Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Manager, Clinical Study Lead role.
Rezi rewrites your resume against Regeneron Pharmaceuticals's job description. Free.
Tailor your resume to this Manager, Clinical Study Lead role.
Rezi rewrites your resume against Regeneron Pharmaceuticals's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Manager, Clinical Study Lead posting at Regeneron Pharmaceuticals — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Manager, Clinical Study Lead posting at Regeneron Pharmaceuticals — free, in seconds.
About the Role
Lead assigned clinical trials from study design through close-out while collaborating with cross-functional study teams, vendors and leadership. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Responsibilities
- Lead cross-functional study teams and global, regional or country execution of assigned clinical trials.
- Shape protocols, study documentation, feasibility, site selection, investigator meetings and recruitment strategies.
- Manage timelines, budgets, risks, vendors, supplies, study systems, activation, monitoring and data quality.
- Maintain Clinical Trial Management System and Trial Master File readiness, including registry, audit and inspection compliance.
- Escalate study issues and implement corrective actions with Program Operations Lead, Country Operations Lead and stakeholders.
- Lead close-out, including database lock, vendor reconciliation, budgets, Trial Master File and study drug accountability.
- Support study reports, lessons learned, staff deliverables, process improvement, unmasked activities and potential line management.
- Use data-driven thinking to strengthen study execution and continuous improvement.
Requirements
- Bachelor’s degree and at least six years of relevant industry experience.
- Global clinical trial operations experience, including protocols, key study documents and budget and vendor management.
- Knowledge of International Council for Harmonisation Good Clinical Practice and applicable regulatory guidelines.
- Proficiency with trial management systems, Microsoft applications, Interactive Voice Response Systems and electronic data capture.
- Project management, cross-functional leadership, organization, communication, influencing and negotiation skills.
- Ability to implement operational strategy, meet deadlines, prioritize effectively and build productive study teams.
- Industry awareness, proactive self-discipline and a data-driven approach to planning, execution and problem-solving.
Skills
- Project management
- Cross-functional leadership
- Organization
- Communication
- Influencing
- Negotiation
- Data-driven thinking
Location
- Tokyo, Japan
Work Type
- Hybrid
Experience Level
- At least six years of relevant industry experience
Education Level
- Bachelor’s degree
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
- We believe we do our best work when we are together.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.