Alcedis - a HUMA company

Clinical Operations

• 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

Clinical Project Manager – Clinical Research, IT

Clinical Research

• Support the organization and conduct of clinical trials at investigative sites
• Manage relationships with investigators and obtain and document study status updates
• Prepare, conduct, and follow up on site initiation, monitoring, and close-out visits—on-site or remotely—including report preparation
• Conduct feasibility assessments for new projects
• Validate study data as part of source data verification
• Verify that investigative sites comply with applicable guidelines and legal requirements
• Support audits and inspections at investigative sites
• Raise study data queries, coordinate them with relevant contacts, and monitor the query process
• Work closely with Data Management and Project Management
• Train investigators and study coordinators on the use of EDC software
• Serve as the liaison between investigative sites, Project Management, and other involved teams
• Prepare study documents, including shipment and tracking, or support these activities
• Prepare documentation for submissions to regulatory authorities and ethics committees
• Independently manage the Southern Germany region
• Visit investigative sites on a regular basis; travel approximately 30–40%

Clinical Research Associate, Clinical Monitor, Site Manager

• Join Alcedis’s U.S.-based expert network of clinical research professionals
• Support current and future clinical studies based on project needs and mutual availability
• Conduct and support Site Initiation Visits, primarily virtually, in the U.S. and Canada
• Perform on-site and remote monitoring activities
• Work within the Clinical Operations team as a part-time project-based employee
• Collaborate with colleagues across U.S. and European time zones, including Germany
• Discuss study scope, timing, workload, and availability when a suitable project becomes available
• Support projects primarily focused on Oncology and Alzheimer’s disease, with additional therapeutic areas expected

Clinical Research Associate – U.S. Expert Network

• Support the organization and conduct of clinical trials at investigational sites
• Provide support to investigators
• Request and document study status updates
• Prepare, conduct, and follow up on initiation, monitoring, and close-out visits, either on-site or remotely
• Prepare visit reports
• Conduct feasibility assessments for new projects
• Validate study data collected by investigators through source data verification
• Verify that investigational sites comply with applicable guidelines and legal requirements
• Support audits and inspections at investigational sites
• Create and monitor queries related to study data
• Coordinate with relevant stakeholders and work closely with Data Management and Project Management
• Train investigators and study coordinators on the use of EDC software
• Serve as the interface between investigational sites, Project Management, and other involved teams
• Support the preparation, distribution, and tracking of study documents
• Prepare documents for submissions to regulatory authorities and ethics committees
• Regular on-site work at investigational sites, with approximately 30–40% travel
• Independently manage the Southern Germany region

Clinical Project Manager – Clinical Research, IT

Clinical Research Associate, Clinical Monitor, Site Manager

Clinical Research Associate – U.S. Expert Network

Clinical Research Associate – Clinical Monitor – Site Manager