Regulatory & Study Start-up Specialist (M/w/d)

vor 1 Woche

Wien, Österreich IQVIA Vollzeit

We currently offer an exciting opportunity as **Regulatory & Start-Up Specialist (m/w/d)** to work in both fields of _ethics and submissions_ and _contracting and budget negotiations_ in our Country Site Activation Department. You can work in our Vienna office, alternatively you can work home-based as well. A specialization in contracting and budgets would be possible as well.

**While projects vary, your typical responsibilities might include**:

- Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines. Where applicable, act as a Country Lead for projects with no regional Lead assigned.
- Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
- Review, prepare and negotiate site contracts and budgets with sites.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Distribute completed documents to sites and internal project team members.
- Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP Release documents, in line with project timelines.
- Perform quality control of documents provided by sites.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Ensure regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.

**You should have**:

- Bachelor's Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience
- 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience
- Fluent languages skills in German on at least C1 level and good command of English
- Effective communication, organizational and planning skills
- Ability to work independently and to effectively prioritize tasks
- Ability to work on multiple projects
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Knowledge of applicable regulatory requirements, including local regulations,, SOPs and company’s Corporate Standards.
- Understanding of regulated clinical trial environment and knowledge of drug development process.

We invite you to join IQVIA.

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