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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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.
- The Sr LTM will manage and oversee the following throughout the study: 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.
- Autonomy with execution of local trial management services.
- Depth of knowledge with local trial management services.
- Process leadership.
Requirements
What you’ll need- 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.
- Oncology Solid Tumor experience required.
- Specific therapeutic area experience may be required depending on the position.
- 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.
- 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.
Benefits
Comp & perks- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize 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.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
trial managementend-to-end trial deliveryvendor managementfeasibility assessmentinspection readinessdata cleaningoncology solid tumor experienceICH-GCP knowledgeprotocol managementlocal trial management services
Soft Skills
communication skillscollaborationleadershipautonomyproblem-solvingtrainingaccountabilityorganizational skillsadaptabilityinterpersonal skills
Certifications
BA/BS degreedegree in health or science related field