Clinical Study Start-up Specialist (DU/EN)

Oxford Global Resources; Diegem; Sur place; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Fulltime position

Hybrid working

Salary based on experience

Résumé du poste

Oxford Global Resources is seeking a Clinical Study Start-up Specialist for a medical device client in the Brussels area. The role covers Belgium and the Netherlands, requires fluent Dutch and English, and 5–6 years in clinical research with EC submissions.

Hybrid work 2–3 days in the office, with global stakeholders and cross-functional collaboration. The successful candidate will independently manage regulatory docs, study activation, and risk mitigation, contributing to on-time delivery of

Qualifications

• Fluent Dutch and English.
• 5–6 years in clinical research or related environments.
• Experience with Ethics Committee submissions.

Responsabilités

• Lead Ethics Committee submission and site activation activities in Belgium and the Netherlands.
• Manage submission strategies, timelines, risks and stakeholder expectations.
• Handle regulatory documentation ensuring quality, compliance and inspection readiness.
• Maintain study information in Veeva Vault, CTMS, eTMF and other systems.
• Partner with Clinical Operations, Site Management, Trial Management and other stakeholders.
• Identify risks early and drive mitigation strategies with limited supervision.
• Support audit and inspection readiness activities.
• Share knowledge and mentor team members as appropriate.
• Contribute to process improvements to enhance efficiency and compliance.

Connaissances

Dutch language

English language

Clinical research

Ethics Committee submissions

GCP knowledge

Independent work

Cross-functional collaboration

Regulatory submissions

Outils

Veeva Vault

CTMS

eTMF

Description du poste

Job Description

For one of our clients, a medical device company based in the North of Brussels, we are looking for an enthusiastic Clinical Study Start-up Specialist to come on board and join the team to cover sites located in Flanders and in the Netherlands. This position is open for candidates with fluency in Dutch and English and a few years experience in clinical research, specifically in EC submissions. This opportunity is hybrid working: 2-3 days/week office-based at the client's location.

We are looking for an experienced Clinical Research professional to play a key role in the execution of global clinical trials supporting innovative medical technologies. This position offers the opportunity to work independently, interact with international stakeholders, contribute to regulatory and site activation activities, and influence the successful delivery of clinical studies across Europe. The successful candidate will join an experienced international team and will be trusted to independently manage assigned countries and activities, make day-to-day operational decisions, identify risks early, and drive solutions in partnership with cross‑functional stakeholders.

Responsibilities

• Serve as the operational lead for assigned Ethics Committee submission and site activation activities in Belgium and the Netherlands.
• Proactively manage submission strategies, timelines, risks and stakeholder expectations to support successful study execution.
• Independently manage regulatory documentation, ensuring quality, compliance and inspection readiness.
• Maintain accurate study information within Veeva Vault, CTMS, eTMF and other clinical systems.
• Partner closely with Clinical Operations, Site Management, Trial Management, Contract & Budget and other cross‑functional stakeholders.
• Identify risks early, recommend mitigation strategies and drive resolution with limited supervision.
• Support audit and inspection readiness activities.
• Share knowledge and best practices with team members and contribute to onboarding or mentoring activities when appropriate.
• May contribute to process improvement initiatives that enhance efficiency, quality and compliance across Trial Operations.

Requirements

Must have

• Fluent Dutch and English.
• Approximately 5‑6 years of experience in clinical research, medical device, pharmaceutical, CRO or related clinical trial environments.
• Previous hands‑on experience with Ethics Committee submissions.
• Strong understanding of the clinical trial lifecycle and GCP requirements.
• Experience managing activities independently with limited supervision.
• Experience operating within global and cross‑functional clinical research environments.

Strongly preferred

• Experience supporting Belgium and/or Netherlands regulatory submissions.
• Experience with Veeva Vault.
• Experience using CTMS and eTMF systems.
• Medical device clinical trial experience.
• Familiarity with MDR and ISO 14155 requirements.

Desired Personal Profile

• Enjoys taking ownership and making a meaningful contribution to team success.
• Proactive mindset and strong sense of accountability.
• High quality standards and attention to detail.
• Strong prioritization and organizational skills.
• Ability to identify risks, solve problems and make sound operational decisions.
• Curiosity, learning agility and continuous improvement mindset.
• Confidence to ask meaningful questions and appropriately challenge assumptions.
• Excellent communication and stakeholder management skills.
• Strong collaborative mindset and commitment to collective success.

Benefits

• Fulltime position
• A balanced salary package based on your capabilities and experience, including extra legal benefits
• Hybrid working: 2‑3 days/week home‑based.