Clinical Project Manager – Clinical Research, IT

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the planning and execution of clinical trials throughout the entire study lifecycle, encompassing study initiation and continuous management.

• Prepare and handle study documentation, including Trial Master File (TMF) and Investigator Site File (ISF).

• Track project timelines and ensure compliance with the Project Plan and study goals.

• Manage project finances, including project budgets, budget oversight, and reporting to the head of the functional unit.

• Lead regulatory submission processes to the FDA, Institutional Review Boards (IRBs), and other pertinent authorities, covering Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), amendments, and safety reports.

• Coordinate cross-functional and international project teams operating across U.S.–Germany borders.

• Supervise and manage the activities of subcontractors.

• Oversee clinical trial technologies and digital platforms, such as electronic Patient Reported Outcomes (ePRO), electronic Clinical Outcome Assessments (eCOA), and electronic Case Report Forms (eCRF).

• Co-manage supporting IT services to ensure effective functionality for U.S. clients and participants.

• Collaborate with technical teams to troubleshoot issues, implement updates, and enhance workflows.

• Develop and execute processes, Standard Operating Procedures (SOPs), work instructions, and standardized documentation.

• Lead the coordination of clinical trial sites, including site communication, training, document shipping and tracking, as well as payment processing.

⛳️ Requirements

• A Bachelor’s degree in natural sciences, a related field, or an equivalent qualification; an advanced degree is preferred.

• 3–5+ years of experience as a Clinical Project Manager in the field of clinical research.

• Previous experience in a Contract Research Organization (CRO) is mandatory.

• Practical experience in independently managing and executing submissions to IRBs and ethics committees.

• In-depth knowledge of data privacy, protection, and clinical research regulations, including The Belmont Report, HIPAA (U.S.), and FDA 21 CFR Part 11.

• Familiarity with General Data Protection Regulation (GDPR) in the EU is a plus.

• Capability to work autonomously, including planning, prioritizing, and executing tasks in environments with limited structure and without local team members or on-site management.

• Comfortable with electronic data and database management.

• Strong proficiency in Microsoft Office applications.

• Ability to effectively utilize technology and digital platforms that support clinical research.

• Excellent interpersonal, communication, and organizational skills.

• Collaborative attitude and capacity to work efficiently across functions, teams, and international borders.

• Proficient in written and spoken English.

🏝️ Benefits

• 15 days of paid vacation annually.

• 6 paid sick days each year.

• Health, dental, and vision insurance for you and your dependents.

• Employee life insurance coverage.

• Health Savings Account (HSA).

• 401(K) plan (without employer match).

• A progressive and growth-focused work environment.

• Engaging and challenging projects that have a meaningful impact.

• A flat organizational structure that promotes an open and collaborative culture.

• A dedicated, successful, and supportive team atmosphere.

• Diverse work with the freedom to take ownership of your projects.

• Flexible working hours to enhance work-life balance.