Sr SSU & Regulatory Specialist - Bulgaria
- Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials.
- Is responsible for providing delivery and expertise, with minimal oversight from the SSU Country Manager in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation.
- Accountable local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards.
- Ensures an efficient start-up process on assigned studies.
- May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs).
- Under the direction of the Project Lead (PL) or SSUL as appropriate, may directly interact with Customers when receive requirements from RA or other local regulatory party.
- Accountable to the PL/SSUL at the project level and line manager for deliverables.
- May act as the Country Start-Up Advisor (CSA) or as a line manager / mentor for less experienced staff. At a project level, may act as SSUL for local or regional studies.
- Bachelor’s Degree
- Fluent Bulgarian as well as fluent English
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
- Good vendor management skills
- Strong organizational skills with proven ability to handle multiple projects
- Excellent communication, presentation and interpersonal skills
- Ability to mentor, lead and motivate more junior staff
- Demonstrate an ability to provide quality feedback and guidance to peers
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.