[Hiring] Clinical Project Manager @Alcedis

Role Description

At Alcedis, you will be part of our mission to accelerate the adoption of digital and AI across research & care. We are looking for a Clinical Project Manager (CPM) to lead clinical research projects (interventional / non-interventional clinical studies) as well as IT-related initiatives.

• This role bridges traditional clinical project management with hands-on coordination of digital tools, platforms, and IT services used in patient-facing studies – primarily in collaboration with U.S. clients and U.S.-based participants.
• The position offers a long-term opportunity to work from the U.S., supporting our expanding team of CRAs and CPMs.
• Ability to work comfortably across time zones and cultures is essential.
• This is a 100% remote position open to candidates based anywhere in the Eastern or Central United States.
• Travel is not primarily planned but may be a necessary option within a project.

• 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.

Qualifications

• Bachelor’s degree in natural sciences, a related field, or an equivalent qualification, ideally with a medical focus; an advanced degree is preferred.
• Proven track record of 3–5+ years of experience as a Clinical Project Manager in clinical research, with prior CRO experience 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.
• 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.
• 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.
• Strong interpersonal, communication and organizational skills, with a collaborative mindset and the ability to work effectively across functions, teams and international borders.
• Fluency in written and spoken English.

Requirements

• Education and clinical research experience
• Regulatory and compliance expertise
• Strong project ownership and autonomy
• Digital and data proficiency
• Collaboration and communication
• English proficiency

Benefits

• Annual salary: $80,000 – $110,000 DOE
• 15 days of paid vacation per year
• 6 paid sick days per year
• Health, dental and vision insurance for you and your dependents
• Employee life insurance
• 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