Senior Clinical Trial Manager

Sr Local Operations Manager - Hematology Oncology - Home Based (US)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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

What you need to have 

• 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 

• 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

• 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

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply