Study Start-Up & Regulatory Specialist - Benelux
- Experience Level
- Experienced (non-manager)
Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for providing delivery and expertise 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. 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. At a project and local level, may act as Site Start-up Lead (SSUL). May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs). Under the direction of the Project Manager (PM) or SSUL as appropriate, may directly interact with Customers when receive requirements from RA or other local regulatory party. Accountable to the PM/SSUL at the project level and line manager for deliverables. At a project level, may act as SSUL for local studies. May act as the Country Start-Up Advisor (CSA)
BA/BS degree in the science/health care field, legal degree, or equivalent combination of education and experience. Moderate clinical research or related experience. Knowledge of and understanding of the overall drug development process. Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations and European Union Directive. Demonstrated clinical development and clinical research knowledge. Excellent verbal, interpersonal, and written communication skills in both local and English language. Good record retention and customer service skills. Proficient in the use of computer and software systems (e.g., Excel). Ability to successfully support internal and external customers. Ability to develop, organize, and manage multiple tasks. Ability to work independently.