Senior Clinical Trial Manager

Job not on LinkedIn

🔥 16 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $171k - $189k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Atrium Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2026

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Atrium Therapeutics is a clinical-stage biotechnology company developing precision RNA medicines targeted to the heart. The company has a proprietary RNA delivery platform built on clinically validated AOC (antibody-oligonucleotide conjugate) technology originally designed at Avidity Biosciences, enabling delivery of oligonucleotide therapies directly into cardiac muscle while addressing cytotoxicity, immunogenicity, and redosing limitations. Atrium's pipeline includes lead candidates ATR-1072 for PRKAG2 syndrome and ATR-1086 for PLN cardiomyopathy, plus additional research-stage targets in rare cardiomyopathies; the company plans to file an IND for ATR-1072 in the second half of 2026. Atrium positions itself to pioneer precision cardiology by bringing RNA therapeutics to patients with genetic and rare forms of heart disease.

📋 Description

• Accountable for overall clinical study operations, including CRO and vendor management, project plans, budgets, and resource management • Lead development of study operational plans and contribute to functional area plans and processes • Oversee CROs, vendors, and sites while ensuring GCP and regulatory compliance • Represent clinical operations in cross-functional teams • Develop and manage study timelines and budgets with the Clinical Operations Lead, internal leadership, and CROs • Manage clinical study vendors and establish deliverables and KPIs • Develop study-specific training for site staff, CRAs, and vendors and present at Investigator and Kick-off meetings • Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies to meet timelines and ensure quality deliverables • Manage and oversee eTMF structure, plans, and quality • Manage investigator selection, drug supply projections, study start-up, recruitment and retention, data collection, database locks, drug accountability, and study closeout • Contribute to clinical trial outlines, protocols, informed consent forms, and clinical study reports • Lead or collaborate on project plans, training, system builds, CRF designs, and UATs • Identify and resolve issues and risks with cross-functional teams and service providers • Collaborate with data management and CRAs to ensure data quality and cleaning timelines • Perform clinical data review, including query generation, as needed • Contribute to process improvements, initiatives, and SOPs • Provide direction and mentoring to junior team members • Escalate CRA performance and site compliance issues • May have line management responsibilities

🎯 Requirements

• Bachelor’s degree required, preferably in the Life Sciences or equivalent • Minimum of 8-10 years of experience in clinical operations is required • Experience managing a CRO and a complex study in a previous Clinical Trial Manager or equivalent position • Global Clinical Trial experience in Phase I-III • Experience in Rare Disease required; cardiovascular experience is a plus • Inspection readiness and inspection experience is a plus • Exceptional attention to detail and organizational skills • Excellent oral and written communication, analytical, and project management skills • Ability to develop and maintain strong, collaborative relationships with key internal and external stakeholders • Ability to multitask, deal with conflict and obstacles, and work in a fast-paced environment • Ability to quickly learn and use technical applications • Preferred experience using Smartsheet/MS Excel or equivalent • Ability to manage budgets and forecast • Prior auditing experience preferred • Prior experience working as a Clinical Research Associate (CRA) preferred • In-depth knowledge of ICH/GCP, regulatory guidelines/directives, drug development, and clinical research processes • Team leadership experience within a cross-functional matrix environment • Ability to travel nationally and globally for meetings and conferences, approximately 10%-15%

🏖️ Benefits

• Stock options • 401(k) with an employer match • Medical coverage • Dental coverage • Vision coverage • LTD coverage • Unlimited time off, including summer & winter breaks • Internally developed learning and development programming • Job-specific training offered by industry • Education reimbursement program