Site Start-Up Specialist (Clinical Research, Remote, Europe)

Job summary

This role involves coordinating site start-up activities for clinical trials, ensuring regulatory compliance, and managing essential documentation to facilitate the efficient submission of regulatory documents. The position requires proficiency in German and is open to candidates based in various European countries.

Qualifications

• University or college degree in life sciences or a related field, or equivalent experience.
• At least 2 years of experience in clinical research, regulatory submissions, or site activation.
• Strong understanding of ICH/GCP guidelines and regulatory requirements.
• Experience with patient informed consent forms and interactions with regulatory authorities.
• Excellent organizational, problem-solving, and communication skills.
• Proficient in Microsoft Office and document management systems.

Responsibilities

What We Offer

• Act as the primary contact for investigative sites during start-up and maintenance phases.
• Collect, review, and organize documents for regulatory submissions.
• Ensure compliance with relevant guidelines and sponsor specifications.
• Prepare and submit regulatory documents, including application forms and consent forms.
• Monitor submission timelines and address potential delays proactively.
• Collaborate with stakeholders, including vendors and clinical teams.
• Maintain audit-ready documentation and update systems consistently.
• Assist in negotiating site contracts and budgets as needed.
• Mentor and train new hires and less-experienced colleagues.
• Competitive salary with performance-based incentives.
• Flexible work arrangements, including remote and hybrid options.
• Opportunities for professional growth in a collaborative environment.
• Involvement in innovative clinical research projects.