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 quoting the reference AS- 2400.

SSU Associate International CRO

September 4, 2012 by · Comments Off on SSU Associate International CRO
Filed under: Clinical Research 

We offer a broad range of specialised services to assist pharmaceutical, biotechnology and medical device companies to bring new drugs and devices to market faster. Our services span the entire lifecycle of product development and can be adapted to suit small local trials or large global programs.

SSU Associate
The main role of a Study Start-Up Associate is perform activities associated with study site initiation process according to applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.

Job Profile
The ideal candidate will be responsible for the review  Read more