SSU and Regulatory Specialist in Kyiv Ukraine Here in Syneos Health we are looking for Site Start up and Regulatory Specialist.
SSURS performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials.
Responsible for delivery, with moderate oversight from the SSU Country Manager and specialist knowledge in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and reviews of essential documents required for site initiation.
Ensures 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 and some level of supervision 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.
At a project level, may act as SSUL for local studies. May provide support as the Country Start-Up Advisor (CSA).
Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
Ability to understand clinical protocols and associated study specifications.
Detailed understanding of clinical trial start-up processes.
Ability to manage external vendors to contract effectively.
Strong organizational skills with ability to handle multiple tasks effectively.
Strong written and verbal communication and interpersonal skills.
Ability to manage multiple project budgets with increased complexity and value.
Quality-driven in all managed activities.
Good negotiating skills.
Good problem-solving skills.
Demonstrated ability to work independently as well as part of a team.
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.
#LI-PL1 Kyiv Ukraine
SSU and Regulatory Specialist in Kyiv Ukraine Syneos Health Kyiv