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• 

  Study Start-up Manager (m/f/x)  

  Next Research GmbH

  Permanent - Wien

  Gepostet: 05/05/2026

  Jetzt bewerben

  A dynamic international contract research organisation seeks a highly... mehr ansehen

  A dynamic international contract research organisation seeks a highly motivated candidate to join its team.

  Study Start-up Manager
  Immediate start

  As Study Start-up Manager, you will drive the initiation phase of clinical studies in the field of minimally invasive, image-guided therapies. You will be responsible for the efficient and compliant set-up of clinical research projects, from protocol finalisation through site activation and regulatory approvals, and ensure a seamless transition into the study execution phase.

  You will act as a central interface between cross-functional teams, investigators, and external stakeholders during start-up, and contribute to the development of robust, scalable processes within Next Research.

  You will work closely with principal investigators, study steering committees, and internal teams, ensuring that all start-up activities are conducted in compliance with Good Clinical Practice and international standards such as ISO 14155.

  
  Aufgaben

  Study Start-up Management

  • Lead all aspects of study start-up, including protocol (CIP) finalisation, feasibility assessments, site selection, and site activation
  • Develop and maintain start-up timelines and ensure timely study initiation
  • Coordinate and execute regulatory and ethics submissions in collaboration with relevant stakeholders

  Cross-functional Collaboration

  • Work closely with Data Management, Project Management, and other internal teams to ensure efficient study initiation
  • Ensure structured and effective handover to the Project Management team once enrolment begins
  • Facilitate communication of study start-up progress to internal and external stakeholders

  Study Design & Documentation

  • Contribute to study design in collaboration with cross-functional teams and Steering Committees
  • Develop and maintain key study documents (e.g. CIP, CRFs, ICFs)
  • Ensure all documentation is consistent, feasible, and aligned with study objectives
  • Ensure compliance with GCP, ISO 14155, and applicable regulatory requirements

  Stakeholder Engagement

  • Liaise with investigators, study sites, regulatory authorities, and ethics committees
  • Support and guide sites and stakeholders through start-up processes
  • Provide regular updates to internal stakeholders and senior management

  
  Profil

  • University degree in a relevant healthcare or scientific field
  • 3-5 years of clinical research project management experience
  • Familiarity with GCP, ISO 14155 and regulatory/ethics submission processes
  • Strong organisational and coordination skills with attention to detail
  • Ability to manage multiple parallel start-up activities and stakeholders
  • Excellent written and verbal communication skills in English
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint)

  
  Wir bieten

  Next Research is based in Vienna's 1st district and offers a friendly and open working atmosphere in an exciting and dynamic field of medicine as well as a fair payment scheme and travel opportunities (approx. 2-3 times annually). The minimum starting salary is € 3200 - negotiable depending on additional qualifications and relevant work experience.

  
  

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• 

  Study Start-up Manager (m/f/x)  

  Next Research GmbH

  Feste Anstellung - Wien

  Gepostet: 28/04/2026

  Jetzt bewerben

  A dynamic international contract research organisation seeks a highly... mehr ansehen

  A dynamic international contract research organisation seeks a highly motivated candidate to join its team.

  Study Start-up Manager
  Immediate start

  As Study Start-up Manager, you will drive the initiation phase of clinical studies in the field of minimally invasive, image-guided therapies. You will be responsible for the efficient and compliant set-up of clinical research projects, from protocol finalisation through site activation and regulatory approvals, and ensure a seamless transition into the study execution phase.

  You will act as a central interface between cross-functional teams, investigators, and external stakeholders during start-up, and contribute to the development of robust, scalable processes within Next Research.

  You will work closely with principal investigators, study steering committees, and internal teams, ensuring that all start-up activities are conducted in compliance with Good Clinical Practice and international standards such as ISO 14155.

  
  

  Study Start-up Management

  • Lead all aspects of study start-up, including protocol (CIP) finalisation, feasibility assessments, site selection, and site activation
  • Develop and maintain start-up timelines and ensure timely study initiation
  • Coordinate and execute regulatory and ethics submissions in collaboration with relevant stakeholders

  Cross-functional Collaboration

  • Work closely with Data Management, Project Management, and other internal teams to ensure efficient study initiation
  • Ensure structured and effective handover to the Project Management team once enrolment begins
  • Facilitate communication of study start-up progress to internal and external stakeholders

  Study Design & Documentation

  • Contribute to study design in collaboration with cross-functional teams and Steering Committees
  • Develop and maintain key study documents (e.g. CIP, CRFs, ICFs)
  • Ensure all documentation is consistent, feasible, and aligned with study objectives
  • Ensure compliance with GCP, ISO 14155, and applicable regulatory requirements

  Stakeholder Engagement

  • Liaise with investigators, study sites, regulatory authorities, and ethics committees
  • Support and guide sites and stakeholders through start-up processes
  • Provide regular updates to internal stakeholders and senior management

  
  

  • University degree in a relevant healthcare or scientific field
  • ~3-5 years of clinical research project management experience
  • Familiarity with GCP, ISO 14155 and regulatory/ethics submission processes
  • Strong organisational and coordination skills with attention to detail
  • Ability to manage multiple parallel start-up activities and stakeholders
  • Excellent written and verbal communication skills in English
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint)

  
  

  Next Research is based in Vienna's 1st district and offers a friendly and open working atmosphere in an exciting and dynamic field of medicine as well as a fair payment scheme and travel opportunities (approx. 2-3 times annually). The minimum starting salary is € 3200 - negotiable depending on additional qualifications and relevant work experience.

  
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• N

  Study Start-Up Manager (M/F/X)  

  Next Research GmbH

  - Wien, Innere Stadt

  Gepostet: 14/04/2026

  Jetzt bewerben

  A dynamic international contract research organisation seeks a highly... mehr ansehen

  A dynamic international contract research organisation seeks a highly motivated candidate to join its team. Study Start-up Manager Immediate start As Study Start-up Manager, you will drive the initiation phase of clinical studies in the field of minimally invasive, image-guided therapies. You wi... Original Stellenanzeige auf StepStone.At – Jetzt Jobagent bei StepStone einrichten und Traumjob finden! Mehr Informationen zu Arbeitgebern, Gehaltsdaten und Karrieretipps finden Sie auf StepStone.At WHJS1_AT weniger ansehen

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