ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post : Study Start Up Associate I
Key Responsibilities
As a Study Start up Associate you will be responsible for the independent preparation, review and approval of country-related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines. This includes independent preparation, review and approval of site level essential documents for investigational drug release in accordance with regulatory and sponsor requirements. You would also be involved in the site start up activity for clinical research, investigative sites. You will play an important role in ensuring clinical sites are ready for the first day that the drug trial begins. You will prepare the regulatory binder, ship investigational product, ensure that all documentation is ready an available at the site, and make sure that sites are ready to be activated to enroll their first study patient. We are looking for someone who has experience working in a clinical environment and who is responsible to handle a variety of tasks in a short time frame. You should have knowledge of how an investigative study is run as well as regulatory requirements.
Candidate Profile
We prefer someone with a bachelor’s degree and a clinical background with strong clinical site management/ study start up experience. Experience collecting and submitting regulatory documents and communicating with investigative sites is preferred
Additional Information:
Experience: 3+ years exp
Location: Chennai
Education: Bachelor’s degree
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Study Start Up
End Date: 28th December, 2017
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