Job Description

Overview

As a Senior Local Trial Manager you will be joining the world\xe2\x80\x99s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What Will You Be Doing

Working outsourced and fully dedicated to one of our global pharmaceutical clients, the Senior Local Trial Manager is responsible for the successful management and execution of study activities at a country level. Collaborating with the wider global study team, the Local Trial Manager leads the local team of Site Managers and Clinical Trial Assistants in order to deliver quality data and trial documents that are compliant with protocol, ICH-GCP guidelines, Standard Operating Procedures and regulatory requirements.

Key Tasks Include (But Not Limited To):

• Managing the local team to meet recruitment targets
• The efficient management of local vendors
• Timely review of trip reports submitted by Site Managers
• Targeted and effective study team training
• Preparation for audits
• Development of local study tools and procedures
• Proactive risk management and budget forecasting
• Accompanying Site Managers on on-site visits to ensure protocol compliance at a site level, and to foster positive working relationships with site staff, including Investigators
• Some on-site monitoring of assigned sites
• Managing studies from feasibility through to database lock and close-out, the Local Trial Manager acts as the key local manager throughout the lifecycle of the project

Qualifications

What Do You Need to Have:

• A minimum of a 4-year Bachelor\xe2\x80\x99s degree or relevant clinical experience is required
• Advanced: 3 to 5+ years of trial management experience.
• At least 2 years of Oncology experience required
• Solid understanding of the drug development process including ICH/GCP and local regulatory requirements.
• Solid communication and computer skills required.
• Proficient in speaking and writing the country language and English language.
• Good written and oral communication skills.
• Willingness to travel with occasional overnight stay away from home depending on the region.
• Flexible mindset and ability to work at a fast pace within small exploratory study teams.
• Ability to work on multiple trials in parallel in different disease areas.
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That\xe2\x80\x99s why we are committed to developing our employees in a continuous learning culture \xe2\x80\x93 one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

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, 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.

ICON