Alcedis - a HUMA company

Clinical Operations

• Independent and accountable project planning and end-to-end project execution
• Coordination of the project team across multiple functional units and countries
• Primary contact for the client
• Oversight of global vendor management (partner CROs)
• Training and support of the project support team

Clinical Project Manager

• Independent responsibility for managing clinical drug trials, non-interventional studies (NIS), and medical device studies
• End-to-end project planning and execution
• Coordination and leadership of the project team across multiple functional units and countries
• Primary client contact
• Management of global vendor relationships (partner CROs)
• Training and support for the project support team

Clinical Project Manager, Clinical Trials

Software Engineer

• Develop Python-based applications in the area of NLP
• Process and prepare data
• Build automation projects using Python or common low-code tools such as n8n

Working Student, AI-driven Software Development

• Erstellung von Studienunterlagen
• Studienvorbereitung (Vertragsmanagement, Erstellung von Printmaterialien, Organisation von Studientreffen)
• Erstellung und Verwaltung des Trial Master File
• Betreuung der Studienzentren (Kommunikation, Schulungen, Versand von Unterlagen)
• Unterstützung des Projektleiters bei der Archivierung

Studentische Aushilfe – Klinische Forschung, Clinical Operations

• Support in organizing the study at investigational sites and in managing investigators
• Query study status at investigational sites (following a predefined guide) and document findings
• Train investigators and site coordinators on the study and on the EDC software
• Conduct feasibility assessments for new projects with investigational sites
• Support the preparation of study documents, including shipping and tracking
• Prepare documents for submission to regulatory authorities and ethics committees
• Create and maintain the Study Master File (SMF)
• Support sites in addressing queries related to electronically captured study data
• Correspondence (using templates or independently, in German and English)
• Shipping and tracking of documents and study materials to investigational sites
• Drafting/editing study contracts (according to templates/guidance)
• Prepare documentation for site remuneration/payment
• Organize investigator meetings
• Prepare presentations, charts and tables (independently and per instruction)
• Provide support to the project support team

Clinical Project Manager

Clinical Project Manager, Clinical Trials

Working Student, AI-driven Software Development

Studentische Aushilfe – Klinische Forschung, Clinical Operations

Project Assistant – Clinical Studies