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

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.

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.

Bachelor’s degree in natural sciences, a related field, or an equivalent qualification, ideally with a medical focus; an advanced degree is preferred. You bring a proven track record of 3-5+ years of experience as a Clinical Project Manager in clinical research, with prior CRO experience required.

• Regulatory and compliance expertise

Demonstrated, hands-on experience independently managing and executing IRB/ethics committee submissions and 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.

• Strong project ownership and autonomy

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. You take ownership and consistently follow through.

• Digital and data proficiency

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.

• Collaboration and communication

Strong interpersonal, communication and organizational skills, with a collaborative mindset and the ability to work effectively across functions, teams and international borders.

• English proficiency

Fluency in written and spoken English.

• 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