Experience

Miltenyi Biomedicine

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Trial Manager

  • Oct 2023 - Present



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Clinical Trial Manager

  • Oct 2022 - Oct 2023

  • Providing high level country strategy and actively drive study progress and local/country level study delivery in liaison with global and local country teams. • Planning, managing, and overseeing the clinical study implementation in accordance with the global program strategy. • Reporting country status incl. timelines and results to key partners and updating status in relevant systems. • Ensuring local delivery of the study by partnering with relevant key stakeholders and providing ongoing country level input into the Country Operational Plan. • Supporting internal audits and inspection activities as well as contributing to CAPAs. • Developed strategies to achieve 90% database clean for a global oncology study as against 15% anticipated by interim analysis deadline. • Designed and trained study team on project tracking tools and system reports that increased site and study team efficiency in resolution of data issues. Show less



ICON plc

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Trial Manager

  • Nov 2021 - Aug 2022

  • Functional Lead and Project Management Associate from Clinical Research Services heading the delivery of all clinical aspects of clinical studies (metabolic health, rare diseases, opioid addiction). • Executed and oversaw central activities from planning, trial start up, through the life of trial to close-out in liaison with the Global Trial Lead. • Headed clinical team to ensure quality, timelines, and budget management. • Oversaw the financial performance and managed all project deliverables for assigned projects and/or project regions. • Managed and tracked key study metrics to ensure adherence to project milestones, along with cross-departmental communication. • Managing trials on 3 global studies with over 90 sites and dozens of vendors and systems simultaneously. Also, managing over 20+ CRAs as direct reports. • Ensured that study team stayed within approved budget despite a lot of unforeseen circumstances. • Assigned all study support staff and ensured that all required trainings are completed within the allowed timelines. • Ensued the availability of robust recruitment / contingency plans are in place for each region. Show less



ICON GPHS

• United States

• Senior Clinical Research Associate

  • Nov 2020 - May 2021

  • Managed two sites with 600 combined subjects and was able to review and verify all data ahead of interim analysis despite travel restrictions due to COVID. • Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment and understanding of study requirements. • Reviewed and verified eCRFs and other clinical data for completeness and accuracy and generate queries. • Documented each visit with a quality written monitoring visit report, submitted within expected timeframe and made sure follow up letters were sent to investigator sites. • Provided guidance to more junior CRAs in how to manage their interactions with Client personnel. • Recruited investigators for participation in assigned study. • Updated project tracking systems with subject and site information. Show less



PPD

• United States
• Research Services
• 700 & Above Employee

• Senior Clinical Research Associate

  • Nov 2019 - May 2020

  • Onsite and remote monitoring visits for all assigned sites for Phase II studies (Endocrinology and Cardiometabolic). • Site management for multiple sites in a four-protocol study. • Assisted Clinical Trial Managers managing assigned tasks. • Provided enrollment support and ensured progress by troubleshooting startup and recruitment issues from investigators and site staff while partnering with study team to support recruitment efforts at site and country level • Worked with and cleaned up multiple at-risk sites ensuring they are all audit ready. Show less



Syneos Health Clinical Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Clinical Research Associate/Clinical Study Manager

  • 2016 - Nov 2019

  Continued in previous position in the same company which changed name and structure. • Worked on multiple indications and protocols simultaneously (Endocrinology and Dermatology). • Assisted with study start up, activation, and execution for targeted sites. • Developed study specific tools for tracking and reporting for clinical team and for the client. • Generated study specific plans incl. Project Plan, Monitoring Plan, Communication Plan and other required plans. • Supported the project management with assessment of workload and site assignment within the project team. • Performed several quality assurance and evaluation visits for several junior CRAs. • Participated in formulation of CAPA for audit findings and ensured that all affected sites carry out CAPA and document CAPA training. Show less



inVentiv Health Clinical

• United States
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Senior Clinical Research Associate/Clinical Study Manager

  • Jan 2016 - Jan 2018



inVentiv Health

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• CRA II

  • 2015 - 2016



inVentiv Health Clinical

• United States
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• CRA 1

  • 2014 - 2015