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Job Details

Clinical and Regulatory Start Up Manager (Europe)

Company: Premier Research
Reference: STARTUP-EU
Closing Date: 18 Nov 16
Type: Permanent
Salary (£): Competitive

Job Summary:

Premier Research are a growing global CRO focused on delivering high quality clinical research projects to their diverse client base. With industry leading expertise in Paediatrics, Analgesia, Oncology and CNS we are looking for career focused individuals who want to be a part of our growth


Role: Clinical and Regulatory Start Up Manager    

Location: Europe - Poland, Spain, Italy, Czech Republic, Romania, Bulgaria 

Job Type: Permanent  

Premier Research helps highly innovative biopharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and paediatric research. 

We’re looking for a talented and energetic Clinical and Regulatory Start Up Manager to join our team! You will be required to ensure the continuous improvement of quality of all Regulatory and Start-up components at the project level. This is a global position. 

You'll be accountable for:

  • Preparing Core Clinical Trial Applications for competent authorities
  • Driving the overview of applications done by Start-up Managers to competent authority (CA) and Ethics Committees /IRBs
  • Producing or reviewing some submission components like the Patient Information Form/ICF and or Investigational Medicinal Product Dossier (IMPD) or equivalent document as required
  • Maintain good, friendly and professional relationships with past, current and potential sponsors
  • Contribute to the business development process by reviewing proposals, budgets and attending client meetings
  • Keeping abreast of scientific developments and maintain technical expertise 
  • Working with the PM to understand financial aspects of the project; cascades to all start-up team members the number of hours/tasks available per contract; monitors project performance

You'll need this to be considered: 

  • Education to university degree level in pharmacy, medicine or related natural sciences
  • Strong experience, including previous experience in Regulatory or Start-up functions ideally on a global level
  • Hands-on experience in the submission of clinical trial applications
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities
  • Maintains a positive, results orientated work environment
  • Ability to read, write, and speak fluent English

If you are looking for a career within a transparent and non-hierarchical organisation then please contact us at the email address listed below. We are open minded and flexible regarding the talent we recruit, ultimately we are looking for people who will share in our vision and realise the importance of communication, building relationships and adhering to the highest quality standards.

For more information about careers at Premier please visit our careers site at   

Please note:-
You must be eligible to live and work in the specified country in order to apply for this role.

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Apply for this job: Clinical and Regulatory Start Up Manager (Europe)

Contact Information:

Address:  European Headquarters
1st Floor,
Rubra 2
Mulberry Business Park,
RG41 2GY
View our Profile Page
Tel:  +44 (0) 118 936 4000
Fax:  +44 (0) 118 936 4001
Website:  Visit Our Web Site

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