Justin Stark Email & Phone Number

Job Purpose:Accountable for defining strategic plan and driving strategic projects for the Trial Monitoring function. Accountable for fostering innovation and driving innovation objectives for Trial Monitoring. Accountable for ideating, establishing and driving advanced data-driven methodologies and practices to substantially enhance the practice and delivery of clinical trial monitoring. Major Accountabilities:• Drive successful execution of key strategic projects within Trial Monitoring in line with short-, medium- and long-term strategies• Track and review progress of all initiatives in Trial Monitoring and ensure they embed and support strategic imperatives as required• Drive participation of Trial Monitoring in key strategic enterprise-wide programs and implementation within Trial Monitoring• Together with the Head of Trial Monitoring Excellence, lead global initiatives to increase efficiency and productivity of Trial Monitoring organization; engage the organization to ensure adoption of change that drives continuous improvement• Lead Innovation in Trial Monitoring; explore and evaluate innovative solutions to improve monitoring in support of global development goals• Lead/co-lead creation and deployment of data-driven innovations to business model that result in step-change in monitoring processes and practices with significant enhancements to efficiency and productivity• Serve as monitoring champion for cross-functional initiatives and innovations that involve Trial Monitoring• Drive adoption of innovative solutions in collaboration with Regions and countries• Co-lead creation of central/Risk Based Monitoring methodologies and approaches. • Ensure awareness of trends in the industry in the field of innovation in monitoring; engage Trial Monitoring leadership teams in activities as required• Analyze external benchmarking and trends (e.g. CenterWatch) to determine best-in-class approach and propose corresponding improvements for Trial Monitoring

Facilitate the awareness and adoption of Risk-Based Monitoring (RBM) via publications, industry presentations, sharing of best practices and lessons learned amongst TransCelerate member companies and the review/maintenance of RBM initiative assets.

Raleigh-Durham, North Carolina Area

Lead the development, pilot and implementation of risk-based methodologies, capabilities and associated sponsor oversight practices to enable risk-based management of clinical studies at UCB. Key responsibilities include:- Be the lead for establishing and embedding a meaningful and sustainable culture of RBM within GCSO.- Work with individual organizations within GCSO to develop a cohesive and effective team comprised of all the required skill sets to build RBM capability.- Develop robust data analytics life cycle strategy for RBM starting from defining the risk, identifying and triaging signals and managing risks/issues to resolution.- Provide inputs and guidance to the RBM team in the development and finalization of the risk assessment categorization tool (RACT) that will cater to UCB indications and studies.- Coach and mentor the RBM team on the concept of risk management and the methodologies within RBM.- Work with SPI partners to ensure timely availability of CDISC data and other data sources.- Ensure cooperation with the SPI partners and the individual functions within GCSO to embed RBM within each clinical study.- Collaborate with Clinical Quality Assurance and Advanced Analytics to develop robust analytical techniques that can help detect data anomalies and the early identification of at-risk sites.- Collaborate with IT in identifying RBM technology requirements and solutions for the successful implementation of RBM.- Liaise with TransCelerate work stream members from other companies and contribute to the future of RBM by bringing in novel techniques (e.g., machine learning) to and from TransCelerate.- Interact with external organizations to generate insights on how competitors are leveraging RBM for their competitive advantage.- Collaborate with the site selection group to share insights and metrics generated from RBM.

Raleigh-Durham, North Carolina Area

- Architected key cross-functional processes of company’s risk-based monitoring clinical development model in collaboration with subject matter experts. - Oversaw development of prototype tools and defined requirements for development of successor technology platform to enable centralized data and operational surveillance (CDOS) delivery processes.Held various roles of increasing responsibility including:Director, Product Development, 2011 - 2013- Collaborated with key customers to design, pilot and implement new service delivery partnership models. Led major initiative with a key customer, from concept to implementation, of a captive centralized, risk-based monitoring solution.- Identified and oversaw implementation of quality control processes and tools resulting in significant improvement in quality of delivery processes within an existing data management unit.- Designed and managed development of semi-automated operational business intelligence dashboard to improve capabilities of unit to manage service delivery. Associate Business Intelligence Director, 2010 - 2011- Led team to conduct delivery assessment for the portfolio of an at risk captive delivery unit and identified delivery risks. Recommended and monitored implementation of actions to mitigate these risks and improve future performance.- Developed an integrated portfolio and study level scorecard to provide a consistent, transparent, data-driven representation of current study status with associated data collection tools and data validation controls.Business Analyst Lead, 2009 - 2010- Facilitated subject matter expert process reviews, documented processes and reviewed with senior executives and designees to establish enterprise end-to-end study delivery process model.

 Created new business development strategy as part of a multi-disciplinary team focusing on corporate clientsand presented plan to senior leadership of the firm. Analyzed capital structure of 29 industries to identify and prioritize sectors with the most promising prospects. Quantified potential market size of industries and modeled 3-year revenue forecast for team. Modeled potential financial impact of various hedging strategies and prepared presentations for clients coveringcurrent market environment, peer analysis, and best interest rate hedging strategies.

 Led three Black Belt improvement projects focused on improving customer satisfaction (8% improvement incustomer satisfaction and 33% reduction in lost business), increasing entitled revenue recognition ($600,000increase in realized profits), and improving performance metrics in FY’06. Trained 185 front-line managers and supervisors as Green Belts. Managed and sustained Six Sigma initiative through group and location Executive Steering Committees,mentorship of 18 completed Green Belt projects, and implementation of 160 known solutions. Recognized as one of the top ten Black Belts in division, received the Northern Group Award for “ExcellentContribution to Operational Results” and appointed to Management Certification Board (2006).Prior to serving in the Black Belt role I had successful stints as a sales representative, production supervisor, office manager and collection supervisor with the firm. Joined firm through rotational management trainee program in 2002.

Mba, Investment Finance/Corporate Finance

Activities and Societies: Academic Fellow for Financial Accounting, Executive Fellow, member of Finance Club, Asset Management Club.

Education record