Clinical Trial Manager

Local Trial Management services provides local management of a clinical trial (or Medical Affairs datageneration activity) in a country or countries. Services/deliverables include operational oversight ofassigned protocol(s) at the country level from start-up through to database lock and closeout activities.Further, services will ensure the local trial team is delivering quality data and trial documents/records thatare compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs),International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatoryrequirements. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), SiteManager (SM) and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery atthe country level.

What you will be doing:

• Services rendered will adhere to applicable clients SOPs, WIs, policies, codes of GoodClinical Practice (GCP), local regulatory requirements, etc.• Complies with relevant training requirements. • Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report andcountry feasibility report. Collaborates with central study team and local stakeholders as applicabfor final selection of sites to participate in trial.• Ensures local/country team is meeting recruitment targets with high quality data on time andwithin study budget by providing input to study level documents and leading/coordinating localteam activities in compliance with SOPs, other procedural documents and applicable regulations.This may require development of local trial specific procedures and tools, recruitment planning,contingency and risk management, and budget forecasting. • Act as primary company contact for assigned trial at the country level, may attend/participate inInvestigator Meetings as needed. May schedule and conduct a local/country investigator meeting• Drive study compliance by maintaining and updating trial management systems, using study toolsand management reports available to analyze trial progress. When necessary initiates correctiveand preventive actions (CAPA) when the trial deviates from plans and communicates study progressand issues to study management teams and Quality & Compliance team.• Contribute to site level recruitment strategy and contingency planning and implementation inpartnership with other functional areas to achieve clinical research target.• Delivers competent vendor management at the country level to support the study and may submitrequests for vendor services and support vendor selection. This includes reviewing and approvingsite and local vendor invoices as required. As required, manages the local study supply.• Ensures high standards for study monitoring by conducting quality local trial team meetings andfacilitating SM training, when needed (i.e. implementation of study amendment-and changes instudy related processes).

You are:

• BA/BS degree.• Degree in a health or science related field.• 2 years of local trial management or mutually agreed clinical trial experience.o Advanced: 3 to 5+ years of trial management experience.• Specific therapeutic area experience may be required depending on the position.• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws andregulations, assigned protocols and associated protocol specific procedures.• Strong IT skills in appropriate software and company systems. Willingness to travel with occasionalovernight stay away from home according to business needs. • Proficient in speaking and writing the country language and English. Good written and oralcommunication skills as appropriate.

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.