At ICON, it's our people that set us apart.
As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?
We are looking for someone with strong study start up experience to join our Study Start Up group. Our Study Start Up associates are integral in ensuring that physicians at research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.
Summary
Senior Study Start Up Associate understands client objectives and assist the Study Start Up Team Lead in the development of the plan for country and site distribution an their assigned countries, while performing assigned study start up activities. This person acts as a deputy for the country Study Start Up Manager as appropriate.
Job Description
* Attendance at Bid Defense, ,Kick-Off,Investigator or study team meetings
* Perform feasibility , site-identification ,site contract negotiation, and other study start up activities assigned
* ·Provide country specific Study Start Up expertise to Study Stan Up Team Leads and project teams.
* Responsible for the preparation and coordination of submissions to regulatory, ethics and other bodies
* 'Develop, finalize and review Master and Country Specific Subject Information Sheet and Informed Consent Forms.
* Review and translate Drug labels
* 'Perform independent quality review of submission packages
* Perform timely and accurate data entry of all relevant Study Stan Up activities into the appropriate clinical trial management system
* Responsible for the timely follow-up of queries made by EC/CA
* Responsible for the collection of critical documents required for IP Release
* Responsible for the budget,negotiation execution and tracking of contract with sites.
*·Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee EC submission information and similar information for other related organizations,for the assigned countries.
*·To be familiar with ICH-GCP, and relevant country regulations/guidelines and ICON SOPs
* Perform regulatory document maintenance,amendments periodic updates and safety letters,where applicable
* Develop end maintain effective relationships with local,regional and country authorities
Role Requirements
- Bachelor's Degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline
- Global clinical trials experience with awareness of global regulatory requirements for clinical site initiation documents
- Proven experience handling study start ups for more than 2+ years
ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.
EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin