Start-Up Specialist

ICON plc

78d

About The Position

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.

Requirements

• BS/BA degree or Associates degree with ≥2 years of experience in clinical trial related start-up experience.
• ICF negotiation experience.
• Must have knowledge of clinical trial conduct.
• General knowledge of drug development and ICH/GCP guidelines.
• Requires proven project management skills.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Fluent in English.

Responsibilities

• Support the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• 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.
• Generate and 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 SSU deliverables.
• Effectively execute against assigned activities within SSU.
• Support implementation of standards for global SSU team.
• Oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other site activation requirements.
• Implementation of the SSU Strategy for assigned region during the study start up period.
• Building relationships with internal counterparts and site staff to support successful site activation strategies.
• Projecting site activation timelines and appropriately escalating when things get off track.
• Adhering to process and tools designed to the support of the SSU team with day-to-day activities.
• Leading the preparation of study level essential document templates.
• Aiding in the preparation of content for Regulatory submissions.
• Handling ICF negotiations and facilitating any required escalations.
• Preparation and submission of IMP Release Packages.
• Maintaining accurate and timely information in relevant clinical systems.
• Responsible for complying with regulations and guidelines and ensuring adherence in support of assigned clinical trials.

Benefits

• 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, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees