Manages all phases of clinical trials, ensures successful project execution from feasibility to quality closeout while maintaining timelines, budget, and compliance with regulatory standards.
• Leads and manages clinical trial projects, overseeing the implementation of study protocols, site selection and activation, patient recruitment, clinical monitoring, and study close-out activities. Ensures adherence to regulatory requirements and company standards.
• Develops and executes project plans and monitoring strategies, proactively identifying and mitigating risks through data-driven insights. Customizes system setups and tools to enhance trial management and efficiency.
• Provides leadership and specialized training to clinical teams, aligning efforts with project goals and maintaining high motivation and performance. Facilitates targeted training sessions to enhance therapeutic knowledge and project-specific competencies.
• Manages clinical budgets, collaborating with Project Leads an

Trains Investigators and Clinical Site support staff on EDC, and Protocols. Serves as primary point of contact for site staff.
• Identifies gaps at site level and resolves outstanding Protocol design questions. Plans and facilitates site meetings and key events to ensure project progress milestones are met and client goals are achieved.
• Coaches site staff on data collection and provides on-site troubleshooting support and issue resolution leading to over 30% decrease in Protocol Deviations.

• Facilitated study start-up of 4 nationwide sites on Feasibility study with enrollment of 25-34 subjects per site.
• Partnered with clinical data management to ensure site review data listings were resolved and data cleaned resulting in the Project Team meeting strict deadline of cleaning 100% of site data in a 3-month period.
• Championed study start-up and trial maintenance activities and directed Clinical sites with managing research budgets ranging from $150,000 to $300,000.

Clinical Research Site Monitor responsible for managing 5 sites across 5 clinical research studies. Performed a variety of monitoring visits and reviewed source data using a combination of 100% and reduced source data verification. Participated in 3 database locks and 1 interim analysis over a 3-year period. Used Sponsor CTMS and clinical systems (EDC, IWRS) to monitor case report forms and patient ePRO measures. Maintained randomization and drug tracking system and trained site personnel on usage of IWRS. Led sites in process of obtaining DEA approval for transfer of drug storage to satellite facilities.

• Managed and worked as TMF Expert in study start-up collection of essential documentation for 14 sites during start-up of 2 Phase III global clinical studies concurrently. Created a study tracker to track collection of all essential documentation.
• Supervised, trained, and mentored 2 clinical trial assistants in the study start-up process.

• Led patient recruitment efforts for over 50 clinical trials focused on multiple therapeutic areas leading to 20% additional revenue opportunities for Clinical Research site.
• Collaborated with Contract Research Organizations and Sponsor Stakeholders to coordinate pickup and delivery of Investigational Products achieving 100% compliance with safety standards set forth by regulatory bodies.
• Developed and implemented patient recruitment plans to ensure trial success.