• Collaborates with Executive Board on business plan for Clinical Operations Department and overall company development for streamline organizational footprint• Instituted and facilitated partnership with IT services to ensure proper safeguards and consistencies amongst the company’s employees related to software and portals (Shared Space)• Created and implemented Clinical Operation Department SOPs, forms, templates, and presentations• Assisted with the creation of other business development materials including those for use at conferences; attended conferences to represent Clinical Operations Department and discuss capabilities of Primera CRO services• Attends and leads discussions for new business opportunities with Sponsor representatives• Works strategically with Director of Budgets and Contracts for Sponsor Request for Proposals, Change Orders for updates to Scope of Work and Study/ Site budgets• Oversees Clinical Operations Study Teams to ensure timely and quality executions of Clinical Studies

• Study Management and oversight of clinical study operations and supplier management• Driver for overall budget, timelines, and scope of work through implementation of streamlined processes with clear, concise and organized plans• Contributed in the writing of clinical documents including study protocols, investigator’s brochures, study manuals and plans, and clinical study reports• Led the Clinical Study Team and Cross-functional Team to make key decisions related to strategy and issue resolution with a risk mitigation mindset• Successful implementation of a targeted monitoring and risk-based quality management approach to clinical trials• Multi-CRO (large and smaller in country CROs) oversight with ability to consistently operationalize activities across the study• Proactive risk evaluation, mitigation, and implementation to minimize shifts in timelines, budget, and resources• Demonstrated agile strategic planning and rollout of mid-study change in monitoring schema from full SDV to Risk Based Monitoring/reduced SDV• Collaborated on several initiatives focused on Diversity and Inclusion, as well as, reimagining how to work in the age of COVID-19/full remote working• Oversaw the implementation of a new study-specific training, created cross-functional training matrix, and worked closely with Quality Assurance to create tools and process for disseminating and tracking training across the company

• Globally managed operational aspects of study activities• Demonstrated ability to conduct sponsor and vendor management operations• Demonstrated advanced knowledge of interaction within multi-functional teams• Independently and proactively provided solutions to challenging issues to the satisfaction of the sponsor and PRA management• Implemented risk management strategies• Assisted in rapid start-up of COVID-19 early access study; worked directly with sponsor representative to oversee and manage the entry of all study sites; fully managed the dispensation of all IP to study sites • Revamped CTM management on global study to focus on a single point of contact allowing the team to gain efficiencies in study activities• Mentored junior level staff• Act as coordinating CTM to ensure consistency of training, processes, and systems related practices as well as ad -hoc coordinating activities

Manages and monitors sites with regard to Phase I-IV Clinical Trials, while adhering to Sponsor approved monitoring plans, FDA regulations and ICH GCP guidelines. Reports study related information directly to Project Leaders and Lead CRAs, as well as, SAE submission.

Assisted various department members with clinical administrative tasks; gained insight and increased knowledge related to clinical trials and the clinical trial industry.