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 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