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

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. 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) Qualifications and requirements From day one, we expect you to bring: • 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 Nexlith 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 Our offer • Annual salary: $75,000 – $95,000 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) • You'll work in a future-oriented and secure working environment • 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 We welcome applicants of all backgrounds and do not discriminate based on race, ethnicity, gender, sexual orientation, disability, age, religion, or any other protected characteristic. 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