Clinical Project Manager - Remote (U.S.)

At Alcedis, you’ll be part of our mission to accelerate the adoption of digital and AI solutions across clinical research and patient care. As a trusted contract research organization (CRO) partner to biotech, pharmaceutical, and and academic sponsors, we integrate cutting-edge technology into clinical trials to advance drug development and patient care.

Founded in 1992 and headquartered in Giessen, Germany, Alcedis brings more than 30 years of experience in clinical research. Today, we support clinical trials from Phase I through market approval as well as real-world evidence (RWE) studies, combining clinical data management and electronic data capture (EDC) with AI-driven data analytics and software platforms. Since 2023, Alcedis has been part of Huma Therapeutics. Join us, and bring your expertise, passion, creativity and drive to help us deliver on this mission.

We are looking for a Clinical Project Manager (CPM) to lead interventional and non-interventional clinical studies as well as related clinical technology initiatives. 

This role combines classic traditional clinical project management with hands-on coordination of the digital tools, eClinical platforms (such as ePRO, eCOA, and eCRF), and IT services used in patient-facing studies. You will work primarily with U.S. clients and U.S. clinical trial sites.

The position offers a long-term opportunity to work from the U.S. and support our growing team of Clinical Research Associates (CRAs) and CPMs. Because our projects span Germany, the EU, non-EU countries, and the U.S., it’s essential that you’re comfortable working across time zones and cultures.

This is a 100% remote position open to candidates based in the Eastern or Central time zones (ET/CT). We prefer candidates located in or near major metropolitan areas such as Boston, Chicago, Dallas, New York City, Philadelphia, or Washington, D.C., but we welcome applications from anywhere within these time zones. The role is not travel-based, but occasional travel may be required depending on project needs.

• Lead clinical trial planning and execution across the full study lifecycle, including study start-up, ongoing study management, preparation and management of study documentation (e.g., TMF, ISF), monitoring of project timelines, and ensuring adherence to the Project Plan and study objectives. 
• Own project financial management, including responsibility for project budgets, budget control and reporting to the functional unit head. 
• Lead regulatory submission activities, including the preparation and execution of submissions to the FDA, IRBs and other relevant authorities, such as INDs, CTAs, amendments and safety reports. 
• Coordinate cross-functional and international project teams, working across functional units and national borders (U.S.–Germany), while supervising and coordinating subcontractor activities. 
• Oversee clinical trial technology and digital platforms, including ePRO, eCOA, and eCRF; co-manage supporting IT services, ensure that solutions function effectively for U.S. clients and participants, and collaborate with technical teams to resolve issues, implement updates and continuously improve workflows. 
• Develop and implement processes, SOPs, work instructions and standardized documentation to promote consistency, efficiency and regulatory compliance across clinical trial activities. 
• Lead the coordination of clinical trial sites, including site communication, training, document shipment and tracking, and payment processing. 

What you’ll bring:

·    Education and clinical research experience 

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.

·    Regulatory and compliance expertise

Demonstrated, hands-on experience independently managing and executing IRB/ethics committee submissions and 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.

·    Strong project ownership and autonomy

Demonstrated 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. You take ownership and consistently follow through.

·    Digital and data proficiency

Comfortable working with electronic data and databases, with solid proficiency in Microsoft Office and the ability to work effectively with technology and digital platforms supporting clinical research. 

·    Collaboration and communication

Strong interpersonal, communication and organizational skills, with a collaborative mindset and the ability to work effectively across functions, teams and international borders. 

·    English proficiency

Fluency in written and spoken English. 

• Base salary: $80,000 – $110,000 per year, DOE 
• 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

Come join us! Take the next step and apply today – we can’t wait to meet you!

To apply, submit your resume directly through the link or alternatively via our careers page: Career | Alcedis. We look forward to getting to know you!

For more information about our company, please visit our website at Alcedis | Digital Clinical Trials.

Alcedis is an equal opportunity employer. We welcome applicants of all backgrounds and do not discriminate based on race, color, national origin, religion, sex (including pregnancy), sexual orientation, gender identity or expression, age, disability, genetic information, veteran status, or any other characteristic protected by federal, state, or local law.