Remote Senior Clinical Trial Manager

Elevar Therapeutics, Inc.; United States; Remote; USD 170,000 - 187,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Time off & benefits

Job summary

Elevar Therapeutics, Inc. is seeking a Senior Clinical Trial Manager for a remote-based role in the United States.

The candidate will oversee day-to-day planning and execution of clinical trials, including vendor oversight, sponsor oversight, and data quality, ensuring milestones are met in compliance with ICH/GCP and regulatory requirements. Responsibilities include leading the Clinical Operations team, coordinating cross-functional stakeholders, managing timelines and budgets, and ensuring

Qualifications

• BA/BS degree or equivalent years of experience.
• At least 5+ years of clinical trial work experience, with a minimum of 4 years managing a trial from inception to completion (remote or on-site monitoring acceptable).
• Knowledge of ICH/GCP guidelines and FDA regulations.
• Ability to work in a fast-paced environment and handle 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 templates.
• Excellent organizational and interpersonal skills.
• Willingness to travel ~10–20%.
• Ability to embody Elevar’s core values in remote collaboration.

Responsibilities

• Collaborate with project team members and Finance to manage trial vendors to meet timelines and deliverables.
• Lead the Clinical Operations team and cross-functional trial team to plan, execute, and report trials in alignment with timelines, budgets, SOPs, ICH/GCP, and regulatory requirements.
• Identify and resolve operational issues to ensure milestones, data quality, and data integrity; escalate as needed.
• Coordinate with Clinical Development, Data Management, Regulatory, QA, Drug Safety, and vendors to support trial activities.
• Manage study timelines and budgets, select and manage vendors, and monitor expenditures within budget.
• Ensure recruitment targets are met and review enrollment at site level; coordinate contingency plans if targets are not met.
• Organize meetings including investigator meetings; facilitate sponsor oversight discussions and site documentation reviews.
• Participate in training and evaluation of study personnel to ensure efficient operation of the function.
• Support TMF documentation readiness and audit readiness at study closure.
• Assist in audit and inspection readiness activities.

Skills

Leadership

Project management

GCP/ICH knowledge

Communication

Time management

Education

BA/BS degree or equivalent

Tools

MS Office

Adobe Acrobat

Job description

Elevar Therapeutics, Inc. is seeking a Senior Clinical Trial Manager for a remote-based role in the United States.

The candidate will oversee day-to-day planning and execution of clinical trials, including vendor oversight, sponsor oversight, and data quality, ensuring milestones are met in compliance with ICH/GCP and regulatory requirements. Responsibilities include leading the Clinical Operations team, coordinating cross-functional stakeholders, managing timelines and budgets, and ensuring