The Sr LTM Immunology 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.
Autonomy with execution of local trial management services
Depth of knowledge with local trial management services
Process leadership
BA/BS degree.
Degree in a health or science related field.
3 - 5+ years of trial end to end management experience
Start-up & Database Locks/Cleaning experience preferred
Immunology trial management experience highly 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
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.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
