Senior Clinical Trial Manager

Sr Local Trial Manager – Solid Tumor 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 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. They are site aligned E2E partner to streamline communication across cross functional stakeholders throughout trial lifecycles.

  

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 

• Solid Tumor and/or 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 competitiv