Clinical Project Manager

🔥 6 minutes ago

🇺🇸 United States – Remote

💵 $80k - $110k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

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Alcedis - a HUMA company

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1992

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Alcedis - a HUMA company is a global contract research organization (CRO) that organizes and executes data-driven clinical studies and advances digital clinical research through proprietary technologies. It combines end-to-end clinical services — including project management, data management, monitoring, regulatory affairs, biostatistics, medical writing and pharmacovigilance — with software platforms (adaptive eCRFs, mobile apps, integrations) and AI/data-science capabilities to support biotech and pharmaceutical development from early-phase trials through regulatory approval and real-world evidence. Alcedis emphasizes technology-first, SaaS-style platforms to improve efficiency, data quality and patient-centric outcomes.

📋 Description

• Lead clinical trial planning and execution across the full study lifecycle • Manage study start-up and ongoing study management • Prepare and manage study documentation, including TMF and ISF • Monitor project timelines and ensure adherence to the Project Plan and study objectives • Own project financial management, including project budgets, budget control and reporting to the functional unit head • Lead regulatory submission activities to the FDA, IRBs and other relevant authorities, including INDs, CTAs, amendments and safety reports • Coordinate cross-functional and international project teams across U.S.–Germany borders • Supervise and coordinate subcontractor activities • Oversee clinical trial technology and digital platforms, including ePRO, eCOA and eCRF • Co-manage supporting IT services and ensure solutions function effectively for U.S. clients and participants • Collaborate with technical teams to resolve issues, implement updates and improve workflows • Develop and implement processes, SOPs, work instructions and standardized documentation • Coordinate clinical trial sites, including site communication, training, document shipment and tracking, and payment processing

🎯 Requirements

• Bachelor’s degree in life sciences, health sciences, or a related field, or equivalent experience; an advanced degree is a plus • At least 3 years of experience managing clinical trials as a Clinical Project Manager, Clinical Trial Manager, or in a comparable study management role • CRO experience is required • Demonstrated, hands-on experience independently managing and executing IRB/ethics committee submissions • Working knowledge of data privacy, protection and clinical research requirements, including The Belmont Report, HIPAA (U.S.) and FDA 21 CFR Part 11 • Familiarity with GDPR (EU) is a plus • Ability to work with a high degree of independence, including planning, prioritizing and executing work in environments with limited structure and without local team members or on-site management • Comfortable working with electronic data and databases • Solid proficiency in Microsoft Office • Ability to work effectively with technology and digital platforms supporting clinical research • Strong interpersonal, communication and organizational skills • Collaborative mindset and ability to work effectively across functions, teams and international borders • Fluency in written and spoken English • Candidates must be based in the Eastern or Central U.S. time zones (ET/CT)

🏖️ Benefits

• 15 days of paid vacation per year • Paid holidays • At least 6 paid sick days per year, or more where required by state or local law • Health, dental and vision insurance for you and your dependents • Employee life insurance • Short term disability • Long term disability • Health Savings Account (HSA) • 401(K) (no employer match) • A forward-looking, growth-oriented work environment • Exciting and challenging projects that make an impact • Flat organizational structure with an open and collaborative culture • A dedicated, successful, and supportive team environment • Varied work with the autonomy to take ownership of your projects • Flexible working hours to support work-life balance

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