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Senior Clinical Trial Manager
Elevar Therapeutics. Manage day-to-day planning and execution activities for assigned clinical trials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials from inception to completion, ensuring compliance with ICH/GCP guidelines and FDA regulations. Proven ability to lead cross-functional teams, manage budgets, timelines, and vendor relationships while maintaining audit-ready documentation.
Highest-signal resume keywords
Clinical Trial ManagementICH/GCP Guidelines KnowledgeProject Management SkillsCross-Functional Team LeadershipVendor Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial Work ExperienceGlobal Clinical Trials ManagementOncology ExperienceRemote Monitoring ExperienceBudget ManagementTimeline ManagementStudy Document ReviewAudit-Ready DocumentationTraining and Evaluation of Study PersonnelEnrollment Coordination
Soft Skills
Organizational SkillsInterpersonal SkillsTime ManagementMotivational LeadershipEffective Collaboration
Tools & Technologies
Microsoft Office ApplicationsAdobe AcrobatPowerPointElectronic Document Templates
Industry Keywords
Life SciencesCRO ExperienceFDA RegulationsClinical OperationsPharmacovigilanceQuality AssuranceClinical DevelopmentStudy Oversight PlansTrial Master FileAudit and Inspection Readiness
About the role
Key responsibilities & impact- Manage day-to-day planning and execution activities for assigned clinical trials
- Manage clinical study vendors and sponsor oversight activities
- Lead Clinical Operations and cross-functional clinical trial teams through trial planning, execution, and reporting
- Ensure study milestones, timelines, budgets, SOPs, ICH/GCP requirements, and applicable regulations are met
- Identify, communicate, escalate, and resolve operational issues
- Collaborate with Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Drug Safety and Pharmacovigilance, Clinical Supply, and clinical vendors
- Manage study timelines, budgets, vendor selection, vendor contracts, and expenditures
- Ensure recruitment targets are met and coordinate enrollment reviews and contingency plans
- Organize internal and external team meetings, investigator meetings, and trial-specific meetings
- Develop or facilitate Sponsor study oversight plans and study documents
- Review site study documents, investigator contracts, and site payments
- Manage Sponsor oversight activities, including trip report review and CRO oversight monitoring visits
- Participate in selection, training, and evaluation of study personnel
- Support or facilitate training of junior Clinical Operations members
- Maintain audit-ready Trial Master File documentation and coordinate quality control at study closure
- Support audit and inspection readiness activities
- Perform other related duties as assigned
Requirements
What you’ll need- BA/BS degree or equivalent years of experience, preferably in Life Sciences
- At least 5+ years of clinical trial work experience
- Minimum of 4 years effectively managing a clinical study from inception to completion
- Remote or on-site monitoring experience desirable
- CRO/industry experience acceptable
- Knowledge of ICH/GCP guidelines, including interpretation and implementation of FDA regulations
- Ability to work in a fast-paced environment and navigate unexpected events
- Demonstrated ability to lead and motivate cross-functional teams
- Essential time management and project management skills
- Proven experience managing global clinical trials, preferably in Oncology
- Proficiency with Microsoft Office applications, Adobe Acrobat, PowerPoint, and electronic document templates
- Excellent organizational and interpersonal skills
- Willingness to travel for business approximately 10%-20%
- Ability to demonstrate Elevar’s core values, including accountability, effective collaboration while working remotely, ingenuity, and compassion
Benefits
Comp & perks- Medical insurance
- Dental insurance
- Vision insurance
- Time off
- Retirement plan
- Other voluntary benefits
- Remote-based work arrangement