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Freelance Study Start-Up and Regulatory Specialist

Employer
RBW Consulting
Location
Netherlands
Salary
Day/Hourly rate: On application
Start date
5 Jan 2021
Closing date
4 Feb 2021

View more

Discipline
Clinical Research, Study Start Up
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

I’m currently partnered with a Global CRO that’s looking for a Freelance Study Start-Up and Regulatory Specialist based in Netherlands on a 9 month contract for a full FTE.

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

 

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

 

Day / Hourly Rate: On application

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