Sr Study Start Up Associate

Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. *Travel (approximately 15%) domestic and/or international. Anticipated activities may include attendance at Bid Defences, Kick-Off, Investigator or study team meetings. Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned. *Provide country specific Study Start Up expertise to Study Start 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 Sheets/Informed Consent Forms (SIS/ICFs). *Prepare, finalize and review Master and Country Specific EU Clinical Trial Application Forms and corresponding data files in collaboration with other relevant departments (xml file) (EU Only). *Review and translate Drug labels. *Perform independent quality review of submission packages. *Responsible for the translation and co-ordination of translations for documents required for submission. *Perform timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system. *Copy and route incoming correspondence, internal documentation, etc., as appropriate. *Responsible for the timely follow-up for queries made by EC/CA. *Responsible for the collection of critical documents required for IP Release. Responsible for the dispatch, negotiation, execution and tracking of contract with sites and other sites, as appropriate. *Responsible for the timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system in assigned countries. *Attend study team meetings as required, including Kick-Off Meeting. Assemble and distribute study materials to Clinical and Project teams, including materials to study sites and Investigator Meetings (e.g.; investigator binders) and vendors, as appropriate. (US only) *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 and update relevant ICON information system. *To be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs. Competent in communication and influencing skills to ensure timely follow-up, issue resolution and report updates; as outlined in the communication and escalation plan with timely documentation. Perform regulatory document maintenance; amendments, periodic updates and safety letters, where applicable *Develop and maintain effective relationships with local, regional and country authorities *Comply with all department requirements regarding information provision and status updating and reporting To undertake and fulfill Study Start Up Team Lead role activities as per the Study Start Up Team Lead scope definition in preparation for future career progression to Study Start Up Team Lead. To undertake other reasonably related duties as may be assigned from time to time Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. *Travel (approximately 15%) domestic and/or international. Anticipated activities may include attendance at Bid Defences, Kick-Off, Investigator or study team meetings. Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned. *Provide country specific Study Start Up expertise to Study Start 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 Sheets/Informed Consent Forms (SIS/ICFs). *Prepare, finalize and review Master and Country Specific EU Clinical Trial Application Forms and corresponding data files in collaboration with other relevant departments (xml file) (EU Only). *Review and translate Drug labels. *Perform independent quality review of submission packages. *Responsible for the translation and co-ordination of translations for documents required for submission. *Perform timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system. *Copy and route incoming correspondence, internal documentation, etc., as appropriate. *Responsible for the timely follow-up for queries made by EC/CA. *Responsible for the collection of critical documents required for IP Release. Responsible for the dispatch, negotiation, execution and tracking of contract with sites and other sites, as appropriate. *Responsible for the timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system in assigned countries. *Attend study team meetings as required, including Kick-Off Meeting. Assemble and distribute study materials to Clinical and Project teams, including materials to study sites and Investigator Meetings (e.g.; investigator binders) and vendors, as appropriate. (US only) *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 and update relevant ICON information system. *To be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs. Competent in communication and influencing skills to ensure timely follow-up, issue resolution and report updates; as outlined in the communication and escalation plan with timely documentation. Perform regulatory document maintenance; amendments, periodic updates and safety letters, where applicable *Develop and maintain effective relationships with local, regional and country authorities *Comply with all department requirements regarding information provision and status updating and reporting To undertake and fulfill Study Start Up Team Lead role activities as per the Study Start Up Team Lead scope definition in preparation for future career progression to Study Start Up Team Lead. SUPERVISION (List statements in bullet format. Put an asterisk* next to each essential function.) To undertake other reasonably related duties as may be assigned from time to time