Clinical Systems Specialist - eTMF (Veeva) - LATAM

Alimentiv; Buenos Aires; Presencial; ARS 6.500.000 - 9.750.000; Jornada completa

Descripción de la vacante

A leading company in the clinical trials industry is seeking a Clinical Systems Specialist to ensure the optimal functioning of trial systems, manage user support, and uphold compliance standards. This role requires collaboration with various teams to enhance system efficiencies and conduct training for end-users. Candidates should have a bachelor's degree and relevant experience in system management and user support.

Formación

• 4 - 6 years of related experience required.
• Education in IT or related field preferred but not required.
• Experience with system configuration, validation, and troubleshooting.

Responsabilidades

• Support system development lifecycle including requirements analysis and configuration.
• Provide user technical support and training.
• Assist with compliance and audit activities.

Conocimientos

Problem-solving

Analytical skills

Communication skills

Attention to detail

Educación

Bachelor’s degree

Herramientas

Clinical trial platforms (CTMS, EDC, eTMF)

Descripción del empleo

The Clinical Systems Specialist plays a critical role in the implementation, management, and optimization of clinical trial systems, ensuring their functionality and alignment with study needs. They collaborate with the System Administrator and vendor on system configuration to deliver features, fixes, and updates in alignment with the system’s roadmap, ensuring efficient operation and compliance throughout the clinical trial lifecycle. Additionally, they assist with system maintenance activities and act as the primary point of contact for training, end-user technical support, and communications to ensure operational efficiency and compliance with internal and external requirements.

System Development & Implementation (10-20%)

• Support the System Administrator in performing key system development lifecycle (SDLC) activities including requirements analysis, configuration, validation, system updates, and change control.
• Collaborate with IT and clinical teams to improve system efficiencies and automation, supporting continuous improvement of system management.

System Maintenance, Security & Compliance (30-40%)

• Support user account management and access controls for compliance with regulatory standards and assist with user access reviews.
• Support audit activities (sponsor audits, vendor audits, and regulatory audits) to demonstrate compliance.
• Coordinate and execute data governance initiatives such as data cleaning, training end-users or other support staff on data governance, and oversee these activities.
• Assist with system-related assessments including vendor assessments, risk assessments, validation reviews, and audit trail reviews.
• Support data inputs, lead data governance efforts, and generate reports or dashboards for end-users.

User Support & Training (40-50%)

• Provide technical support and troubleshooting for end-users.
• Provide training and collaborate on creating training materials.
• Support study-related services including setup and reporting to aid study reporting and compliance activities.
• Oversee user onboarding, including role assignments and study access.

Qualifications

• 4 - 6 years of related experience.
• Bachelor’s degree (Honors preferred).

Additional Knowledge / Skills

• Education in IT, software, or related field preferred but not required.
• Strong problem-solving, analytical, and communication skills.
• Ability to work independently and in teams.
• Experience with clinical trial platforms such as CTMS, EDC, eTMF, or similar systems.
• Experience with system configuration, validation, troubleshooting in regulated environments.
• Understanding of clinical trial processes, regulatory standards like GxP, 21 CFR Part 11.
• Knowledge of validation procedures, UAT, compliance documentation.
• Familiarity with clinical data standards and audit processes.
• Attention to detail, ability to manage multiple projects, meet deadlines, and work independently.

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