Company: Novella Clinical Resourcing
Closing Date: 11 Nov 16
Type: Full Time
Salary (£): Competitive
Benefits: Dependent on Location
A new and pivotal position within the European operation as we look to streamline the start up process and introduce the Study Start-Up department. This will be a first time hire for this department and we are looking for people based across the EU, primarily interested in professionals in Italy, UK, Spain, Germany, France or Belgium. Experience in Study-Up for local/EU Clinical trials including Qualtiy Assurance, Regulatory Submissions related to Study Start Up.
Novella Clinical is looking for an experienced Clinical Study Start-up Specialist to join our new Study Start-Up Unit in the EU. Study Start-up Specialists are responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) throughout the clinical study. Work with both internal and external teams to assure good communication, regarding documentation processing. Assure documents maintained in ISSC are in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by Novella and its clients.
This is a new and pivotal position within the European operation as we look to streamline the start-up process and introduce the Study Start up department. This will be a first time hire for this department and we are looking for people based across the EU, primarily interested in professionals in Italy, UK, Spain, Germany, France or Belgium.
Key Skills & Responsibilities:
If you would like to discuss this role and department in more detail I would be pleased to receive your CV and set up a call to go over the details. This is a great opportunity to join a new department and make a huge impact in the direction and service provision of Novella Clinical.
Please feel free to get in touch via email or phone to discuss this further (firstname.lastname@example.org/+441438794519)
Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
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