Freelance Study Start-Up and Regulatory Specialist

I’m currently looking for a Freelance Study Start-Up and Regulatory specialist in Belgium to work with a global CRO.

Responsibilities:

• Performs assigned activities across Belgium in all phases of clinical trials
• Provide delivery and expertise in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, as well as review and finalise essential documents required for site initiation
• Develops plans in accordance with Standard Operating Procedures as well as complying with all controlled documentation requirements to ensure quality results
• Accountable for negotiations and executions of clinical trial agreements and budgets
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOPs

Requirements:

• Background in regulatory submissions across Belgium
• Excellent verbal, interpersonal, and written communication skills in French, Dutch and English
• Strong knowledge of clinical trials
• Currently working as a freelancer
• BA/BS degree in the science/health care field
• Ability to successfully support internal and external customers

This exciting SSU & Regulatory specialist role in a Global CRO is well suited to someone who has strong management skills and is able to hit the ground running.

To discuss this role in further detail, please get in touch on +44 1273 952187 for more information.