Overview

As Startup Specialist, you drive the start-up of clinical trials across multiple sites, ensuring regulatory compliance and quality. You work with cross-functional teams and the Regional Submission Lead to hit milestones and tailor study documents to country needs. You oversee document management, submissions, and amendments, while maintaining inspection readiness. You contribute to continuous improvement and IVDR-startup activities when required, enabling timely trial initiation.

Responsabilidades

- Plan and oversee site start-up activities to meet deadlines and quality standards
- Coordinate with Regional Submission Lead to achieve start-up milestones
- Provide country-specific start-up expertise and support budget/contract negotiations
- Review and translate informed consent forms and site documents for country requirements
- Manage essential document collection and site file reconciliation
- Perform quality reviews of submission packages and submit to EC/HA as needed
- Oversee protocol amendments and ensure regulatory compliance throughout the study lifecycle
- Ensure inspection readiness of start-up documentation
- Identify site issues,



propose corrective/preventive actions, and escalate as needed
- Coordinate IVDR-related startup activities and regulatory compliance when required
- Notify health authorities of study milestones and conclusion as mandated
- Serve as escalation point for SSUS-related site issues
- Act as SME for clinical operations, country regulations, and SSU activities
- Travel as required

Requisitos principales

- 2+ years in the pharmaceutical industry, preferably in a startup role
- Solid understanding of regulatory processes and compliance in clinical research
- Fluent in English, Spanish, and Portuguese (speaking and writing)
- Excellent communication and interpersonal skills
- Knowledge of ICH and related regulatory guidelines
- Experience in start-up activities in pharma or CRO industries
- Bachelors degree in Life Sciences, Pharmacy, Biomedicine, or related field

- strong communication
- collaboration
- problem-solving
- start-up processes for clinical trials
- regulatory submissions and approvals
- documentation management and site file reconciliation

📌 Study Start-up Specialist (Santa Cruz de Tenerife)
🏢 Beigene
📍 Santa Cruz de Tenerife