Ref #: 24818

Employment type: Fixed term - Full-Time

Location: Netherlands

Posted: 06-Nov-2020


Key responsibilities:
• Perform site qualification, site initiation, and closeout visits, ensuring regulatory and protocol compliance. Visits may be on-site or remote.
• Generate queries and manage resolutions with site personnel.
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs and other required study documents as per SOPs and Study Monitoring Plan.
• Perform investigational product accountability as per the protocol and Study Monitoring Plan.
• Ensure to set up proper recruitment/maintenance plan based on appropriate analysis of capability of sites selected.
• Act as primary liaison with site personnel.
• Management and collection of site's study regulatory documents.
• Enter data into tracking systems as required.
• Assist and support audit preparation and CAPA implementation.
• AE/SAE and expedited reporting and management.
• Travel frequency of up to 60%

• Degree in life sciences, pharmacy preferred.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Proven experience in on-site monitoring of clinical studies is a must
• Demonstrated proficiency in problem solving, juggling multiple priorities and a commitment to quality and customer focus.
• Proven ability to work independently in a fast-paced environment.
• Strong communication, interpersonal, and organizational skills.
• Must demonstrate good computer skills.
• Ability to travel as necessary up to 70% depending on assignment. Overnight and occasional weekend travel may be required.
• Fluent communication skills in local languages (NL and/or FR) + English

What is offered:
• Largely Home Office Based
• Friendly work atmosphere in a great team
• Compensatory time-off
• Contribution to pension scheme
• Travel time = work time

Why this role is right for you:
We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a companies dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Interested? Please submit your CV via or or

We are looking forward to your application!