• Directed the comprehensive management of a Phase II Head and Neck Cancer study, overseeing all phases from study start-up to the development of the Clinical Study Report (CSR) while ensuring adherence to regulatory standards.• Coordinated project execution and performance tracking, consistently delivering on country commitments by effectively managing all aspects of feasibility, recruitment, and study close-out.• Delivered a compelling presentation as Lead Project Manager during a critical bid defense meeting, securing a key study award from the client, which strengthened collaborative efforts and expanded project opportunities.• Supervised the execution of multiple Phase III and IV protocols for Head and Neck and Gastroesophageal cancers, enhancing site activation timelines through strategic resource planning and execution.• Cultivated strong relationships with Clinical Research Associates and Investigator Sites, significantly improving recruitment outcomes by employing targeted engagement strategies that facilitated open communication.• Established and implemented efficient project management practices that enhanced team productivity, improving the oversight of deliverables and timelines across various studies and promoting a proactive work environment.

• Championed key bid defense meetings as Lead Project Manager, successfully securing contract awards from clients and significantly expanding the organization's project portfolio.• Executed detailed analyses of project costs and personnel hours, ensuring the timely and high-quality completion of multiple clinical research studies within established budget parameters.• Delivered comprehensive risk analyses and progress updates to senior management, enabling proactive adjustments and alignment with strategic objectives for hematology and oncology initiatives.• Directed cross-functional teams comprising specialists from Clinical Monitoring, Data Management, and other critical areas, enhancing communication and overall project efficiency.

• Directed the Study Management Team (SMT) to achieve enrollment of 1,150 subjects by April 2008 in a lung cancer study, employing strategic planning and cross-departmental collaboration to exceed enrollment targets.• Managed the enrollment of 25 patients for a Phase I First in Human Ulcerative Colitis trial by December 2009, demonstrating proficiency in global clinical operations and driving team performance to meet objectives.• Developed and implemented thorough risk assessment and mitigation strategies for ongoing clinical trials, effectively minimizing delays and ensuring adherence to critical project timelines.• Managed a network of international CROs and specialty vendors, aligning efforts to meet study objectives and resulting in streamlined processes that consistently achieved project deliverables and milestones.• Delivered comprehensive presentations at global Investigator Meetings, equipping Principal Investigators and study staff with essential training on specific protocols, enhancing compliance and study execution quality.

• Attained first patient enrollment for a radioimmunotherapy study, meeting aggressive targets within three months of protocol finalization, accelerating trial progression.• Exceeded patient enrollment goals for a global collaboration study in rheumatoid arthritis ahead of schedule, demonstrating effective leadership and strong cross-functional collaboration.• Oversaw external vendor and Clinical Research Associate (CRA) activities for a Phase III radio-immunotherapy study in non-Hodgkin lymphoma (NHL), ensuring compliance with regulatory standards and enhancing operational efficiency.• Facilitated strategic meetings with Senior Management Teams (SMT) and CRAs, providing critical updates on key actions and milestones, which led to the successful implementation of corrective action plans and improved timelines.• Directed cross-departmental team activities across Europe and the United States, coordinating efforts in Medical Affairs, Medical Research, and Clinical Logistics, resulting in streamlined workflows and improved study outcomes.• Organized and presented at a study coordinator meeting for 125 participants, enhancing communication and engagement among stakeholders for the rheumatoid arthritis trial, while also playing a pivotal role in planning the diffuse large B-cell lymphoma investigator meeting.

• Conducted thorough on-site initiation, monitoring, and termination visits for a Phase II NHL study, ensuring adherence to regulatory guidelines and improving data accuracy across all participating sites.• Identified and established relationships with new Investigators for a Phase III lung cancer study, enhancing recruitment efforts and expanding the study's reach within the research community.• Contributed to the development and refinement of oncology study protocols and case report forms (CRFs), which facilitated clearer documentation and streamlined the data collection process.• Actively participated in the clinical SOP committee, helping to create and implement standard operating procedures that improved operational efficiency and enhanced training processes for new team members.• Supported the preparation of study budgets and the management of grant disbursement payments, ensuring effective resource allocation and compliance with financial regulations throughout the study lifecycle.

• Directed on-site monitoring visits for various clinical trials, ensuring strict compliance with regulatory standards and maintaining the integrity of studies related to rheumatoid arthritis and Alzheimer’s disease.• Led the development of essential project tools, including correspondence templates and source document verification worksheets, resulting in streamlined processes and enhanced documentation accuracy for Phase I, II, and III studies.• Facilitated training sessions on clinical supply management at Investigator Meetings, elevating knowledge and compliance among study site personnel and positively impacting trial execution.• Supervised team members by reviewing trip reports and providing constructive feedback, which improved overall team performance and ensured adherence to study protocols.• Monitored clinical trials for multiple indications, ensuring study centers complied with protocol, FDA regulations, and ICH/GCP guidelines, thus safeguarding participant safety and data integrity.