Courtney Brant-Sharpler

Responsible for strategic operational and leadership oversight of global clinical studies within a program covering all clinical deliverables and operations to scope, quality, budget, time, resource, and risk, ensuring integration of strategy, design, feasibility, and operational planning to produce business-focused clinical drug development programs that align with priorities and strategy.

• Led operational planning and strategy for global clinical oncology Phases II and III trials, ensuring quality, budget, and resource management while innovating design and delivery models.
• Directed global resource allocation in the department according to project priorities.
• Implemented streamlined portfolio reporting procedures to enhance transparency and accountability in global clinical operations.
• Develops core clinical operations components for governance interactions
• In collaboration with leadership, I facilitated demand planning and utilization across all programs within Late Stage Oncology.
• Delivered clinical operations guidance for country selection, feasibility, and risk management using innovative models.
• Supplied expert analysis on clinical operations for the development of new business cases focusing on cost efficiency, adherence to timelines, quality standards compliance, feasibility studies results and potential risks.
• Actively participates in networking, both within and outside the therapeutic area, sharing best practices and lessons learned.
• Provides project leadership for cross-functional clinical teams in the delivery of clinical program team activities, including support of regulatory market applications and post-registration product maintenance deliverables.
• Mentored, coached and supported team development.
• Early adopter of new ways of working, acting as an ambassador for change, and driving the implementation and utilization of new initiatives.
• Lead the process to identify and solve or escalate operational issues, and drive delivery to plan through internal or external partners for outsourced studies (Alliance partners, Clinical Research Organizations (CROs), vendors, and Academic Research Organizations (AROs)).

• Led FSP Solutions from client discussions to RFI, RFP, and bid defense meetings, working closely with sales and operations.
• Provided insights and strategy for customer solutions based on understood requirements across functions.
• Served as the key contact for strategic planning, direction, and execution of new clinical FSP business.
• Managed overall strategy design, including recruiting strategy and model ramp delivery.
• Led the articulation and definition of the FSP model, including its governance, while working closely with operations.
• Prepared text and budget for proposals, rebids, and related documents.
• Collaborated with internal stakeholders to create and finalize project budgets and scope of work to meet financial and company goals, realizing margin targets and proactively ensuring adherence to processes.
• Collaborated with the operational regional heads, model alliance leads, or account teams on their ongoing client discussions to identify expansion opportunities and the evolution of the current model.

• Primary oversight of global FSP accounts in Oncology, leading resource management, as well as serving as a senior scientist for feasibility and patient recruitment in Oncology clinical trials within the Innovative Strategies therapeutic area.
• Responsible for the operational, global oversight of client accounts within our Functional Service Provider (FSP) department.
• Responsible for assessing client needs and resources, and providing solutions for both Syneos Health and the client.
• Performed high-level analysis of data informatics and competitive intelligence for accurate forecasting and benchmarking in clinical research start-ups, to aid in protocol design optimization, country, and site identification.
• Coordinated complex international projects and adapted to shifting priorities with ease, reflecting a strong ability to manage multiple priorities.
• Collaborate with internal experts to understand the patient journey, and enhance communication strategies.
• Identify and engage with third-party vendors to enhance access to diverse patient databases
• Develop and implement community outreach plans, fostering trust and engagement among diverse populations.
• Track campaign effectiveness, spending, and ROI, providing insights, and qualitative feedback to leadership.
• Developed quarterly forecasts and was responsible for overseeing and maintaining the account budget.
• Management of the account financials, with the study budget including invoicing, revenue recognition, and payment schedule adherence across multiple POs.
• Provided leadership, hired, and onboarded to a team of over 30 across oncology, primary care, neurology, vaccination development, and infectious disease clinical research programs
• Ensured our team continuously meet or succeeded the financial metrics established for governance and identified mitigations as necessary

• Provided oversight for North America operations and senior scientist support for client accounts, specializing in patient recruitment and feasibility across oncology clinical trials.
• Lead a team in developing and implementing strategies to meet patient recruitment and enrollment goals
• Utilized KPI tracking to identify trends and inform strategy, leading to an increase in ROI.
• Conducted high-level analysis of data informatics for study start-up forecasts, benchmarking assumptions, and enrollment plans.
• Protocol design optimization, country, and site identification.
• Develop high-level study plans and strategies that contribute to overall protocol development in order to measure ROI.
• Responsible for expanding the account by more than 50%.
• Developed quarterly forecasts and was responsible for overseeing and maintaining the account budget.
• Management of the account financials, with the study budget including invoicing, revenue recognition, and payment schedule adherence across multiple POs.
• Provided leadership, hired, and onboarded project managers, data analysts, and feasibility, and patient recruitment and retention specialists.

• Responsible for the planning and executing operational aspects of clinical research programs from study start up to completion among Phases I-IV through cooperative, industry, and investigator-initiated gastrointestinal malignancies, aero-digestive, and solid tumor oncology trials
• Managed deliverables, timelines, oversight of project costs, contracts and agreements
• Development of direct reports through mentoring, career path management and delegation of responsibilities
• Managed the workflow for over 40 oncology clinical trials
• Leveraged tracking systems in the management of complex cross-functional clinical projects, ensuring timely completion and compliance with regulatory requirements
• Attended tumor board meetings and presented potential patients for corresponding research studies
• Developed informed consents for PI Initiated oncology trials
• Managed adherence to regulatory requirements in multiple international clinical trials, ensuring the safety and ethics of patient treatments

• Oversight of data management, project feasibility and start-up of all new trials on the solid tumor docket, including coordination of clinical trials pertaining to all solid tumors
• Development of direct reports through mentoring, career path management and delegation of responsibilities
• Lead multidisciplinary group team with members consisting of medical oncologists, surgeons, radiation oncologists to discussing appropriate patient trial participation
• Led a cross-functional team in advanced data monitoring activities, significantly reducing errors and discrepancies in program data
• Developed department wide standardized to ensure consistency and accuracy across the department
• Participated in the integration of innovative medical systems and clinical trial data management systems, OnCore into existing operational structures to improve efficiency and accuracy

• Company Overview: The Children's Hospital of Philadelphia is a leading pediatric healthcare provider, known for its innovative research and comprehensive care
• Interim department oversight after 3 months employed
• Sole research coordinator for over 35 pediatric phase I oncology clinical trials, with 10 active patients simultaneously receiving treatment
• Responsible for maintaining all regulatory related tasks along with data collection and management
• The Children's Hospital of Philadelphia is a leading pediatric healthcare provider, known for its innovative research and comprehensive care

• Responsible for recruitment and enrollment of 500 parent/teen dyads for a large grant funded study about novice drivers
• Assisted in the development of manuscripts, protocol development and driving assessments
• Worked with the PI on development of driving simulation research studies
• Ensured database integrity through precise data entry.