
Local Trial Manager - Oncology - Canada - Home Based
- Canada
- Permanent
- Full-time
- 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.
- BA/BS degree.
- Degree in a health or science related field.
- 2 years of local trial management experience requied.
- 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 standard operating procedures, local laws and regulations (i.e. Canadian), REB submissions, 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 Canada and should not require, now or in the future, sponsorship for employment visa status
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise 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