Biologe (m/w/d)
Core
Managing and coordinating clinical trials from planning to completion, ensuring regulatory compliance and team alignment.
Role type
Clinical Trial Project Manager
Builds
Clinical trial execution and regulatory submissions
Domain
Healthcare / Clinical Research
Deliverable
client delivery
Required skills
Clinical trial project management, knowledge of drug regulations (AMG), regulatory submissions, team coordination, protocol development, timeline and budget management, quality assurance
Preferred skills
Experience with medicinal product or medical device studies, scientific problem-solving interest
Technologies
MS Office
Responsibilities
Coordinate planning, initiation, execution, and closure of clinical trials; Act as central contact for internal and external stakeholders; Lead study teams (monitoring, biometrics, safety, data management); Communicate with study leadership and centers; Plan tasks and monitor timelines/budgets; Create study protocols and documents; Handle regulatory submissions; Ensure project quality and escalate issues; Develop and maintain process quality (SOPs, manuals)