Senior Clinical Trial Manager

ICON plc • Blue Bell, SD

1d • Remote

About The Position

The Senior LTM role is a site aligned E2E partner to streamline communication across cross functional stakeholders throughout trial lifecycles. Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution. Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams. Principal Local Operations Manager: trial aligned member of CFTT for USA-level accountability, serves as “quarterback” for Local Operations Managers and representing a single voice to global team. The Sr 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. Autonomy with execution of local trial management services Depth of knowledge with local trial management services Process leadership

Requirements

• BA/BS degree.
• Degree in a health or science related field.
• 3 - 5+ years of trial end to end management experience
• Hematology Oncology experience required
• 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
• 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.

Nice To Haves

• Start-up & Database Locks/Cleaning experience preferred

Responsibilities

• Manage and oversee 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).
• Ensure Inspection Readiness and AQR at the country level.
• Collaborate closely with 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.
• Communicate efficiently with Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to oversee trial excellence.
• Conduct 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.
• Partner closely 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.
• Execute local trial management services with autonomy.
• Demonstrate depth of knowledge with local trial management services.
• Provide process leadership.

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: Senior