Study Site Management Specialist(m/w/x)

Beschreibung

In this home-based role, you will drive the site activation process by managing regulatory documents and timelines while serving as the central point of contact for investigative sites and project teams.

Anforderungen

• •German language fluency
• •Local submissions experience
• •Bachelor’s Degree in life sciences, related field, or equivalent
• •3 years’ clinical research, relevant experience, or equivalent
• •In-depth knowledge of clinical systems
• •Knowledge of procedures and corporate standards
• •Ability to apply GCP/ICH and regulatory guidelines
• •Knowledge of local regulations and SOPs
• •Understanding of regulated clinical trial environment
• •Knowledge of drug development process

Aufgaben

• •Execute country-level site activation activities
• •Follow local and international regulatory guidelines
• •Adhere to SOPs and project requirements
• •Perform ongoing site maintenance activities
• •Act as the primary contact for investigative sites
• •Coordinate with project management and internal departments
• •Ensure quality of deliverables and project timelines
• •Distribute completed documents to sites and teams
• •Prepare and review site regulatory documents
• •Maintain internal systems and tracking tools
• •Provide feedback on site performance metrics
• •Establish and agree on project planning timelines
• •Implement monitoring measures and contingency plans
• •Track progress of ethics and regulatory approvals
• •Manage Informed Consent Form and Investigator Pack release
• •Offer local expertise during project timeline planning
• •Conduct quality control on site-provided documentation
• •Communicate directly with sponsors on specific initiatives

Tools & Technologien