→ Global Clinical Operations Lead and North America Regional Head for Early Clinical Development.→ Key Alliance-level representative for Clinical Operations providing single-point of contact for functional area responsible for resourcing, quality, & consistency of service.→ Managed departmental financial, commercial, quality, talent management, & strategic objectives of service in alignment with business unit objectives.→ Represented Clinical Operations with proposal and costing model, RFP, RFI, & bid defenses.→ Directed resourcing strategy and delivery.Key Achievements:→ Managed 130 staff (~15 M in salary) and contributed to 10 M/Mo. in revenue, with Operating Margin of 47%.→ Clinical Operations Governance Alliance leader to several strategic accounts including one which experienced 73% growth in project award and TA expansion.→ Global Clinical Operations Integration Lead (Chiltern + Covance) for resource management, system and metrics, & talent management.→ During 4 year period, increased overall headcount by 67%, visit productivity by 116%, & lowered the cost per FTE by 5% while maintaining 86% staff retention rate.

→ Oversaw Clinical Operations North America region Early Clinical Development team.→ Performed detailed performance reviews and management of assigned direct reports including: annual Performance Management and Development (PMD), Individual Development Plan (IDP), & Line of Sight Goals.→ Managed and provided resolution for performance issues→ Developed and measured performance indicators for assigned staff within Clinical Operations.→ Identified individual training needs and assisted with the coordination and conduct of training and development efforts on a global scale.→ Prioritized and coordinated global training initiatives to ensure compliance with policies and procedures.→ Ensured compliance with management strategies, policies, & procedures in conjunction with leadership teamsKey Achievements:→ Drove sustained monitoring quality indicators to 98% exceeding all KPI targets.→ Risk-Based Monitoring work-stream process and document developer.→ Executive sponsor for new-to-role, clinical program, Oncology Monitoring Excellence Academy, & Alliance Relationship Managers→ ACRP joint task force co-lead for Harmonized Core Competencies for Clinical Monitors.→ Partnered with recruiters to develop sourcing targets and process enhancements that cut time-to-fill in half while enhancing quality checks to prevent fraudulent candidates.

→ Maintained direct line management Clinical Team Managers.→ Oversaw and developed employees to ensure fulfillment of their responsibilities in accordance with policies, procedures, SOPs, & regulatory requirements.→ Managed operational budget and employee resources within respective budget guidelines and developed budgets for specifics programs.→ Supported central proposals for project bids, attended bid defense meetings, & implemented clinical operations productivity, process, & quality improvements.→ Assessed clinical operations employee resources and employee resource projections to ensure that project teams met client expectations and contractual obligations.Key Achievements:→ Led the development of the Clinical Team Manager (CTM) role for ~300 employees including developing training, KPI management, study specific governance reviews, staff performance management, & peer-based mentoring.→ Served as Clinical Operations Alliance member for strategic accounts deemed at high risk and authored cross functional CAPAs resulting in enhanced customer satisfaction.→ Contributing author to the annual Clinical Operations Business Plan.

→ Maintained Direct line management of Regional CRAs and Clinical Leads.→ Determined level and type of employee resources to meet corporate/client/project objectives.→ Scheduled and reviewed project tasks, while providing leadership in the delivery of KPIs and services to clients.→ Ensured staff fulfilled their responsibilities in accordance with policies, procedures, SOPs, ICH GCPs, & country-specific regulatory requirements.→ Recommend and implement clinical operations performance and productivity improvements to optimize utilization of billable staff.→ Identified and implemented process improvements to optimize employee performance.→ Participated in quality efforts for continuous improvement by assuring metrics were aligned with company, client, & clinical operations objectives.Key Achievements:→ Departmental SME and courseware training developer for CTMS and eTMF - departmental lead for VOIP implementation.→ Innovation competition winner.

→ Implemented and monitored clinical trials to ensure compliance with applicable local regulatory requirements and ICH guidelines. → Qualified potential investigative sites, initiated studies, ensured drug accountability, data integrity, & regulatory compliance.

→ Developed and implemented clinical program including negotiating CRO, central lab, central imaging, CRA consultants, & investigator contracts and budgets across three indications.→ Participated in protocol development and directed protocol implementation including vendor qualification, CRF development, data management, & clinical management plan.→ Direct line-management of clinical staff including Project Managers and Data Managers, CRO and contract regional monitors.→ Led SOP development and ICH/GCP training.→ Presented clinical program status to the Board of Directors.

→ Drafted, reviewed, negotiated, & managed institution's oncology clinical trial contracts and budgets on behalf of the Regents.

→ Developed and executed Site Management Organization (SMO) management model/business plan and strategy including expanded TA offerings, exclusive service agreements with Managed Care Organizations, & office expansion. → Served as an operational head.→ Reviewed and negotiated investigator contracts and grants and oversaw investigator reimbursement.

→ Managed clinical research staff and assigned to studies, trained investigators on research protocols, audited research CRFs and critical document binders, & negotiated investigator contracts and budgets.

→ Recruited and enrolled research subjects for a variety of investigative protocols, completed source documents and CRFs, collected laboratory specimens, & dispensed study medication.