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Job Details

Freelance Country Submission Specialist, Netherlands

Company: inVentiv Health Clinical
Location: Netherlands
Reference: 14085
Closing Date: 11 Nov 16
Type: Contract
Salary (£): Negotiable

Job Summary:

Freelance Country Submission Specialist - 6 month contract/ 1FTE


Freelance Country Submission Specialist, Netherlands

Home based (6 months / 1 FTE)

Job Description:

* Conduct research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation, and provide updates of local processes and requirements to the Regulatory Intelligence portal.
* Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.
* Compile and submit CTAs to Regulatory Authorities and IRB/EC (if applicable)
* Complete review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process.
* Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents.
* Complete review of essential documents following Essential Document Checklist QC.
* Arrange and review translations of relevant study documents.
* Provide regular local status updates to project lead; update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems as required for assigned projects.
* Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
* Support other departments as necessary

* Identify site issues during start-up process, resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.
* Complete necessary administrative tasks.
* May perform other duties as assigned.

* Train and mentor other associates on local regulations and internal procedures.
* Complete assigned training programs and apply learning.

Experience Required:

* Previous experience in clinical research or monitoring; including study start-up experience
* Ability to learn and follow task-specific procedures, be attentive to detail and place importance on accuracy of information

* Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
* Strong organizational skills

* Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
* Ability to work with minimal supervision in a fast-paced environment with a sense of urgency to match the pace
* Must demonstrate good computer skills

* Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

* Occasional travel may be required

Education Required:

* Bachelor's Degree in life science, pharmacy, nursing or RN, Or equivalent clinical research experience

Apply for this job: Freelance Country Submission Specialist, Netherlands

Contact Information:

Address:  Poland (Polska)
Ul. Nowogrodzka 68
02-014 Warsaw (Warszawa)

Reasons to work for inVentiv Health Clinical
Website:  Visit Our Web Site

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