Global Study Associate - Sponsor Dedicated

IQVIA; Alicante; Presencial; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

A leading company in clinical research is seeking a Global Study Associate to support clinical studies throughout their lifecycle. The role involves assisting study teams with documentation, compliance tracking, and administrative tasks. Ideal candidates will have a background in clinical practice or life sciences, with strong organizational and communication skills. This position offers an opportunity to work in a dynamic environment focused on improving study outcomes.

Formación

• 3-5 years of experience as a clinical trial manager.
• 1-3 years supporting global study teams in clinical research.
• Basic understanding of Essential Documents, CFR, and ICH GCP guidelines.

Responsabilidades

• Assist global study teams with delegated activities.
• Lead setup and maintenance of systems tracking study compliance.
• Support administrative activities and documentation management.

Conocimientos

Organizational skills

Communication skills

Time management

Team-oriented attitude

Proactive initiative-taking

Relationship-building skills

Educación

Associate's degree in clinical practice, healthcare, life sciences

Herramientas

Microsoft Office

eTMF

Veeva Systems

Descripción del empleo

The Global Study Associate (GSA) is a role within Development Operations that supports the delivery of clinical studies across the entire study lifecycle, including start-up, conduct, close-out, and archival. The GSA assists in delegated activities related to timelines, costs, and quality, with a focus on maintaining inspection readiness.

The GSA operates in accordance with the Rare Disease Study Team Operating Model for Internal Delivery (rSOLID), applicable controlled procedures, guidance materials, job aids, current clinical trial regulations (e.g., ICH GCP), and policies aligned with the sponsor's mission, values, and behaviors. Studies may span various therapeutic areas and phases (I-IV, including Late Phase, Non-Interventional, Post-Authorization Safety Studies, Registries, Early Access Programs, etc.).

Responsibilities:

• Assist global study teams (GSAMs, GSMs, GSADs, GSDs) in completing delegated study and functional activities, including drafting and maintaining the study team roster and supporting training requirements.
• Collaborate on the preparation, handling, distribution, maintenance, and archiving of study-related documentation and reports.
• Lead setup, maintenance, and close-out of systems tracking study and site compliance and performance (e.g., Veeva Systems, SharePoint, Smartsheet).
• Conduct periodic reviews of study files for completeness per the TMF Plan.
• Coordinate with study teams on Clinical Trial Supplies management and tracking.
• Serve as a central contact point for project communications and documentation.
• Support administrative activities such as preparing agendas, minutes, action item tracking, and generating reports and metrics.
• Assist with vendor oversight, contract management, and site quality audits or inspections.
• Participate in process improvements and other non-drug project activities as discussed with management.
• Support additional study and functional activities as needed.

Requirements:

• Associate's degree or equivalent in clinical practice, healthcare, life sciences, or related fields, or relevant work experience.
• 3-5 years of experience as a clinical trial manager.
• 1-3 years supporting global study teams in a clinical research environment.
• Strong organizational, communication, and time management skills.
• Team-oriented attitude and collaborative mindset.
• Proficiency with systems such as Microsoft Office (Excel, PowerPoint, SharePoint), eTMF, and Veeva Systems.
• Ability to work efficiently in a fast-paced environment and adapt to change.
• Experience with time-sensitive projects and proactive initiative-taking.
• Excellent relationship-building skills.
• Ability to work in an office setting, engaging in communication via phone, video, and electronic messaging, with general availability during standard business hours.
• Basic understanding of Essential Documents, CFR, and ICH GCP guidelines.
• Knowledge of project management principles and methodologies.