Manager of Study Start Up

Overview

Study Start Up 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 seeking a Manager, Study Start-Up to join our diverse and dynamic team. This position serves as an expert in Study Start Up (SSU) activities and strategy including the use of various clinical systems (e.g. CTMS) to enable consistent and compliant forecasting and data collection. They will have a deep understanding of global site activation requirements and data flows.

• Manage and may lead the day-to-day operations within Global Study Start Up to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g. study teams) to support timely completion of both drug and non-drug program goals and objectives
• Manage and may lead functional and cross-functional internal teams
• Provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools
• Proactively identify and escalate issues that arise related to support functional deliverables.
• Responsible for implementation of standards for designated functional areas.
• Provide oversight and direction to team members for functional and study-related deliverables
• Accountable for functional budgets and resources (where appropriate) and responsible for the management of related components of trial or support function budgets, timelines and resources. May also provide oversight for these activities.
• Responsible and may be accountable for all activities associated with Study Start Up. This may include:
• Oversight of SSU activities from receipt of a potential site list to site activation including CDA and questionnaire collection, site selection, IRB/EC submissions, IMP Release and other site activation requirements
• Facilitating the development of the SSU Strategy and ensuring management of the strategy during the study start up period

• BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree
• Must have knowledge of clinical trial conduct, including, multi-center, global trials.
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Requires proven project management skills and leadership ability
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Experience in working cross functionally and with external providers
• Experience with development & implementation of process improvement related initiatives
• Global Experience with site activation activities including submission requirements.

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.

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, Life Works, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re…