Clinical Project Manager – Clinical Research, IT

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

📋 Description

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

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

• Monitor project timelines to ensure compliance with the Project Plan and study objectives.

• Take charge of project financial oversight, encompassing budgets, budget management, and reporting to the head of the functional unit.

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

• Coordinate cross-functional and international project teams based in the U.S. and Germany.

• Supervise and manage the activities of subcontractors.

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

• Co-manage supporting IT services and ensure efficient functionality of solutions for clients and participants in the U.S.

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

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

• Coordinate clinical trial sites, managing site communication, training, document shipping and tracking, and payment processing.

• Travel may be required as part of project responsibilities.

⛳️ 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 realm of clinical research.

• Prior experience with a Contract Research Organization (CRO) is essential.

• Practical experience in independently managing and executing IRB/ethics committee submissions.

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

• Familiarity with the General Data Protection Regulation (GDPR) (EU) is an advantage.

• Capability to work autonomously with minimal structure and without local team members or on-site management.

• Proficient in electronic data management and databases.

• Strong competency in Microsoft Office applications.

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

• Excellent interpersonal, communication, and organizational skills.

• Ability to collaborate across functions, teams, and international boundaries.

• Proficiency in both written and spoken English.

• Candidates must be located in the Eastern or Central United States.

🏝️ 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, growth-oriented work environment.

• Engaging and challenging projects that create a meaningful impact.

• A flat organizational structure fostering an open and collaborative culture.

• A dedicated, successful, and supportive team atmosphere.

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

• Flexible working hours to promote a healthy work-life balance.