[Hiring] Local Trial Manager @ICON plc

Role Description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

The LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes. The LTM will serve as the country-level single point of contact on the study for internal partners. While the LTM may delegate tasks to other LTMs or roles on the study, the LTM remains accountable for successful completion of those tasks.

The LTM will manage and oversee the following throughout the study:

• Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.) including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable.
• Execution of local milestones from feasibility through study close out.
• Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM).
• Inspection Readiness and AQR at the country level.
• Close collaboration with the assigned Local Trial Manager(s) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and provide support and training, where necessary.
• Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to oversee trial excellence.
• Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables.
• Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership.

Qualifications

• BA/BS degree.
• Degree in a health or science related field.
• 2 years of local trial management or mutually agreed clinical trial experience.
• Start-up & Database Locks/Cleaning experience preferred.
• Immunology experience strongly preferred.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel with occasional overnight stay away from home according to business needs.
• Proficient in speaking and writing the country language and English.
• Good written and oral communication skills as appropriate.

Requirements

• 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.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Benefits

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.