The L-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 L-LTM will serve as the country-level single point of contact on the study for internal partners.
While the L-LTM may delegate tasks to other LTMs or roles on the study, the L-LTM remains accountable for successful completion of those tasks.
Manage and oversee Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.…), including vendor purchase orders, invoice review and approval, and change-orders.
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.
Inspection Readiness and AQR at the country level.
Close collaboration with LTMs, Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to outline accountabilities/responsibilities and provide support and training.
Efficient communication with Clinical Trial Managers, Clinical Operations and the Global Trial Leader to oversee trial excellence.
Country level ad hoc meetings during any phase of the study to address unexpected circumstances.
Close partnership with the study Functional Manager to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation such as storyboards, lessons-learned, metrics, etc.
Requirements
BA/BS degree. Degree in a health or science related field.
2 years of local trial management experience requied.
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