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Senior Clinical Trial Manager
ICON plcSenior Clinical Trial Manager at ICON, ensuring high-quality trial delivery and overseeing local trial management processes. Collaborating with cross-functional teams and managing trial excellence at the country level.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Accountable for ensuring top-quality end-to-end trial delivery at a country level.
- Managing the consistency of Local Trial Management duties and processes.
- Serving as the country-level single point of contact on the study for internal partners.
- Managing and overseeing Central IRB and other local vendors including set up of 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.
- Inspection Readiness and AQR at the country level.
- Close collaboration with assigned Local Trial Managers, Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers.
- Efficient communication with Clinical Trial Managers and Global Trial Leader to oversee trial excellence.
- Conducting country level ad hoc meetings during any phase of the study to address unexpected circumstances.
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
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 managementfeasibility studiesdatabase locksdata cleaningoncologysolid tumorsICH-GCPprotocol managementlocal laws and regulationsstudy close out
Soft Skills
communicationcollaborationproblem-solvingleadershiporganizational skillsinspection readinessadaptabilityteamworkinterpersonal skillsmeeting facilitation
Certifications
BA/BS degreedegree in health-related fieldGCP certification