Clinical Project Manager

Alcedis - a HUMA company

. Lead clinical trial planning and execution across the full study lifecycle .

Posted 11/12/2026full-timeRemote • United StatesMid-LevelSenior💰 $80,000 - $110,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, including planning, execution, and regulatory submissions. Proficient in managing project budgets, timelines, and cross-functional teams while ensuring compliance with clinical research regulations.

Highest-signal resume keywords

Clinical Trial ManagementRegulatory Submission ActivitiesProject Financial ManagementCRO ExperienceData Privacy and Protection Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial PlanningStudy Documentation ManagementIRB Submission ManagementBudget ControlProject Timeline MonitoringSOP DevelopmentElectronic Data ManagementClinical Research Requirements KnowledgeMicrosoft Office ProficiencyDigital Platforms for Clinical Research

Soft Skills

Interpersonal SkillsCommunication SkillsOrganizational SkillsCollaborative MindsetAbility to Work Independently

Tools & Technologies

EPROECOAECRFClinical Trial TechnologyIT Services for Clinical Research

Industry Keywords

Clinical ResearchFDA RegulationsHIPAA ComplianceGDPR FamiliarityThe Belmont Report

About the role

Key responsibilities & impact

Lead clinical trial planning and execution across the full study lifecycle
Manage 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 submission activities to the FDA, IRBs and other relevant authorities, including INDs, CTAs, amendments and safety reports
Coordinate cross-functional and international project teams across U.S.–Germany borders
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

Requirements

What you’ll need

Bachelor’s degree in life sciences, health sciences, or a related field, or equivalent experience; an advanced degree is a plus
At least 3 years of experience managing clinical trials as a Clinical Project Manager, Clinical Trial Manager, or in a comparable study management role
CRO experience is required
Demonstrated, 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 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
Comfortable working 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
Collaborative mindset and ability to work effectively across functions, teams and international borders
Fluency in written and spoken English
Candidates must be based in the Eastern or Central U.S. time zones (ET/CT)

Benefits

Comp & perks

15 days of paid vacation per year
Paid holidays
At least 6 paid sick days per year, or more where required by state or local law
Health, dental and vision insurance for you and your dependents
Employee life insurance
Short term disability
Long term disability
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