Ine Beunen

Bayer employee/insourced

• Manage/ lead/coach CLM's, CRA's and CTA's (insourced/ internal) in executing Phase I-IV trials.
• Quality oversight/ ensure Site Management (SM) activities are in line with legal, regulatory and compliance expectations
• Ensure country targets are met
• 8-12 reports

Accomplishments:

- Establish ECCRT (European Centre of Clinical Research training) trainee internship

-Promoter of thesis student of KUL and supervisor of trainee at SM department

- Supervise and assure organization of study coordinator event

-#Wow practitioner: roll-out of agile way of working in BeneLux.

- Active member of Expert working groups within SM Europe

- Member of greenhouse initiative: Launch of Asundexian in EMEA.

At Bayer NV.

• Local management of all phases of a clinical trial in a team with CRA's/CTA's
• Connector between local and global study team

At Thrombogenics NV.

• Global project Management (senior level) outsourced for Monitoring activities to a global CRO
• Vendor and budget management
• Responsible for project deliverables and reporting to board of Management

Accomplishments:

- implementation of incentives to stimulate project deliverables

- developed flexible/adaptable/ attitude and roles

• 19 Direct reports in Be/Neth
• Establish and maintain relationship with customer (sponsor and investigators)
• Performance and development management of staff
• Accountable for project deliverables with high quality standards
• Assure qualitative resources and flexible assignment on projects

Accomplishments:

• Support 2 successful FDA Inspections
• Support implementation of a Start-up group responsible for trial submission

• Lead Clinical Research Associate
• Clinical Research Associate
• Drug Supplies, Labeling and Site Documentation Associate (global Level)
• Interactive Voice Response System assistant.

Revalidation and rehabilitation of general/ sport injuries