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:
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Ensuring business continuity for key clinical digital solutions
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Supporting day-to-day operations and incident management
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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
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Manage day-to-day operational activities for digital clinical systems in “run mode”
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Handle and prioritize change requests, incident/issue resolution, and unplanned activities
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Monitor system performance and ensure reliability, availability, and continuity of service
Validation & Compliance
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Support and execute GxP validation activities (IQ, OQ, PQ, testing, documentation)
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Ensure compliance with GxP, GCP, 21 CFR Part 11 and internal quality standards
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Contribute to validation strategies, test plans, and related documentation for clinical systems
Stakeholder Management & Coordination
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Coordinate activities across multiple stakeholders (IT, Clinical Operations, Quality, vendors)
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Act as a technical and operational reference point for assigned digital clinical solutions
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Lead transversal activities involving up to ~20 stakeholders, ensuring alignment and timely delivery
Veeva & Clinical Systems Support
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Provide hands-on support for Veeva Vault–based platforms and related clinical systems
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Contribute to configuration, enhancement, and troubleshooting of Veeva Vault solutions
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Support integration and interactions with other clinical systems (e.g., CTMS, eTMF, eCOA, EDC where applicable)
Profile Requirements
Experience
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Minimum 8 years of relevant experience in a pharmaceutical or life sciences environment
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Proven experience in computerised system validation in regulated environments (GxP)
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Senior, autonomous profile able to be productive with minimal ramp-up
Must-Have Skills
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Solid experience in the pharmaceutical industry or similarly regulated life sciences context
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Strong knowledge of computerised system validation (GxP, GCP, 21 CFR Part 11)
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Hands-on experience with Veeva Vault (configuration, support, and/or implementation)
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Demonstrated ability to manage an operational workload in a fast-moving run environment
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Strong coordination, communication, and stakeholder management skills
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Technical background (e.g., IT, engineering, informatics) combined with a delivery/execution mindset
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Not a pure project management role; requires hands-on involvement
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Ideal Candidate
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Senior, hands-on digital clinical professional with a strong validation mindset
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Able to work autonomously in a complex, global, and matrixed environment
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Combines technical expertise, operational execution, and clear communication
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Comfortable leading transversal activities and coordinating up to 20 stakeholders
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Prior exposure to Clinical Operations and clinical trial processes is a strong differentiator
Nice-to-Have
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Previous experience within large global pharma/biotech organizations
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Exposure to clinical systems such as CTMS, eTMF, eCOA, EDC
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Agile or Project Management certifications (e.g., Scrum, PMP, Prince2)
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Experience with data or document migrations in a regulated context
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Veeva certifications (beneficial but not mandatory)
Soft Skills
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Strong problem-solving and analytical skills
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High level of ownership and accountability
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Ability to work under pressure and manage multiple priorities
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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.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!