Suzanne Bonanza Email and Phone Number

Program/Study Oversight and Leadership Competencies:• Provides strategic and operational leadership and oversight of the clinical research trial(s) to ensure delivery on time, within budget, and of high quality, in compliance with ICH/GCP, RA regulations/guidelines, and applicable SOPs.• Provides program oversight responsibilities and contributes to program strategy development, identifies and supports resolution of program issues, and helps facilitate alignment within GDO and other functions within BMS and external partners.• Provides strategic operational direction, executes complex global studies and oversees multiple cross-functional Study Teams and oversees performance and quality of the associated CRO/vendor teams.Oversees strategic planning and execution of global clinical trials to ensure timely and high-quality project deliverables. Provides leadership of the study team throughout the life cycle of the trial (start up, maintenance, and close-out). Strategically assess metrics and ensure implementation of appropriate measures as necessary to support portfolio targets/deliverables. Leads and drives collaboration with study teams and CRO partners for trial delivery to ensure meeting expected timelines, budget, and quality standards. Collaborate with key stakeholders and vendors to develop quality management strategy, plans/processes to manage risk for proactive oversight at the program level. Manage and reconcile CRO scope of work (SOW) per contract, quality, and budget. Manage vendor selection, review/approve vendor invoices, accruals and SOW changes. Evaluate clinical operational trends across studies and oversees operational logistics (e.g. vendors) at the program level. Participates in program budget review meetings and ensures that anticipated budget deviations are noted. Leads and drives collaboration with cross-functional teams such as Data Management, Pharmacovigilance, and Biostatistics, to support milestone achievement and to manage study issues.

Function as a core project team member representing clinical delivery with the customer. Current responsibilities include managing the operational aspects of global projects, from site selection through study close-out, to meet contractual requirements on time and within budget in accordance with SOPs, policies and practices; ensuring delivery of study quality and patient recruitment; driving site compliance; and leading, mentoring and training of cross-functional operational teams. Additional responsibilities include:• Lead and manage clinical delivery with customer• Collaborate with cross-functional teams to establish an integrated set of operational plans • Produce and distribute status and analytic reports to the customer, core project team, cross-functional teams, and senior management.• Ensure appropriate subject recruitment plans are in place; all outreach or digital offerings are explored and deployed in consultation with the customer. • Ensure the Recruitment Strategy Plan, patient recruitment projections and contingency plans are in place and deployed at trigger points.• Deliver assigned projects / programs according to the quality management plans.• Lead, manage and train CRAs at the project level• Manage clinical study set-up, maintenance and follow-up study activities through ongoing tracking and review of study progress. • Accountable for site selection, study quality, patient recruitment and site compliance• Develop risk management plans from a clinical perspective and coordinate clinical issue escalation and resolution

Overall responsibility and accountability for operations personnel, revenue, and quality of the North East Region. Work closely with the COO, CFO, VPs, Regional Directors, Site Directors, and Site Managers to build, manage, and lead Operations to achieve financial and study goals. Manage multiple sites and active studies across multiple therapeutic areas throughout the North East Region. Proactively identify issues that may impact enrollment and recruitment timelines. Analyze information and data to enable development of efficient and feasible delivery solutions, such as protocol feasibility, vendor selection/management, risk management, identification of new Investigator sites, patient recruitment plans, along with the assessment and management of the competitive landscape. Assume full P&L responsibility for the assigned region with revenues of $20M+ annually. Responsible for the development, preparation, and execution of the annual budget. Analyze and evaluate the activities, costs, operations, budgets and forecast data to determine progress towards stated goals and objectives. Responsibilities also include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems for a staff of 90+ total employees.

• Responsible for Phase I-IV site selection, initiation, monitoring and close out of clinical trials• Responsible for CRA assignments and allocation of resources• Develop and implement CRA training tools and presentations• Train and mentor junior/Senior CRAs including trip report review and approval• Responsible for third party vendor selection and management• Responsible for analyzing information and data to enable development of efficient and feasible delivery solutions, such as protocol feasibility and risk management, identification of new sites, optimal site distributions, patient recruitment plans• Collaborate with Quality Assurance (QA) to identify sites needing corrective and preventative action plans, responds completely and accurately to audit reports, provides team with project-specific audit process to ensure adequate preparations/reviews of all audit responses prior to submissions to QA and Sponsor• Responsible for site management and performance, including patient recruitment, subject enrollment, site relationships and data retrieval• Manage risk and contingencies proactively and lead problem solving and resolution efforts• Responsible for revenue recognition and forecasting• Work independently to identify new clinical trial opportunities from industry intelligence, follow up on leads generated from industry/therapeutic meetings, and networking with colleagues.• Manage sales cycle for RFPs, follow up on submitted proposals to secure contracts.• Develop, negotiate study budgets and contracts• Prepare monthly client contact reports and BD pipeline reports.• Assisted with capitalization, integration and set-up of entire 80 bed Phase I unit including IT, EDC, Telemetry, and trial management system• Experience with CTMS systems-Impact Harmony, eTMF, PMED, ELARA, ICOTrial, Clinical Conductor, Study Manager

Supervision, training, support and development of 15 direct reports within multiple departments and 50+ total employees.Development and revision of company policies and SOPs.Responsible for the appropriate resourcing, performance management, training and fiscal oversight for the company.Responsible for revenues of $6M+ annuallyDevelop and monitor short and long term goals of the companyDevelop new strategic relationships and partnershipsProspect and Develop new client opportunities and relationships in order to securing new business and maintain existing relationshipsConduct bid defense presentationsConduct business development planning and strategy meetingsConduct continuous process improvement efforts by identifying, analyzing and addressing process deficienciesResponsible for on time, on-budget sponsor deliverablesEstablish and maintain positive interactions/ communications with Sponsors and internal organizational departments regarding issues, project goals, and overall delivery of quality service Scheduling of assigned staff and delegation of appropriate tasks for maximum effectiveness and utilization to meet trial and departmental requirements. Conducted formal performance reviews for assigned staff, as well as establishing performance goals.Train and mentor medical staff, including physicians, coordinators, and study nurses.Identify and evaluate potential investigators.Participate in the day-to-day operations of clinical trials though the development of study plans, clinical report tracking, budgeting and investigator grant management.Negotiate and secure study budgets and contractsTherapeutic focus: CNS, Cardiovascular, Orthopedics, Pain Management, Endocrinology, Rheumatology, Gynecology, Gastroenterology, Pulmonary, Immunology, Phase I Healthy, Phase I Special population, Medical and Radiation Oncology, Podiatry, Dermatology, Vaccine, Allergy and Immunology.

Functioned as a member of Clinical Research Operations and assigned Project Teams. Developed a detailed working knowledge of all assigned protocols. Functioned as a trainer and mentor of new CRA’s. as well as, development of project specific monitoring SOPs, preparation of study manuals and feasibility assessments of potential investigators. Conducted pre-investigational site visits to assure adequacy of the site. Assisted in the final selection of investigational sites. Conducted study initiation visits to assure successful study performance. Developed a comprehensive patient recruitment strategy in conjunction with the site to assure timely enrollment. Conducted ongoing monitoring visits and closeout visits. Reviewed source documents and CRFs for each patient in compliance with Federal guidelines. Assured that FDA and other required documents are complete and properly maintained in accordance with FDA regulations. Prepared and submitted appropriate monitoring and site visit reports.

Responsible for the direction and coordination of the day-to-day operations for clinical trials with all affiliated sites. Supervise 25-member staff, which included physicians, coordinators and study nurses. Identify and evaluate potential investigators. Negotiate and secure study budgets and contracts. Participate in instruction on the organization and implementation of clinical oncology studies. Responsible for Regulatory Affairs, lab and pharmacy management, marketing and business development. Established SOP’s and study specific source documents. Affiliated with 50 physicians and 10 hospitals in Phoenix, AZ and the surrounding areas.