Study Start Up Specialist
- Experience Level
- Experienced (non-manager)
Josh Zarembski is looking for the very first Country Study Start-up Specialist to join a growing mid-size life science organisation based in the Milan area.
This organisation still maintains a close family-style environment and look to see the person behind every number. With 25% of their staff being promoted annually, this is not just a position for the here and now but a fantastic opportunity for future progression.
In this role, you will provide support with Regulatory Affairs, Project Management and the Legal Team in the Study Start-up-phase and in case of Amendment submissions for Clinical Trials and Real World Evidence (RWE) studies. Assisting with local regulatory country requirements, reviewing/preparing local submission documents and performing submissions.
The type of individual I am looking for will need to be self-sufficient and very proactive in their approach to work.
- Informs the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level.
- Reviews/prepares local submission documents and performs submissions (Initial submissions, Substantial Amendments and Notifications etc.) to Ethics Committees Central and Local) and to Competent Authority for Clinical Trials/RWE in accordance with local country requirements (e.g. via portal upload or mail or Email); and delivers final submission package to RASSU Specialist assigned to the study.
- Identifies the Central and Local Ethics Committees and Competent Authority needed for the study on the country level; processes pre-payments to Ethics Committees and Competent Authority; adapts study-related documents (e.g. Informed Consent Forms) to meet each local country’s specifications in cooperation with the RASSU Specialist assigned to the study.
- Serves as applicant for Clinical trials/RWE and may act as main point-of-contact for the Ethics Committees and Competent Authority and the assigned RASSU Specialist to the study on the country level.
- Communicates closely with RASSU specialist assigned to the study regarding EC /CA outcomes.
- Assisting with site contract translation; tracking the progress by updating and maintaining internal systems, databases and tracking tools (including the Trial Interactive database) with project specific information.
- Identifies and establishes relationship with site personnel responsible for budget proposals.
- A minimum of 3-5 years of experience in Clinical Research
- Pharmaceutical, or CRO background and experience in regulatory in country.
- Associate’s or Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience (ideal, but not essential)
- Ability to collaborate well in a global team environment
- Ability to maintain confidentiality
- Strong computer skills and proficient with the use of Microsoft Word, Excel, and Powerpoint)
- Ability to provide a superior level of customer service
- Strong working knowledge of GCP, EU regulations and ICH guidelines, Drug Laws on country level
- Excellent verbal and written communication skills
- Fluent in spoken and written language in Italian and English