Senior Site Activation Specialist

Location: Madrid or Barcelona, Spain
Work Model: Hybrid

Job Description Summary

We are seeking a Senior Site Activation Specialist to support country-level Site Activation (SA) activities. This role is responsible for ensuring site start-up and activation processes are executed in compliance with applicable local and international regulations, Standard Operating Procedures (SOPs), project requirements, and contractual or budgetary guidelines.

This is a developing professional individual contributor role, working under moderate supervision. The Senior Site Activation Specialist is expected to proactively identify opportunities to improve systems and processes, helping to enhance efficiency and effectiveness across the site activation function.

Job Overview

The Senior Site Activation Specialist performs a wide range of site activation and maintenance activities at a country level. The problems encountered are generally well-defined and may require understanding of broader operational issues, though they are not highly complex. The role includes close collaboration with cross-functional teams and, on occasion, direct interaction with sponsors.

Essential Functions

• Serve as the Single Point of Contact (SPOC) for assigned studies, acting as a liaison between investigative sites, the Site Activation Manager (SAM), Project Management teams, and other internal departments, under general supervision.
• Ensure adherence to SOPs, Work Instructions (WIs), quality standards, and project timelines for all assigned deliverables.
• Perform feasibility, site identification, start-up, and site activation activities in accordance with applicable regulations, SOPs, and WIs.
• Prepare site-related documentation and review all documents for completeness, accuracy, and quality.
• Distribute completed documents to investigative sites and internal project team members.
• Maintain accurate and up-to-date information in internal systems, databases, and tracking tools.
• Review site performance metrics and provide feedback and insights to management.
• Review, establish, and agree on project plans and timelines, ensuring appropriate monitoring measures are in place and implementing contingency plans when required.
• Communicate completion status of feasibility, site identification, regulatory, and contractual documents to relevant team members.
• Track, follow up, and support the approval and execution of key documents, including:
  • Questionnaires
  • CDA/SIF
  • Regulatory and ethics submissions
  • Informed Consent Forms (ICFs)
  • Investigator Pack (IP) release documentation
• Provide local regulatory and operational expertise to SAMs and project teams during both initial planning and ongoing project execution.
• Perform quality control checks on documentation provided by investigative sites.
• Participate in direct sponsor interactions on specific initiatives, as required.

Qualifications

Education

• Bachelor’s Degree in Life Sciences or a related field (required)
• Spanish Native & English proficiency

Experience

• Minimum of 3 years of clinical research or relevant industry experience, or an equivalent combination of education, training, and experience (required)
• At least 3 years of clinical research experience, including 1 year in a leadership or coordination capacity (required)