BioNTech SE
Associate Director Clinical Trials(m/w/x)
Vollzeit
Senior
Keine Angabe
Mainz
BI
BioNTech SE2 Monate
Manager Clinical Trials(m/w/x)
Vollzeit
Berufserfahren
Keine Angabe
Mainz
Nejo KI-Zusammenfassung
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.
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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
Bachelor-Abschluss
Berufserfahrung
3 Jahre
Deine 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
WordExcelPower PointMS Project
Sprachen
Englisch – verhandlungssicher
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