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Job Details

Country Submission Specialist, Denmark (permanent)

Company: inVentiv Health Clinical
Location: Denmark
Reference: CSS.DEN
Closing Date: 01 Jan 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Join Site Centricity Unit within inVentiv Health Clinical in Denmark as a Country Submission Specialist. See and get to know us better - https://youtu.be/YQgaDu0L-CQ.

Requirements:

Role: Country Submission Specialist

Department: Essential Document Collection and Submissions (EDCS), Site Centricity Unit

Contract: permanent, full-time

Location: home-based, Denmark

 

Main responsibilities:

  • 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.
  • Train and mentor other associates on local regulations and internal procedures.
  • Complete assigned training programs and apply learning.
  • Complete necessary administrative tasks.
  • May perform other duties as assigned. 

 

Requirements

  • Undergraduate degree or RN in a related field or equivalent combination of education, training and experience
  • Two and one-half (2.5) years clinical research/monitoring experience including two (2) years 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

Apply for this job: Country Submission Specialist, Denmark (permanent)

Contact Information:

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

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

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