Well-versed in building positive relationships with customers and other stakeholders. Skilled at overseeing complex, high-value technical projects with excellent planning competencies. Line management experience in both Europe and North America.
Overview
13
13
years of professional experience
Work History
Clinical Project Delivery Manager
Fortrea (Formerly Labcorp)
04.2021 - Current
Implemented Key Quality Indicator tracker trending metrics in 3M, 6M and 12M intervals
Decreased clinical team turnover within sponsor portfolio from >25% to
Served as escalation point for clinical project issues, within area of project responsibility, to internal and external stakeholders, as appropriate
Communicated project updates to stakeholders at all levels
Responsible for clinical project delivery with regards to agreed time, scope, cost and quality
Ensured clinical project team is resourced effectively
Proactively led both quality control and risk assurance activities to ensure clinical project deliverables were met according to regulatory, organization and client requirements
Served as key client contact for assigned project responsibilities, establishing working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business
Proactively identified and resolved conflicts as needed
Understood clinical project delivery strategy, costing assumptions and resulting budget for assigned project(s)
Monitored clinical project scope, schedule and costs to ensure all remain on track with contract and with financial performance targets
Clinical Team Lead
Labcorp
06.2019 - 03.2021
Responsible for clinical project delivery with regards to agreed time, scope, cost and quality
Key clinical deliverables included but were not limited to: patient recruitment and retention
Ensured clinical project team was resourced effectively
Agile management of Monitoring Visit Strategy
Management of clinical deliverables related to protocol endpoints
Supported/Led Clinical project team ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders
Served as escalation point for clinical project issues, within area of project responsibility, to internal and external stakeholders, as appropriate
Served as key client contact for assigned project responsibilities
Established working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business
Proactively identified and resolved conflicts as needed
Senior Clinical Research Associate
Labcorp
06.2018 - 05.2019
Implemented and monitored clinical trials to ensure sponsor and investigator obligations were being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
Provided regular site status information to team members, trial management, and updated trial management tools
Reviewed and verified accuracy of clinical trial data collected, either onsite or remotely
Performed essential document site file reconciliation
Mentored junior level CRAs
Clinical Research Associate II
PRA Health Sciences
01.2015 - 06.2018
Implemented and monitored clinical trials to ensure sponsor and investigator obligations were met and were compliant with applicable local regulatory requirements and ICH-GCP guidelines
Conducted pre-study, initiation, interim and close out monitoring visits as applicable
Provided regular site status information to team members, trial management, and updated trial management tools
Completed monitoring activity documents as required
Worked closely with other clinical team members to facilitate timely resolution of issues
Performed essential document site file reconciliation
Performed source document verification and query resolution
Assessed IP accountability, dispensation, and compliance at investigative sites
Verified Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
Mentored junior level CRAs
Clinical Research Associate II
Theorem Clinical Research
07.2014 - 01.2015
Coordinated and performed comprehensive site management, including Investigator Site File/Trial Master File maintenance and site correspondence
Conducted pre-study, initiation, interim and close out monitoring visits
Produced comprehensive visit, status and telephone contact reports
Resolved data issues and audit issues
Mentored less experienced CRAs
Clinical Research Associate I
Theorem Clinical Research
07.2012 - 07.2014
Coordinated and performed comprehensive site management, including Investigator Site File/Trial Master File maintenance and site correspondence
Conducted pre-study, initiation, interim and close out monitoring visits
Produced comprehensive visit, status and telephone contact reports
Resolved data issues and audit issues
Safety Data Coordinator
Novo Nordisk
03.2010 - 07.2012
Triage leader responsible for overseeing both product registration and post-marketing drug safety development teams
Supported Novo Nordisk internal post-marketing communication and education
Processed case documents in electronic data capture (EDC)
Acted as primary trainer for new team members, focusing on standard operating procedures, best practices and development and support of documentation
Co-owner of SOP maintenance and supportive guidelines
Managed post-marketing patient recall program for Vagifem 25mcg
Therapeutic Experience
Endocrinology Diabetes Diabetes
Obstetrics/Gynecology Women's Health Menopause
Education
Bachelor of Business Administration - Human Resource Management
Executive Director, Project Finance at FORTREA (formerly Labcorp Drug Development)Executive Director, Project Finance at FORTREA (formerly Labcorp Drug Development)
Associate Manager, Medical Data Review at Fortrea (Formerly Labcorp), BengaluruAssociate Manager, Medical Data Review at Fortrea (Formerly Labcorp), Bengaluru