Alcedis - a HUMA company · 1 day ago
Clinical Project Manager (Research & IT) – Home-Based (Eastern & Central U.S.)
United States
Full-time
Remote
Mid, Senior Level
$75K/yr - $95K/yr
4+ years expAlcedis, a HUMA company, is dedicated to accelerating the adoption of digital and AI across research and care. They are seeking a Clinical Project Manager to lead clinical research projects and IT-related initiatives, ensuring efficient project execution and coordination of digital tools for patient-facing studies.
Clinical TrialsHealth CareMedicalSoftware
Responsibilities
Oversee project planning and execution, including study start-up activities, ongoing study management, and coordination at all stages of the clinical trial lifecycle
Monitor project timelines and ensure adherence to the Project Plan, maintaining compliance with study objectives
Project budget responsibility and project budget controlling, reporting to the functional unit head
Co-manage IT services and platforms that support clinical trials (e.g., ePRO, eCOA, eCRF, patient engagement tools)
Translate clinical operations needs into technical requirements for internal and external IT teams
Ensure that digital tools function efficiently for both U.S. clients and patient populations
Collaborate closely with technical teams to resolve issues, implement updates, and improve workflows
Supervision and coordination of subcontractor activities
Develop and implement processes, SOPs, work instructions, and standardized documentation to ensure consistency and compliance
Creation and management of study documents (e.g., TMF, ISF) and preparation of trials
Supervision and coordination of trial sites, including communication, training, document shipping and tracking, and payment processing
Full responsibility for the preparation and execution of regulatory submissions (e.g., FDA, IRBs), including INDs, CTAs, amendments, safety reports, and more
Coordination of the project team across the various functional units and national borders (USA-Germany)
Qualification
Required
A Bachelor's degree in natural sciences, a related field, or an equivalent qualification — ideally with a medical focus; an advanced degree is preferred
Proven track record of several years as a Clinical Project Manager in clinical research; experience in a CRO is a strong plus
Demonstrated ability to operate with a high degree of autonomy, including planning, prioritizing, and executing work
Hands-on experience with IRB/ethics committee submissions
Working knowledge of data privacy and protection regulations relevant to clinical trials, including HIPAA (U.S.) and FDA 21 CFR Part 11, familiarity with GDPR (EU) is a plus
Proficiency in working with electronic data and databases, along with solid skills in Microsoft Office applications
Strong sense of ownership and follow-through
Experience in roles with high autonomy and limited structure
Comfortable working without a local team or on-site management
Strong interpersonal skills and a collaborative team mindset
Excellent communication and organizational skills
Fluency in English, both written and spoken
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)
You'll work in a future-oriented and secure working environment
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
Company
Alcedis - a HUMA company
With over 30 years of experience, Alcedis combines medical expertise with ground-breaking technologies to pioneer data-driven clinical research.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2023-01-09Acquired
Leadership Team
Diana Zanger
Employee Experience
Hanno Härtlein
Managing Director
Company data provided by crunchbase