Clinical Study Start-up Specialist
Il y a 2 jours
Diegem, Belgique
Oxford Global Resources
Temps plein
Gratuit avec email ou Google
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Gratuit avec email ou Google
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. Vacancy number : 27413
- 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. Vacancy number : 27413