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University leads major new research into wound care

17 September 2009

The University of York's Department of Health Sciences and NHS Leeds Community Healthcare have been awarded a £1.75m grant from the National Institute for Health Research to carry out a study into complex wounds.

GSK signs biologics manufacturing deal with Lonza
GSK signs biologics manufacturing deal with Lonza

German pharma market set for “subdued” growth
German pharma market set for “subdued” growth

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Company: Clinical Professionals
Category: Other Clinical Role
Position: ISIS ( International Study Inititiation Specialist) Manager - France
Area: Rest of Europe
Location: France
Notes: ISIS ( International Study Inititiation Specialist) Manager - France

The Company:

Our client is a leading international full service CRO with locations across the UK and Europe. They are a fantastic company to work for and offer unrivalled opportunity for personal development and career progression. They are looking for an ISIS Manager to run the ISIS( International Study Inititiation Specialist) department at their offices in Paris, France.


The key responsibilities of the ISIS Manager are:

- to coordinate and manage the start up activities of individual studies and staff in a manner that ensures timeline and quality targets are met
- to maintain a clear overview of regulatory developments. Monitor, identify and implement new regulatory strategies and requirements.
- Professionally represent the ISIS group to internal and external customers. Manage site audit inspections by regulators and customers. Negotiate with customers and regulators as required.


This role requires the following skills and experience:

• Thorough knowledge of regulatory and EC submission requirements in relevant countries.
• Thorough knowledge of ICH, ISO, GCP and other relevant regulations for the conduct of clinical trials related to pharmaceuticals, biologics, medical devices, and combination products.
• Good understanding of project management processes.
• Business acumen
• Strong people management and effective communication skills.
• Good commercial awareness and customer focus.
• Current full driving license.
• Ability and willingness to travel at least 35% of the time (international and domestic; fly and drive).



Key Words: International Study Inititiation Specialist Submissions Ethics Regulatory R&D Clinical Research France
Reference: fra441520
Contact: Clinical Professionals
Phone: 0118 959 4990
Apply: Click Here


   


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