Study Start-Up and Regulatory Specialist

Location Netherlands
Discipline: Clinical Research
Job type: Permanent
Salary: £Salary: On application
Contact name: Roxanna Keshavarz

Contact email: Roxanna.Keshavarz@rbwconsulting.com
Contact phone: 01293584300
Job ref: 21072
Published: about 1 month ago
Expiry date: 11 April 2021

​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