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Job Details

Clinical Submissions Specialist, Start-Up - Netherlands - €5000 Joining Bonus-145287

Company: PPD
Location: Europe, Middle East & Africa-Netherlands-Gelderlan
Reference: 145287
Closing Date: 20 Aug 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

PPD is currently offering a €5000.00 Joining Bonus to new starters, hired into this position*   PPD is recruiting a Clinical Submissions Specialist to join our Start-Up/Site Intelligence & Activation (SIA) department in The Netherlands. ...

Requirements:

PPD is currently offering a €5000.00 Joining Bonus to new starters, hired into this position*

 

PPD is recruiting a Clinical Submissions Specialist to join our Start-Up/Site Intelligence & Activation (SIA) department in The Netherlands. The Submissions Specialist will manage the preparation, review and coordination of local Ethics Committee and Competent Authority/Regulatory submissions in The Netherlands and will coordinate all activities to get investigation sites ready to enroll patients in our clinical trials.

 

Duties include:

•    Preparation, reviewing and coordinating local ethics committee and regulatory submissions in alignment with global submission strategy

•    Providing local regulatory strategy and advice

•    Acting as a key contact on a country level for all submission related activities and provide oversight for projects

•    Taking ownership of bringing qualified sites to the status of ‘ready to enrol’

•    Contacts sites to resolve issues and determines completeness and readiness of site for IP Approval.

•    Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

•    Ensures the study files and filing processes are followed for the documents sent to file as per PPD WPDs or applicable client SOPs.

•    Additional tasks in line with business and department need

 

*For a limited period, and for applications made by 20th July 2018.

Qualifications


*LI-LS1

Qualifications:

  • Bachelor’s degree in a life science subject
  • Regulatory and submission experience and a good knowledge of applicable local requirements. We would also accept applications from CRAs with submissions experience. 
  • Basic medical/therapeutic area and medical terminology knowledge
  • Excellent communication and organisational skills and a self-motivated, flexible and professional attitude. The ability to handle multiple tasks effectively, often within strict deadlines is essential.
  • Dutch and English language skills

IndeedPPDEMEA1


Apply for this job: Clinical Submissions Specialist, Start-Up - Netherlands - €5000 Joining Bonus-145287

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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