Senior Site Activation Specialist
Job Summary
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
- Bachelors 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)
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at .
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.
At IQVIA we believe that diversity inclusion and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone everywhere. When our talented employees bring their authentic selves and their diverse experiences to work they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise as part of this culture IQVIA is committed to ensuring effective equality between women and men integrating it as a strategic principle in its corporate and human resources policies.
Required Experience:
Senior IC
Key Skills
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more