Ansprechpartner
Dilsâd Babayigit
+49 (0)89 7263 210 – 00
babayigit@ageneo.de
Branche
Biotechnologie
Berufsfeld
R&D
Region
Bavaria

DAS UNTERNEHMEN

Our client is an innovative biopharmaceutical clinical-stage company in the heart of Bavaria. We are looking for a Clinical Study Lead (all genders) who will be leading a complex, global study. 

IHRE AUFGABEN

  • You oversee all operational activities related to the execution of the clinical studies from start-up to close out
  • You develop and monitor timelines and interface with the relevant functions such as Regulatory Affairs, PV and CMC
  • You develop and monitor the clinical study budget and review the incoming invoices from CRO's and other vendors according to the budget plan
  • You are responsible for the selection and qualification of CROs and other vendors for the clinical study
  • You are responsible for the management of the according CROs during the whole clinical study
  • You oversee and review clinical study protocols and other materials
  • You prepare clinical study progress reports and other reports for the management 
  • You oversee clinical distribution, supply etc.
  • You ensure the accurate tracking, reporting, compliance of clinical sites
  • You are in the overall lead for the clinical study and take ownership for the latter

IHR PROFIL

  • Bachelor degree or higher (life science, natural sciences)
  • Experience in executing and managing complex, global, clinical studies
  • Experience in selecting and managing vendors, CROs, and other service providers
  • Attention to detail without losing track of the big picture
  • Ability to work independently and self-organised
  • Fluent in English, German language skills are a plus

BENEFITS

  • highly independent mode of working
  • broad spectrum of tasks and reponsibilities 
  • innovative environment