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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Local Trial Management, ensuring compliance with ICH-GCP and local regulations while effectively collaborating with cross-functional teams. Proficient in managing trial milestones and vendor relationships to deliver high-quality clinical trials.
Highest-signal resume keywords
Local Trial Management ExperienceOncology Trial Management ExperienceStrong Knowledge of ICH-GCPCross Therapeutic Area Trial ManagementProficient in English and Country Language
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Local Trial ManagementOncology Trial ManagementStart-Up ExperienceDatabase Lock ExperienceFeasibility ExecutionInspection ReadinessVendor ManagementProtocol ComplianceMetrics DocumentationClinical Trial Processes
Soft Skills
Good Written CommunicationGood Oral CommunicationCollaboration SkillsProblem-Solving Skills
Tools & Technologies
Clinical Trial Management SoftwareCompany Systems
Industry Keywords
ICH-GCPREB SubmissionsHealth or Science DegreeCanadian RegulationsClinical Operations
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- The 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
- 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, 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), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to outline accountabilities/responsibilities and provide support and training, where necessary
- Efficient communication with the 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 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
Requirements
What you’ll need- BA/BS degree
- 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 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
- Must be legally authorized to work in Canada and should not require, now or in the future, sponsorship for employment visa status
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways