SSU & Regulatory Specialist - Italy
- Experience Level
- Experienced (non-manager)
Here at Syneos Health we are currently recruiting for an Italian Study Start Up & Regulatory Specialist to sit within our Country SSU department. The function of this role is to perform assigned activities within that lead to start-up of investigative sites in various phases of clinical trials in Italy. Effective and efficient execution of this plays a key part in our goal of shortening the distance from lab to life.
This is an Italy based role and can be home based or office based.
A short summary of the role is as follows:
- You will be responsible for the delivery of assigned duties to enable study start up, with moderate oversight from the SSU Country Manager. You will have specialist knowledge in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and review of essential documents required for site initiation. You will ensure local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards, and you will ensure an efficient start-up process on assigned studies.
- In this role you may act as main point of contact with Regulatory Authorities and Central/Regional Ethics Committees. Under the direction and some level of supervision of the Project Lead or SSU Lead as appropriate, you may directly interact with Customers when receiving requirements from the Regulatory Authority or other local regulatory party.
- You will be accountable to the Project Lead or SSU Lead at the project level, and to your line manager for deliverables. At a project level, you may act as SSU Lead for local studies. You may provide support as the Country Start-Up Advisor.
This is a role in which strong communication and organisational skills are key to success, alongside the ability to work independently and organise and prioritise workload in order to meet deadlines in a dynamic environment.
Qualifications - External
- Minimum of 2 years experience in a similar role in the industry - UK competent authority and ethics submissions experience is essential
- Degree educated or equivalent combination of education and relevant experience.
- Detailed understanding of the clinical trial process across Phases II-IV and ICH GCP
- Ability to understand clinical protocols and associated study specifications.
- Ability to manage multiple project budgets with increased complexity and value
- Ability to external vendors to contract effectively.
- Demonstrated ability to work well independently as well as part of a team.
- Ability to manage time to organize and prioritize work and meet deadlines in a dynamic environment.
If you have the necessary experience and are eligible to work in the required location, please submit an application.
What happens next?
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
Why Syneos Health?
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. The Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Learn more about how we are shortening the distance from lab to life® at syneoshealth.com.
Disclaimer: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.