Freelance Clinical Project Manager

9/2021 – 2/2025

Global Project Manager overseeing the Phase 1 Clinical Study in multiple countries.
Responsible Tasks:
• Acting as primary point of contact for vendors, investigational sites and cross functional
teams and escalates to the study lead as necessary
• Managing clinical monitoring activities and the overall site management ensuring
compliance with Good Clinical Practice (GCP) and applicable regulations and tracks site
performance metrics
• Oversight of IRB submissions
• Creation of annotated reports
• Manage and oversee the project timelines
• Perform ongoing sponsor oversight of all contracted services, including review and
updating of study plans and key documents and oversee risk management and monitoring
activities. Ensure documentation of oversight activities accordingly.
• TMF review and QC
• Protocol deviation reviews and reporting
• Trained staff on Quality and Study
• Overall responsibility of study as Global Project Manager
• Conduct review of Protocol Deviations and catagories. Preperation of Agenda and
minutes. Lead Glocal Protocol Deviation Call
• Oversee CA, LEC and EC submissions
• Audits
• Medical Scientific Liaison
• Risk Management Study Plans
• Lead Project Meetings
• Lead Protocol Deviation Meeting, agenda and minutes
• Overall Study Tracking

Klinische Forschung

8/2018 – 2/2020

Senior Clinical Project Manager

Klinische Forschung

3/2015 – 4/2016

• Attendance at project team meetings
• Liaison with clients and investigators to ensure efficient
• Co-ordination of Clinical Monitoring Team
• Team Management in 18 Countries
• Attendance at project team meetings

Klinische Forschung