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

Alcedis•New York City, NY

7d•$75,000 - $95,000•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 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 for success 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 patient populations. The position offers a long-term opportunity to work from the U.S., supporting our expanding team of CRAs and PMs. 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, but we are looking for candidates based in eastern and central U.S., ideally in or around major metropolitan areas such as Boston, Chicago, Dallas, New York City, Philadelphia, or Washington, D.C.. Other locations will also be considered. Travel is not primarily planned but may be a necessary option within a project and cannot be ruled out.

Requirements

A 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 several years as a Clinical Project Manager in clinical research; experience in a CRO is a strong plus
Demonstrated ability to operate with a high degree of autonomy, including planning, prioritizing, and executing work
Hands-on experience with IRB/ethics committee submissions
Working knowledge of data privacy and protection regulations relevant to clinical trials, including HIPAA (U.S.) and FDA 21 CFR Part 11, familiarity with GDPR (EU) is a plus
Proficiency in working with electronic data and databases, along with solid skills in Microsoft Office applications
Strong sense of ownership and follow-through
Experience in roles with high autonomy and limited structure
Comfortable working without a local team or on-site management
Strong interpersonal skills and a collaborative team mindset
Excellent communication and organizational skills
Fluency in English, both written and spoken

Responsibilities

Oversee project planning and execution, including study start-up activities, ongoing study management, and coordination at all stages of the clinical trial lifecycle
Monitor project timelines and ensure adherence to the Project Plan, maintaining compliance with study objectives
Project budget responsibility and project budget controlling, reporting to the functional unit head
Co-manage IT services and platforms that support clinical trials (e.g., ePRO, eCOA, eCRF, patient engagement tools)
Translate clinical operations needs into technical requirements for internal and external IT teams
Ensure that digital tools function efficiently for both U.S. clients and patient populations
Collaborate closely with technical teams to resolve issues, implement updates, and improve workflows
Supervision and coordination of subcontractor activities
Develop and implement processes, SOPs, work instructions, and standardized documentation to ensure consistency and compliance
Creation and management of study documents (e.g., TMF, ISF) and preparation of trials
Supervision and coordination of trial sites, including communication, training, document shipping and tracking, and payment processing
Full responsibility for the preparation and execution of regulatory submissions (e.g., FDA, IRBs), including INDs, CTAs, amendments, safety reports, and more
Coordination of the project team across the various functional units and national borders (USA-Germany)