Clinical Associate Regulatory Submissions(m/w/x)

Beschreibung

In this role, you will engage in Site Activation activities while ensuring compliance with regulations. Your day-to-day responsibilities will include preparing regulatory submissions, coordinating with teams, and mentoring junior associates, all while maintaining project timelines.

Anforderungen

• •EU CTR experience for Germany and Austria
• •Local language proficiency
• •Knowledge of national requirements
• •B Sc degree in Health Sciences or related field
• •1 - 3 years' relevant clinical research experience
• •Experience in EUCTR and CTIS submission procedures
• •Feasibility and Country Inform Consent adaptation for DACH regions
• •Experience in Site Contract negotiations with DACH sites
• •Experience in medical device submissions is beneficial
• •In-depth knowledge of clinical systems, procedures, and corporate standards
• •Good negotiating and communication skills in local language
• •Effective communication, organizational, and interpersonal skills
• •Ability to work independently and to effectively prioritize tasks
• •Ability to manage multiple projects
• •Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• •Understanding of regulated clinical trial environment and knowledge of drug development process

Aufgaben

• •Perform Site Activation activities in compliance with local and international regulations
• •Serve as the Single Point of Contact for assigned studies
• •Ensure adherence to standard operating procedures and project timelines
• •Prepare and submit regulatory documents to relevant authorities
• •Conduct feasibility, site identification, and start-up activities
• •Distribute completed documents to sites and internal teams
• •Review site documents for completeness and accuracy
• •Track and follow up on the approval and execution of various documents
• •Inform team members of the completion of regulatory and contractual documents
• •Provide local expertise during project timeline planning
• •Perform quality control on documents submitted by sites
• •Mentor junior Clinical Associates and act as a subject matter expert