Clinical Project Manager – Clinical Research, IT
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Job Description
Clinical Project Manager leading U.S. clinical research projects and digital trial technology for Alcedis, a contract research organization. Managing regulatory submissions, budgets, sites, and international teams.
Responsibilities:
- 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:
- 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:
- 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
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