Site Start-up Specialist – FSP

This is a fully remote position, open to applicants in Sweden.

📋 Description

• Act as the main point of contact for investigative sites throughout start-up and maintenance phases.

• Gather, assess, and organize vital documents necessary for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).

• Ensure adherence to ICH/GCP guidelines, regulatory mandates, and sponsor requirements.

• Prepare and file regulatory documents, including country-specific application forms and informed consent forms.

• Monitor submission timelines and proactively tackle potential delays.

• Collaborate with both internal and external partners, such as vendors, clinical teams, and regulatory authorities.

• Guarantee that all documentation is audit-ready and that systems are regularly updated.

• Assist in negotiating site contracts and budgets, if necessary.

• Provide guidance and training to new hires and less experienced team members.

⛳️ Requirements

• University/College degree (preferably in life sciences) or certification in a related allied health profession.

• At least 2 years of experience in clinical research, regulatory submissions, or site activation.

• Strong understanding of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.

• Capability to review and modify patient informed consent forms to comply with local and protocol-specific standards.

• Experience in engaging with regulatory authorities and site start-up teams.

• Exceptional organizational, problem-solving, and communication abilities.

• Proficient in Microsoft Office and document management systems.

• Fluent in both the local language and English.

🏝️ Benefits

• Competitive salary along with performance-based incentives.

• Flexible work arrangements (remote/hybrid options available).

• Opportunities for professional development in a collaborative and innovative setting.

• The chance to engage in groundbreaking clinical research projects.