Beschreibung

In this role, you will lead complex projects and ensure compliance with regulations while managing site activation activities. Your day-to-day responsibilities will include preparing submission documents, conducting feasibility studies, and mentoring junior team members.

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 country-level tasks for Site Activation activities
• •Ensure compliance with local and international regulations
• •Adhere to standard operating procedures (SOPs) and project requirements
• •Prepare and submit documents to regulatory bodies
• •Conduct feasibility and site identification activities
• •Manage site activation activities according to regulations and SOPs
• •Distribute completed documents to sites and project team members
• •Review site documents for completeness and accuracy
• •Track and follow up on document approvals and executions
• •Inform team members of document completion for individual sites
• •Provide local expertise to Site Activation Managers and project teams
• •Perform quality control on documents from sites
• •Act as a subject matter expert on specific topics
• •Mentor junior Clinical Associates