Senior Clinical Trial Manager

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $170k - $187k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 3%

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Elevar Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $20M Venture Round - Elevar Therapeutics on 2018-07

Biotechnology • Pharmaceuticals • Healthcare

Elevar Therapeutics is a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. With a foundation rooted in oncology, the company is dedicated to identifying and developing promising medicines for complex and under-treated health conditions across a range of therapeutic areas. Elevar Therapeutics takes a relentless and inventive approach towards advancing next-generation therapies that aim to set new standards of care and improve patient experiences, all while maintaining the highest ethical standards.

📋 Description

• 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

• 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

• Medical insurance • Dental insurance • Vision insurance • Time off • Retirement plan • Other voluntary benefits • Remote-based work arrangement

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