Trial Manager – Oncology
ICON plc
Google Cloud Platform
Job Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- Accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level
- Serve as the country-level single point of contact on the study for internal partners
- Manage and oversee Central IRB and other local vendors including set up of vendor purchase orders, invoice review and approval, and change-orders
- Execute local milestones from feasibility through study close out
- Resource country-level roles, support transitions in collaboration with Functional Manager
- Inspection Readiness and AQR at the country level
- Collaborate with LTMs, LSM, SMs, CTAs, SCMs to outline accountabilities and provide support/training
- Communicate efficiently with CTMs, Clinical Operations and GTL to oversee trial excellence
- Organize country level ad hoc meetings to address unexpected circumstances
- Partner with study FM to provide updates, discuss hurdles, timelines/resources, risks, and assist with documentation such as storyboards, lessons-learned, metrics
Requirements
- BA/BS degree in a health or science related field
- 2 years of local trial management experience required
- Start-up & Database Locks/Cleaning experience preferred
- Cross therapeutic area trial management experience required
- Oncology trial management experience required
- Early Development experience an asset
- Strong working knowledge of ICH-GCP, company SOPs, local laws and regulations (i.e. Canadian), REB submissions, assigned protocols and 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
- Must be legally authorized to work in Canada and not require sponsorship now or in the future
