Clinical Trial Manager

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🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $140k - $148k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• End-to-end oversight of start-up and clinical responsibilities—from site identification through to database lock • Ensure start-up and clinical project plans address identified risks while adhering to professional standards, SOPs, client, and regulatory requirements • Proactively identify and address start-up and clinical project, financial, and quality risks • Responsible for financial aspects of clinical and start-up activities, including revenue forecasting • Ensure project team awareness and tracking of Key Project Indicators (KPI) • Develop and implement the site activation and recruitment strategy in collaboration with project teams • Lead and oversee site identification and site selection • Oversight of Informed Consent Form development and translations • Oversight of essential document creation and collection • Lead the end-to-end process of regulatory/ethics committee submissions and approvals • Ensure clinical supplies are in place as applicable • Manage operational aspects to support subject recruitment and retention • Ensure inspection-readiness through quality oversight of TMF, monitoring reports, protocol deviations and issue management • Foster effective communication and collaboration with clients and cross-functional project teams in a global environment.

🎯 Requirements

• University/college degree (life science preferred) or certification in a related allied health profession • Four or more years of relevant clinical research experience in pharmaceutical, CRO, or health care setting • Previous SSU and Clinical Trial Lead experience • Comprehensive knowledge of GCP, ICH, and regulatory guidelines • Proficiency in Microsoft Office and familiarity with EDC, CTMS, eTMF, and vendor platforms (e.g. Veeva Vault, Medidata) • Effective leadership in remote and global environment • Strong communication, planning, and organizational abilities • Proven team motivational skills • Proficiency in balancing concurrent tasks within time-sensitive environments • Financial awareness and use of tracking systems/tools • Demonstrated independent problem-solving and risk management mindset • Demonstrated professional client interaction and presentation skills.

🏖️ Benefits

• Remote-based work • Travel requirements: up to 20% (global – primarily domestic and international)