Client Services Lead

• Mar 2022 - Present

Senior Project Manager

• Jul 2021 - Mar 2022

Clinical Project Manager

• Jul 2019 - Jun 2021

Associate Project Manager

• Sep 2017 - Jun 2019

Clinical Research Associate III

• Apr 2015 - Sep 2017

• Direct and prioritize clinical operations team efforts for large, complex Phase III Cardiovascular studies and programs • Assess overall team progress against study timelines and metrics. • Mitigate areas of risk related to data currency, site performance, and retention and recommends improvements to Project Leader. Oversee the implementation of Corrective Action Plans for research sites with compliance issue. • Work closely with Data Management on strategies to resolve complex… Show more • Direct and prioritize clinical operations team efforts for large, complex Phase III Cardiovascular studies and programs • Assess overall team progress against study timelines and metrics. • Mitigate areas of risk related to data currency, site performance, and retention and recommends improvements to Project Leader. Oversee the implementation of Corrective Action Plans for research sites with compliance issue. • Work closely with Data Management on strategies to resolve complex issues to ensure data collection and cleaning are complete and benchmarks/timelines for completion are maintained. • Maintain effective communication with Sponsor and other functional groups on retention related topics through regular correspondence and weekly metrics reports. • Lead weekly Retention Sub Group meeting composed of Sponsor, external CRO, and academic partner representatives to develop and implement strategies to improve trial retention. • Successfully lead Retention Sub Group to reduce patients with missing vital status from 5% to 1.2% over a 6 month period during study close out. • Compose CTMS data entry guidelines and review CTMS metrics/reports to ensure regulatory compliance. • Create training materials on data management, retention, and close out topics and conduct global training for over 60 CRAs and 600 sites. • Work closely with Finance department on complex site payment issues. Negotiate and process site contracts and budgets and provides guidance for less experienced team members. • Oversee cross functional work of Outcomes, Data Management and Clinical Operations groups on specific project deliverables. Compose project process for data collection from closed sites. • Manage and oversee the work of 4 CRA I/II level employees, including providing input for performance evaluations and assisting with implementation of corrective action where needed. • Trial Experience: EXSCEL 14,752 patients enrolled globally across 688 sites and 35 countries.

Clinical Research Associate II

• Jun 2013 - Mar 2015

• Performed routine and complex on-site and in-house site assessments for clinical trials for over 50 clinical sites. • Followed up, resolved, documented, and report on complex issues identified during risk monitoring and assessment activities. Implemented and worked with sites on correction action plans to address compliance issues. • Acted as the primary clinical contact for the study site and guided the site through patient enrollment and study procedures. Worked closely with study… Show more • Performed routine and complex on-site and in-house site assessments for clinical trials for over 50 clinical sites. • Followed up, resolved, documented, and report on complex issues identified during risk monitoring and assessment activities. Implemented and worked with sites on correction action plans to address compliance issues. • Acted as the primary clinical contact for the study site and guided the site through patient enrollment and study procedures. Worked closely with study sites to complete study start up by facilitating site regulatory approval. • Trained site physicians and clinical research coordinators on study protocols and procedures. • Negotiated and processed site contracts and budgets and provided guidance for less experienced team members. • Used critical thinking skills to monitor sites’ compliance with protocols, data collection and cleaning requirements, and regulatory guidelines. • Reviewed and approved site specific Informed Consent Form templates. • Worked with sites to ensure data collection and cleaning were complete and benchmarks/timelines for completion were maintained. Including resolving data queries and collection of source documents to support end point adjudication. • Managed and provided oversight to the work of 2 CRA I’s including providing input for performance evaluations and assisting with implementation of corrective action where needed. • Trial Experience: EXSCEL 14,752 patients enrolled globally across 688 sites and 35 countries, TECOS 14,757 patients enrolled globally across 450 sites and 35 countries.

Manager - Site Start Up

• Sep 2011 - Jun 2013

• Co-managed a team of 22 Site Start Up Specialists including training, resourcing, and ensuring work is in compliance with applicable regulations and SOPs. • Supervised teams and collaborated with sponsors to resolve complex study start up issues. Determined resource forecasting across 5-7 protocols. • Managed and developed 7 direct reports, including annual performance evaluations and ongoing performance. • Developed and monitored processes for review of site contract and regulatory… Show more • Co-managed a team of 22 Site Start Up Specialists including training, resourcing, and ensuring work is in compliance with applicable regulations and SOPs. • Supervised teams and collaborated with sponsors to resolve complex study start up issues. Determined resource forecasting across 5-7 protocols. • Managed and developed 7 direct reports, including annual performance evaluations and ongoing performance. • Developed and monitored processes for review of site contract and regulatory documents. Led a quarterly Site Start Up/Contracts management meeting on process improvements.

Site Start Up Specialist II

• Sep 2010 - Sep 2011

Regulatory Submission, negotiate and review contracts

Clinical Research Coordinator

• Sep 2003 - Aug 2010

Clinical Research Coordinator, Obesity Clinical Trials Program Clinical Research Coordinator, Obesity Clinical Trials Program