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Study Start-Up and Regulatory Specialist

Employer
RBW Consulting
Location
Netherlands
Salary
Salary: On application
Start date
5 Feb 2021
Closing date
7 Mar 2021

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

I’m currently looking for a Study Start-Up and Regulatory specialist based in The Netherlands.


Responsibilities:

  • Performs assigned activities across Netherlands 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 Netherlands
  • Excellent verbal, interpersonal, and written communication skills in Dutch and English
  • Strong knowledge of clinical trials
  • 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.

 

Salary: On application

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