Senior Clinical Trial Manager

ICON plc • Blue Bell, SD

1d • Hybrid

About The Position

The Senior 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 Senior LTM will serve as the country-level single point of contact on the study for internal partners. While the Sr LTM may delegate tasks to other LTMs or roles on the study, the Sr LTM remains accountable for successful completion of those tasks. 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
• 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
• Legally authorized to work in the United States and not require sponsorship for employment visa status

Nice To Haves

• Start-up & Database Locks/Cleaning experience
• Oncology Solid Tumor experience

Responsibilities

• Ensuring top-quality end-to-end trial delivery at a country level
• Managing the consistency of Local Trial Management duties and processes
• Serving as the country-level single point of contact on the study for internal partners
• Managing and overseeing Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.)
• Setting up vendor purchase orders, invoice review and approval, and change-orders
• Executing local milestones from feasibility through study close out
• Resourcing of country-level roles, including support with transitions
• Ensuring Inspection Readiness and AQR at the country level
• Collaborating with LTMs, LSM, SMs, CTAs, and SCMs to outline accountabilities/responsibilities and provide support and training
• Communicating with CTMs, Clinical Operations and the GTL to oversee trial excellence
• Conducting country level ad hoc meetings to address unexpected circumstances
• Partnering with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks
• Assisting with documentation, such as storyboards, lessons-learned, metrics, etc.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees