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Clinical Project Manager (w/m/d)

Wien
Medizintechnik
Vollzeit
We are currently filling this position for our client, an innovative international company, specialised in developing and producing class 3 medical devices:


(Junior) Clinical Project Manager (w/m/d)


Your Tasks
  • Complete oversight of clinical trials
  • Monitor the progress of delegated clinical trials
  • Preparation and review of clinical study documents, like Clinical Study protocol, Investigators Brochure, Informed Consent, site contracts etc.
  • Lead and/or participate in study team meetings and writing respective Meeting Minutes
  • Preparation and submission to local ECs and/or CAs
  • Arrange and/or help in organizing clinical study meetings
  • Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial
  • Liaise with doctors, consultants or investigators on conducting the trial
  • Conduction of qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol
  • Train the site staff to trial-specific industry standards
  • Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
  • Write visit reports, file and collate trial documentation and reports
  • Attain clinical study’s goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process
  • Analysis, summary, and reporting of data for regulatory needs and/or for study data presentations

Your Profile
  • Bachelor’s degree in a related field or equivalent combination of education, training and experience
  • Experience in monitoring clinical investigations
  • Experience in early phase trials and First-In Man trials preferred
  • Knowledge of Good Clinical Practice/ICH Guidelines/ISO 14155 and other applicable regulatory requirements
  • Strong verbal and written communication skills
  • Must be fluent in English and German
  • Excellent attention to details
  • Proficient with Microsoft Office Word, Excel and PowerPoint
  • Ability to manage and prioritize workload effectively

Your Benefits
  • Central Location in 1st District of Vienna
  • International Environment
  • Workplace Well-Being
  • Possibility to work partly remote

Further information

Annual gross salary from € 50,000,- based on professional qualifications and experience.

 

 
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