Beschreibung

As a Clinical Trial Manager, you will play a crucial role in overseeing trial operations, managing budgets, and ensuring project timelines are met. Your day-to-day responsibilities will involve coordinating with teams, reviewing essential documents, and addressing any challenges that arise during the trial process.

Anforderungen

• •Natural/life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant)
• •Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for clinical research projects
• •Minimum 3 years of experience in project management, regulatory submissions, monitoring of clinical trials or clinical trial coordination
• •Refined colloquial and correspondence skills (written and spoken)
• •Very good English (written and spoken)
• •Experience in usual software (Word, Excel, Power Point, MS Project)
• •Ability to recognize problems and provide solutions
• •Good organizational and communicative skills
• •Pro-active way of working, used to work independently and ready to take over responsibility

Aufgaben

• •Support preparation of regular status reports
• •Present project status in meetings
• •Oversee the clinical trial budget
• •Communicate with Project Manager and Associate Director about project plan divergences
• •Monitor project timelines and deliverables
• •Set up and oversee study-related documents like Trial Management Plan and Monitor Manual
• •Contribute to and review core study documents, including synopsis and patient informed consent
• •Coordinate project activities with internal departments and external vendors from start to finish
• •Instruct and supervise CTCs, CRAs, and CTAs within the project scope
• •Act as the point of contact for issues within the clinical trial
• •Support planning and conduct of project training before starting activities

Tools & Technologien