Job description
Context
The role supports the digital technology portfolio for clinical trials, with a strong focus on operational “run” activities rather than large transformation programs.
Due to significant growth in digital clinical solutions and limited capacity in the current team, this is a newly created position aimed at:
* Ensuring business continuity for key clinical digital solutions
* Supporting day-to-day operations and incident management
* Acting as a delegate for existing internal team members
The role will work closely with IT, Clinical Operations, Quality and external vendors (notably Veeva).
Main Responsibilities
Operational & Run Activities
* Manage day-to-day operational activities for digital clinical systems in “run mode”
* Handle and prioritize change requests, incident/issue resolution, and unplanned activities
* Monitor system performance and ensure reliability, availability, and continuity of service
Validation & Compliance
* Support and execute GxP validation activities (IQ, OQ, PQ, testing, documentation)
* Ensure compliance with GxP, GCP, 21 CFR Part 11 and internal quality standards
* Contribute to validation strategies, test plans, and related documentation for clinical systems
Stakeholder Management & Coordination
* Coordinate activities across multiple stakeholders (IT, Clinical Operations, Quality, vendors)
* Act as a technical and operational reference point for assigned digital clinical solutions
* Lead transversal activities involving up to ~20 stakeholders, ensuring alignment and timely delivery
Veeva & Clinical Systems Support
* Provide hands-on support for Veeva Vault–based platforms and related clinical systems
* Contribute to configuration, enhancement, and troubleshooting of Veeva Vault solutions
* Support integration and interactions with other clinical systems (e.g., CTMS, eTMF, eCOA, EDC where applicable)
Profile Requirements
Experience
* Minimum 8 years of relevant experience in a pharmaceutical or life sciences environment
* Proven experience in computerised system validation in regulated environments (GxP)
* Senior, autonomous profile able to be productive with minimal ramp-up
Must-Have Skills
* Solid experience in the pharmaceutical industry or similarly regulated life sciences context
* Strong knowledge of computerised system validation (GxP, GCP, 21 CFR Part 11)
* Hands-on experience with Veeva Vault (configuration, support, and/or implementation)
* Demonstrated ability to manage an operational workload in a fast-moving run environment
* Strong coordination, communication, and stakeholder management skills
* Technical background (e.g., IT, engineering, informatics) combined with a delivery/execution mindset
o Not a pure project management role; requires hands-on involvement
Ideal Candidate
* Senior, hands-on digital clinical professional with a strong validation mindset
* Able to work autonomously in a complex, global, and matrixed environment
* Combines technical expertise, operational execution, and clear communication
* Comfortable leading transversal activities and coordinating up to 20 stakeholders
* Prior exposure to Clinical Operations and clinical trial processes is a strong differentiator
Nice-to-Have
* Previous experience within large global pharma/biotech organizations
* Exposure to clinical systems such as CTMS, eTMF, eCOA, EDC
* Agile or Project Management certifications (e.g., Scrum, PMP, Prince2)
* Experience with data or document migrations in a regulated context
* Veeva certifications (beneficial but not mandatory)
Soft Skills
* Strong problem-solving and analytical skills
* High level of ownership and accountability
* Ability to work under pressure and manage multiple priorities
* Excellent written and verbal communication skills in English; additional languages are a plus
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.