Clinical Study Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently looking to hire experienced Clinical Study Managers to work within our FSP division at ICON. This is a client dedicated role where you will work exclusively on one sponsor's trials and SOPs.

Job Summary: 

The Clinical Study Manager (CSM) will have responsibilities for local studies and specific country level activities from study startup through conduct and study close. You will have responsibility for study management aspects of assigned studies of limited complexity (e.g. single country, a small number of countries/sites) or manage a unique part of a larger study (e.g. recruitment and retention). You will be assigned to one or more studies and will be tasked with taking on responsibilities in support of Global Study Managers, other Study Operational Managers and the larger Study Management delivery of the study. 

What you will be doing:

• Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close out.
• May manage the study start up process in countries assigned and/or oversee CRO responsible for these activities as applicable
• Communication with the local team and internal stakeholders and CRO as applicable and as listed above to ensure efficient and timely study delivery of the agreed plans
• Responsible for study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
  
• Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager to Global Study Manager during planning
• Leader of the Local Study Team
• Ensures compliance to relevant Global and Local, internal and external requirements and regulations
• Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams
• Follows up on country level issue status to ensure resolution.
• Identifies country level trends to improve deliverables processes as needed
• Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies
• Ensures audit/Inspection readiness during start-up and conduct
• Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets
• Responsible to drive and ensure delivery of data cleaning deliverables for CRO and sites as applicable
• Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable
• May act as a Subject Matter Expert
• May lead operational effectiveness initiatives at country level
• Responsible for PTA and SIV report review

Requirements:

• Previous clinical research experience
• Minimum of 1 year of local study management experience
• Demonstrated experience in managing country level operational activities and/or vendors
• Experience in Study and Quality management and working in a matrix management environment
• A scientific or technical university degree is preferred along with knowledge of clinical trial methodology (BS/BSc/MS/MSc)
• Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
• Knowledge of fluent English and Bulgarian language are required

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/benefits

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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 or submit a request here.

Interested 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.

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