Regulatory and Start Up Specialist 1 (m/w/d) Home Based Germany

Location: Home based in Germany; Frankfurt, Hesse, Germany

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Manage site identification and regulatory start-up, maintenance, and site activation activities.
• Prepare, review, distribute, and maintain site regulatory documentation, ethics documents, informed consent forms, and investigator package materials.
• Review and negotiate regulatory documents and contracts with investigative sites and sponsors, and track their approval and execution.
• Act as the primary point of contact for investigative sites, Site Activation Managers, project management, and other departments.
• Establish project timelines, monitor site performance metrics, and implement contingency plans when needed.
• Maintain project information in internal systems and perform document quality control in accordance with applicable procedures.

Requirements

• High school diploma or equivalent.
• Previous experience in regulatory and start-up activities.
• Knowledge of applicable regulations and compliance requirements.
• Fluent German language skills required.
• Ability to follow regulations, standard operating procedures, work instructions, project requirements, and timelines.

Culture & Benefits

• Home-based work arrangement in Germany.
• Work on clinical research projects supporting the development and commercialization of medical treatments.
• Collaboration with global clinical research teams and investigative sites.