Solutions Expert – Clinical Data Acquisition

MSI Pharma; Belgique; Sur place; USD 96 000 - 175 000; Plein temps

Avantages offerts par ce poste

Competitive hourly rate

Résumé du poste

A biopharma organization is seeking an IT Solution Expert to support and enhance Clinical Data Acquisition platforms, specifically Medidata and TrialGrid. The role involves acting as the technical owner for system updates, incident management, and ensuring compliance with IT change management processes. Candidates should hold a Bachelor's degree in Computer Science, have direct experience with Medidata platforms, and possess strong skills in computerized systems validation. Fluent English and excellent team collaboration abilities are essential.

Qualifications

• Direct experience with Medidata platforms (e.g., iMedidata, Cloud Admin, Rave, Coder).
• Proven experience in computerized systems validation (CSV).
• Experience in computerized system testing.
• Strong IT change management background.
• Experience with access management.

Responsabilités

• Provide ongoing support and maintenance for the organization’s Clinical Data Acquisition platform.
• Support and maintain the TrialGrid system used to validate clinical study builds.
• Drive IT changes, including updates to computerized system validation documentation.
• Lead IT changes, including IQ/OQ testing and validation documentation.
• Handle access management for designated user roles.
• Collaborate with SMEs to resolve incidents per ITIL.
• Support periodic reviews of systems.

Connaissances

Medidata platforms

Computerized system validation

IT change management

Access management

Technical documentation

Team collaboration

Fluent English

Formation

Bachelor's degree in Computer Science or related field

Outils

TrialGrid

Medidata iMedidata

Rave

Cloud Admin

Coder

Description du poste

IT Solution Expert - Clinical Data Acquisition Systems | Location: Brussels Region, Belgium (Hybrid) | Engagement: Freelance | Client: Biopharma | Competitive hourly rate available

We are supporting a major biopharma organisation in hiring an IT Solution Expert to provide end‑to‑end support, maintenance, and enhancement of their primary clinical data acquisition platforms, including a suite of Medidata solutions and Trial Grid. You will act as the technical owner for system updates, validation activities, incident management, and change control while collaborating with internal teams and external platform providers. This is a high‑impact role supporting global clinical development operations.

Key Responsibilities

• Provide ongoing support and maintenance for the organization’s Clinical Data Acquisition platform (incl. Medidata iMedidata, Rave, Coder, Cloud Admin and Coder+).
• Support and maintain the TrialGrid system used to validate clinical study builds.
• Assess the impact of new Medidata and TrialGrid product releases on availability, security, interfaces, and maintenance requirements.
• Drive IT changes, including updates to computerized system validation documentation, IQ/OQ testing, and implementation of new/changed user requirements.
• Perform access management for designated user roles.
• Collaborate with SMEs to resolve incidents in alignment with ITIL best practice.
• Support the periodic review of Clinical Data Acquisition and TrialGrid systems.

Requirements

Education

• Bachelor’s degree (minimum) in Computer Science or a related field.

Experience & Technical Skills

Mandatory

• Direct experience with Medidata platforms (e.g., iMedidata, Cloud Admin, Rave, Coder).
• Proven experience in computerized systems validation (CSV).
• Experience in computerized system testing.
• Strong background in IT change management.
• Experience handling access management.

Preferred

• Experience with TrialGrid.
• ITIL‑aligned incident management experience.
• Background in the pharmaceutical industry (3+ years preferred).
• Knowledge of Clinical Development processes.

Soft Skills

• Fluent in English (written and spoken).
• Strong technical documentation writing skills.

Excellent team collaboration abilities.