Clinical Project Manager – Clinical Research, IT

Alcedis - a HUMA company

. Lead clinical trial planning and execution across the full study lifecycle, including study start-up and ongoing study management .

Posted 10/3/2026full-timeRemote • United StatesMid-LevelSenior💰 $80,000 - $110,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading clinical trial planning and execution, including regulatory submissions and project financial management. Proficient in managing cross-functional teams and utilizing clinical trial technology to enhance study workflows.

Highest-signal resume keywords

Clinical Project ManagementRegulatory SubmissionsProject Financial ManagementCRO ExperienceData Privacy Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial PlanningStudy Documentation ManagementIRB SubmissionsBudget ControlElectronic Data ManagementSOP DevelopmentClinical Research RequirementsProject Timeline MonitoringDigital Platform ProficiencyMicrosoft Office Proficiency

Soft Skills

Interpersonal SkillsCommunication SkillsOrganizational SkillsCollaboration SkillsIndependent Work Ability

Tools & Technologies

EPROECOAECRFClinical Trial TechnologyIT Services

Industry Keywords

Clinical ResearchCROFDAHIPAAGDPRThe Belmont Report21 CFR Part 11

About the role

Key responsibilities & impact

Lead clinical trial planning and execution across the full study lifecycle, including study start-up and ongoing study management
Prepare and manage study documentation, including TMF and ISF
Monitor project timelines and ensure adherence to the Project Plan and study objectives
Own project financial management, including project budgets, budget control and reporting to the functional unit head
Lead regulatory submissions to the FDA, IRBs and other relevant authorities, including INDs, CTAs, amendments and safety reports
Coordinate cross-functional and international project teams across the U.S. and Germany
Supervise and coordinate subcontractor activities
Oversee clinical trial technology and digital platforms, including ePRO, eCOA and eCRF
Co-manage supporting IT services and ensure solutions function effectively for U.S. clients and participants
Collaborate with technical teams to resolve issues, implement updates and improve workflows
Develop and implement processes, SOPs, work instructions and standardized documentation
Coordinate clinical trial sites, including site communication, training, document shipment and tracking, and payment processing
Travel may be necessary within a project

Requirements

What you’ll need

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 clinical research
Prior CRO experience required
Hands-on experience independently managing and executing IRB/ethics committee submissions
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
Ability to work independently with limited structure and without local team members or on-site management
Proficiency with electronic data and databases
Solid proficiency in Microsoft Office
Ability to work effectively with technology and digital platforms supporting clinical research
Strong interpersonal, communication and organizational skills
Ability to collaborate across functions, teams and international borders
Fluency in written and spoken English
Candidates must be based in the Eastern or Central United States

Benefits

Comp & perks

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