Clinical Project Manager (Clinical Research & IT) – Home-Based (Eastern & Central U.S.)

Alcedis•Boston, MA

18d•Remote

About The Position

At Alcedis, you will be part of our mission to accelerate the adoption of digital and AI across research & care. As a trusted contract research organization (CRO) and partner to biotechs, pharma, and academia, we integrate cutting-edge technology into clinical trials to advance drug development and patient care. Join us, and bring your expertise, passion, creativity, and strong willingness to succeed to realize this mission. 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. Because our projects span Germany, the EU, non-EU countries, and the U.S., the 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. Candidates located in or around major metropolitan areas such as Boston, Chicago, Dallas, New York City, Philadelphia, or Washington, D.C. are preferred, but other locations within these time zones will also be considered. Travel is not primarily planned but may be a necessary option within a project and cannot be ruled out.

Requirements

Bachelor’s degree in natural sciences, a related field, or an equivalent qualification, ideally with a medical focus.
Proven track record of 3–5+ years of experience as a Clinical Project Manager in clinical research.
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.
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.
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 the ability to work effectively across functions, teams and international borders.
Fluency in written and spoken English.

Nice To Haves

An advanced degree is preferred.
Familiarity with GDPR (EU) is a plus.

Responsibilities

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.