Biologe (m/w/d)
Core
Coordinating multi-center clinical trial projects and managing logistics for investigational medicinal products in oncology research.
Role type
Clinical Trial Manager (Project Manager) or Assistant
Builds
Clinical trials for academic and industry collaboration
Domain
Oncology / Clinical Research
Deliverable
client delivery
Required skills
Clinical trial coordination, regulatory compliance (AMG, GCP, CTR), protocol development, site management, document creation, data management collaboration, safety reporting, logistics planning
Preferred skills
Academic research experience, project management in clinical trials
Technologies
Electronic Trial Master File, Case Report Forms, Pharmacy Folders
Responsibilities
Planning, organizing, and executing clinical trials; Contributing to study protocol and submission document creation; Communicating with authorities and ethics committees; Creating patient information and study-specific documents; Selecting, supporting, and managing trial sites; Organizing study initiation and closure; Maintaining Investigator Site Files and Pharmacy Folders; Developing and testing Case Report Forms; Organizing and documenting meetings (e.g., DSMB, risk analyses); Creating safety reports (ASRs) and regulatory reports; Supporting data analysis and publication; Maintaining Trial Master File; Preparing presentations and study reviews; Developing and supporting the collection of biological samples; Planning and monitoring logistics of study medication