Company: INC Research
Closing Date: 24 Nov 16
Salary (£): Negotiable
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.
At INC Research we appreciate the importance of having experts dedicated to the set up stages of the studies, and for this reason we have a devoted Study Start Up team with departments focused upon Site Identification and Feasibility, Site Contracts, Ethics and Regulatory and Patient Recruitment.
As a member of our Study Start Up team you will traverse all therapeutic areas and phases, providing your expertise at this vital period of time in the study. This expertise at this critical time has resulted in the average study start up time four weeks faster than industry standard.
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.
European Head Office
River View, The Meadows Business Park,
|Tel:||+44 (0) 1189 335 300|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.