Senior Clinical Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the daily planning and execution of assigned clinical trials.

• Manage clinical study vendors and oversee sponsor-related activities.

• Direct Clinical Operations and cross-functional teams throughout the trial planning, execution, and reporting phases.

• Ensure that study milestones, timelines, budgets, SOPs, ICH/GCP standards, and relevant regulations are adhered to.

• Identify, communicate, escalate, and resolve any operational challenges.

• Collaborate with Clinical Development, Data Management, Finance, Regulatory Affairs, Quality Assurance, Drug Safety and Pharmacovigilance, Clinical Supply, and clinical vendors.

• Handle study timelines, budgets, vendor selection, contracts, and expenditures.

• Ensure recruitment goals are achieved and manage enrollment reviews and contingency strategies.

• Organize internal and external team meetings, investigator meetings, and trial-specific discussions.

• Develop or facilitate the creation of Sponsor study oversight plans and associated documentation.

• Review site study documentation, investigator contracts, and site payment arrangements.

• Oversee Sponsor activities, including trip report evaluations and monitoring visits from CROs.

• Engage in the selection, training, and assessment of study personnel.

• Assist in or facilitate the training of junior members within Clinical Operations.

• Maintain an audit-ready Trial Master File and coordinate quality control during study closure.

• Support activities related to audit and inspection readiness.

• Execute other related responsibilities as assigned.

⛳️ Requirements

• BA/BS degree or equivalent experience, preferably in Life Sciences.

• A minimum of 5 years of experience in clinical trial work.

• At least 4 years of demonstrated success managing a clinical study from start to finish.

• Experience with remote or on-site monitoring is desirable.

• Acceptable CRO/industry experience.

• Familiarity with ICH/GCP guidelines and the ability to interpret and implement FDA regulations.

• Capacity to thrive in a fast-paced environment and effectively handle unexpected situations.

• Proven leadership skills and the ability to motivate cross-functional teams.

• Strong time management and project management capabilities.

• Demonstrated experience managing global clinical trials, particularly in Oncology.

• Proficient in Microsoft Office applications, Adobe Acrobat, PowerPoint, and electronic document templates.

• Excellent organizational and interpersonal skills.

• Willingness to travel for business approximately 10%-20% of the time.

• Ability to embody Elevar’s core values, which include accountability, effective collaboration in remote settings, ingenuity, and compassion.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Paid time off.

• Retirement plan.

• Additional voluntary benefits.

• Flexible remote work arrangement.