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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