Study Start-up Associate (Contracts)

March 6, 2013 by · Comments Off on Study Start-up Associate (Contracts)
Filed under: Clinical Research, Regulatory Affairs 

A leading biopharmaceutical company  is looking for an enthusiastic and experienced  Study Start-up Associate (Contracts)

Role and Responsibilities

– Prepare study-specific Clinical Trial Agreements templates with investigators and institutions for study management teams
– Negotiate budget costs and contract language with the appropriate party at the sites
– Assist with developing a budget template and determining reasonable procedure costs after thorough reading of the protocol
– Liaise with CTA Department to resolve individual contract language regarding issues that fall outside the allowable contract terms
– Maintain status tracking tool for individual sites for each study
– Maintain open communication and participate in regular meetings/teleconferences with study teams

What is Required

– BA/BS with at least 3 years of experience in pharmaceutical clinical research including contract preparation and negotiation
– Expert knowledge of ICH and GCP guidelines
– Good communication skills are mandatory
– Demonstrated ability to be customer oriented to the investigator and site personnel in order to achieve high customer satisfaction levels
– Demonstrated ability to prioritize and manage multiple complex tasks
– Demonstrated ability to attend to detail and solve problems
– Demonstrated ability to work with multiple study sites in several therapeutic areas                                                                                                                                                                                              – English written & spoken at fluent level

What is offered

This is a great opportunity to join an international company working on a cutting-edge projects!                                                                                                                        The position is Office based (Milan) or Home base (previous experience required)
Full time for 6 months with possibility of Permanent Contract
Interesting Salary

If you’re interested , please send an English Cv at alessandra.arensi@docsglobal.com quoting the reference AS- 2400.

Site Start-Up Specialist Office-Based Milano

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