trial operations team and local team. Ensured compliance with company standards, and adhered to timelines, milestones, and budget. Procured devices and staffed open roles as needed. Performed data analysis and data cleaning activities. Organized training sessions for monitoring teams, teaching team members about study processes, devices, and monitoring plan. Facilitated meetings with core trial team, local clinical project leaders, and other personnel.

Integrated successfully into team shortly after Genzyme and Sanofi merged, assuming wide range of responsibilities. Oversaw vendor operations for Genzyme’s specialty care global business unit, managing project timelines, vendor budgets, and progress reporting. Coordinated with vendors across multiple studies, establishing workflows for lab tests, EKG reviews, and other procedures, and ensuring timely delivery of data and integrated study reports. Arranged biweekly meetings between Genzyme team and vendors, collaborating to reduce timelines and maintain compliance with all regulations.