Freelance Study Start-Up and Regulatory Specialist
- Company
- RBW Consulting
- Location
- Netherlands
- Salary
- Day/Hourly rate: On application
- Posted
- 05 Jan 2021
- Closes
- 04 Feb 2021
- Ref
- HJ-RK-FSSU-RS-9MC-EU-050121
- Discipline
- Clinical Research, Study Start Up
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
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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