Experience

Avance Clinical

• Australia
• Biotechnology Research
• 100 - 200 Employee

• Manager, Study Start-up, Contracts & Budgets, Site Payments

  • Jun 2023 - Present



Syneos Health Clinical Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr Site Contracts Lead

  • Apr 2021 - Jun 2023

  • Oversees Site Contract Specialists who are negotiating clinical site budgets and contracts across multiple projects as part of a full service team. Primary focus on immunology, rare disease, and neurology therapeutic areas, and additionally cross trained on oncology and ophthalmology. • Serves as a subject matter expert on industry trends in US site budgets and contracts and contributes feasibility input on selected sites. Analyzes and utilizes current and historical data to consult on… Show more • Oversees Site Contract Specialists who are negotiating clinical site budgets and contracts across multiple projects as part of a full service team. Primary focus on immunology, rare disease, and neurology therapeutic areas, and additionally cross trained on oncology and ophthalmology. • Serves as a subject matter expert on industry trends in US site budgets and contracts and contributes feasibility input on selected sites. Analyzes and utilizes current and historical data to consult on First Patient First Visit timelines. Acts as a primary escalation point for operations teams and maintains strong communication and collaboration. • Plans contract execution strategies including forecasting execution timelines for high complexity projects. Conducts regular review meetings with Site Contract Specialists and operations teams to mentor, support, and track timelines. • Review and approval of study budgets template build for new protocols. • Works independently providing oversight of contract and budget negotiation status. Reviews of budget and contract language requests outside of Site Contract Specialists’ parameters. Determines fair market value assessment for budget requests that exceed budget parameters. Consistently meets and exceed deadlines for turnaround of budget and contract reviews ahead of department goals. • Performs quality checks of final budget and contract versions for Site Contract Specialists to ensure quality execution. • Extensive mentoring of Site Contract Specialists. • Prepares reports on risks to operations teams and contributes to meetings discussing corporate goals. • Uses strong computer skills to act as team subject matter expert on a newly implemented electronic repository system.

• Site Contracts Specialist II

  • Jun 2020 - Apr 2021

  • Negotiated clinical site budgets and contracts. Primary focus on ophthalmology, rare disease, and neurology therapeutic areas, with some oncology and immunology. • Performed analysis of site requests for contracts from initial draft templates to execution including negotiation within fallback parameters, discussion and negotiation of wording outside of fallback parameters, escalation of wording deemed reasonable to Site Contracts Lead, and conference calls with site and senior legal… Show more • Negotiated clinical site budgets and contracts. Primary focus on ophthalmology, rare disease, and neurology therapeutic areas, with some oncology and immunology. • Performed analysis of site requests for contracts from initial draft templates to execution including negotiation within fallback parameters, discussion and negotiation of wording outside of fallback parameters, escalation of wording deemed reasonable to Site Contracts Lead, and conference calls with site and senior legal when all other options were exhausted. • Performed analysis of site requests for budgets from initial draft templates to execution including negotiation within budget parameters, discussion and negotiation of budget requests outside of parameters, and escalation of budget requests deemed reasonable to Site Contracts Lead. Reviewed protocol for relevance of site requests when applicable. • Performed quality control of final contract and budget versions and archival into repository system. • Collaborated with internal and external legal contacts. Collaborated with clinical operations regarding overall site timelines, site requests impacting clinical operations, and budget requests requiring clinical input.



Accurate Clinical Research

• United States
• Research
• 1 - 100 Employee

• Vice President & COO

  • Apr 2009 - May 2020

  • Accountable for clinical operations strategy and accountable for clinical operations performance. Primary focus on rheumatology, immunology, and GI therapeutic areas. • Accountable for resource planning and allocation including training, management and reimbursement for new Investigators and clinical staff. • Feasibility review of all new protocols and training on the scientific and logistical data within them for Investigators and clinical staff. Lead startup activities in Phase 1b… Show more • Accountable for clinical operations strategy and accountable for clinical operations performance. Primary focus on rheumatology, immunology, and GI therapeutic areas. • Accountable for resource planning and allocation including training, management and reimbursement for new Investigators and clinical staff. • Feasibility review of all new protocols and training on the scientific and logistical data within them for Investigators and clinical staff. Lead startup activities in Phase 1b through 4 studies. • Acted as lead CRO/Sponsor liaison and maintained positive work relationships through direct contact with every CRO and Sponsor representative. Represented the company with vendors, physicians, and business partners. • Provided timely, accurate and complete reports on the operating condition of the company. • Spearheaded the development, communication and implementation of effective growth strategies and processes. • Extensive line management and training for clinical, regulatory, recruitment, data, and marketing personnel. Provided mentoring as a cornerstone to our career development program. • Collaborated with the management team to develop and implement plans for the operational infrastructure of systems, processes, and personnel designed to accommodate the rapid growth objectives of our organization. • Negotiated contract, budget and logistics for all outside vendor partnerships including imaging, diagnostic, and laboratory testing. • Managed risks, opportunities and issues for multiple sites across 2 states including decisions on improvements or closure. • In depth knowledge of ICH/GCP Guidelines and FDA Guidance used in the creation of SOPs and supported the development of the study specific documents. Designed training modules and wrote a 300-page training manual for site coordinators. • Oversaw site compliance activities and performed internal audits of study data for attributability, legibility, timeliness, accuracy and completion. Show less • Accountable for clinical operations strategy and accountable for clinical operations performance. Primary focus on rheumatology, immunology, and GI therapeutic areas. • Accountable for resource planning and allocation including training, management and reimbursement for new Investigators and clinical staff. • Feasibility review of all new protocols and training on the scientific and logistical data within them for Investigators and clinical staff. Lead startup activities in Phase 1b… Show more • Accountable for clinical operations strategy and accountable for clinical operations performance. Primary focus on rheumatology, immunology, and GI therapeutic areas. • Accountable for resource planning and allocation including training, management and reimbursement for new Investigators and clinical staff. • Feasibility review of all new protocols and training on the scientific and logistical data within them for Investigators and clinical staff. Lead startup activities in Phase 1b through 4 studies. • Acted as lead CRO/Sponsor liaison and maintained positive work relationships through direct contact with every CRO and Sponsor representative. Represented the company with vendors, physicians, and business partners. • Provided timely, accurate and complete reports on the operating condition of the company. • Spearheaded the development, communication and implementation of effective growth strategies and processes. • Extensive line management and training for clinical, regulatory, recruitment, data, and marketing personnel. Provided mentoring as a cornerstone to our career development program. • Collaborated with the management team to develop and implement plans for the operational infrastructure of systems, processes, and personnel designed to accommodate the rapid growth objectives of our organization. • Negotiated contract, budget and logistics for all outside vendor partnerships including imaging, diagnostic, and laboratory testing. • Managed risks, opportunities and issues for multiple sites across 2 states including decisions on improvements or closure. • In depth knowledge of ICH/GCP Guidelines and FDA Guidance used in the creation of SOPs and supported the development of the study specific documents. Designed training modules and wrote a 300-page training manual for site coordinators. • Oversaw site compliance activities and performed internal audits of study data for attributability, legibility, timeliness, accuracy and completion. Show less



Lupus Foundation of America, Inc.

• United States
• Non-profit Organizations
• 1 - 100 Employee

• Board Member

  • Jun 2013 - Jun 2016



Bay Area Habitat for Humanity-Houston, Inc.

• United States
• Non-profit Organizations
• 1 - 100 Employee

• Family Selection Committee Member

  • 2007 - 2010



Center for Clinical Studies

• Research Coordinator

  • 2007 - 2009



The University of Texas Medical Branch

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Graduate Assistant

  • 2004 - 2007



VisiGen

• Research Assistant

  • 2002 - 2003