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Job Details

Senior Regulatory Site Activation Manager - Site Start Up - Europe

Company: INC Research
Location: Europe
Reference: 16004864
Closing Date: 05 Jan 17
Type: Permanent
Salary (£): Negotiable

Job Summary:

Do you want to be part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development.


We are currently are looking to strengthen our Ethics and Regulatory department within Europe and are seeking a Senior Regulatory Site Activation Manager to be based in Europe.

A brief summary of duties you will be involved in as a Senior Regulatory Site Activation Manager:

•Acting as a key point of contact with the sponsor and INC team regarding all Regulatory activities for the assigned study
•Overseeing all associates assigned to work on the regulatory, ethics and essential document portion of the study
•Assuming responsibility on deliverables at the project level
•The planning, coordination and oversight of all processes involved in gaining approvals required in each country for a clinical trial to commence. This will include competent authority approvals, ethics committee approvals, import license approvals, radiation approval, tissue/biological sample export and any other local approvals required in a given country.
•Dealing with multiple countries and studies at any given time


To succeed in this role you will need the following skills/experience:
•Degree educated or equivalent in a science or healthcare field
•Direct experience making CA submissions across multiple countries
•Excellent understanding and experience in Regulatory laws, processes, mindset, document requirements, drug labeling requirements, and drug release requirements in multiple European countries

Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
“INC Research we’re ranked “Top CRO” to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).”

What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.


Apply for this job: Senior Regulatory Site Activation Manager - Site Start Up - Europe

Contact Information:

Address:  INC Research Europe
Királyhágó tér 8-9, 2th floor, 1126 Budapest, Hungary
Tel:  +36 1 489 48 56
Website:  Visit Our Web Site

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