Clinical Trial Site Start-Up Lead

Fortrea; Madrid; Presencial; EUR 42.000 - 64.000; Jornada completa

Descripción de la vacante

Fortrea is seeking a Site Start-Up Specialist in Madrid, Spain, to coordinate site activation, manage essential regulatory documents, and ensure timely submissions in line with ICH/GCP guidelines. You will work within the FSPx team, collaborating with sponsors and clinical teams to advance trials.

The role requires a life sciences-related degree or allied health certification, 2+ years in clinical research or start-up activities, and strong organizational and communication skills.

Formación

• University degree or allied health certification; life sciences preferred.
• Minimum 2 years in clinical research, regulatory submissions, or site activation.
• Strong knowledge of ICH/GCP, RA, IRB/IEC regulations, and start-up processes.
• Ability to adapt patient informed consent forms to local and protocol-specific requirements.
• Experience interacting with regulatory authorities and site start-up teams.
• Excellent organizational, problem-solving, and communication skills.
• Proficiency in Microsoft Office and document management systems.

Responsabilidades

• Serve as the primary contact for investigative sites during start-up and maintenance activities.
• Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).
• Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.
• Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.
• Track submission timelines and proactively address potential delays.
• Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.
• Ensure all documentation is audit-ready and systems are consistently updated.
• Assist in the negotiation of site contracts and budgets, if applicable.
• Provide mentorship and training to new hires and less-experienced colleagues.

Conocimientos

Excellent organizational skills

Problem-solving skills

Communication skills

Educación

University/College degree (life sciences preferred) or allied health certification

Herramientas

Microsoft Office

Document management systems

Descripción del empleo

Fortrea is seeking a Site Start-Up Specialist in Madrid, Spain, to coordinate site activation, manage essential regulatory documents, and ensure timely submissions in line with ICH/GCP guidelines. You will work within the FSPx team, collaborating with sponsors and clinical teams to advance trials.

The role requires a life sciences-related degree or allied health certification, 2+ years in clinical research or start-up activities, and strong organizational and communication skills.