Ref #: 22226

Employment type: Permanent - Full-Time

Location: Belgium

Posted: 02-Nov-2020

Description

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%


Requirements
• 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 www.docsglobal.com or ken.falorni@docsglobal.com or iris.brouwer@docsglobal.com

We are looking forward to your application!


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