Study Startup Specialist Ii

Vor 6 Tagen


Wien, Österreich PSI CRO Vollzeit

**Company Description**
We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time.

Hybrid working arrangement in Vienna, Austria

**You will**:

- Collaborate with the project team for site activation processes
- Assist in feasibility research and site identification
- Facilitate site agreement and budget negotiations
- Collect site documents for IRB/IEC submission and/or IP-RED process
- Coordinate translation and review of study-specific documents
- Identify and escalate project-specific issues as needed
- Prepare and submit the study dossiers to sites, competent authorities, IRBs/IECs
- Prepare IP-REDs packages
- Support initial distribution of Investigational Product(s) and clinical study supplies to sites
- Ensure exchange of information and documentation with investigational sites, off site facilities and vendors
- Participate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets
- Train and coach department staff on startup processes

**Qualifications**
- College/University degree in Life Sciences or an equivalent combination of education, training and experience
- At least 2 years of full-scope Study Startup experience in the country/region
- Full working proficiency in English
- Well-developed communication and organizational skills
- Ability to negotiate and build relationships at all levels

**Additional Information**
Advance your career in clinical research, overseeing a variety of tasks and growing with the company. You will work closely with driven and dedicated cross-functional teams, get all support and ownership of your projects.
- Excellent working conditions
- Extensive training and friendly, collegial team
- Opportunities for personal and professional growth
- A fair and attractive salary and benefits package starting at EUR 62.000 gross. The precise salary depends on the specific qualifications and experience, and will be agreed upon on an individual basis



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