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Regulatory Affairs Manager

posted by: spj_bot

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

Support the enhancement of regulatory compliance and inspection readiness for clinical activities in Greece, with a focus on GCP and GDPR requirements. The role will provide local regulatory expertise and operational guidance to support teams ahead of a potential inspection by Greek health authorities.

Main Responsibilities:

  • Provide expert guidance on Greek regulatory requirements for clinical trials and local health authority expectations.
  • Advise internal teams on regulatory strategy and compliance matters.
  • Share insights and lessons learned from clinical trial submissions to Greek authorities.
  • Collaborate with local and global stakeholders on regulatory and operational topics.
  • Assess regulatory and quality risks and support inspection readiness activities.
  • Anticipate potential inspection findings and prepare responses to authority inquiries.
  • Review clinical trial conduct, investigator site practices, and monitoring activities.
  • Support deviation management, root cause analysis, and the development and implementation of CAPAs.

Requirements

Job Skills

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Senior Global Project Manager

posted by: spj_bot

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.

As a Study Team Leader (STL), you will be responsible for leading global clinical study teams and ensuring the successful execution of international Phase I–III clinical trials from study synopsis to study archiving. You will oversee timelines, budget, quality, CROs, vendors, and cross-functional teams while ensuring compliance with regulatory requirements and GCP standards.

Key Responsibilities

Job Skills

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Clinical Scientist Immunology

posted by: spj_bot

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.

As a Clinical Scientist, you will support the Study Medical Manager in the planning, execution, analysis, and reporting of clinical studies from study start-up through study close-out. You will contribute to protocol development, medical data review, study documentation, and cross-functional collaboration to ensure high-quality clinical trial delivery in compliance with regulatory requirements.

Key Responsibilities

Job Skills

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Infirmier(e) de recherche clinique

posted by: spj_bot

Rejoignez Excelya, une entreprise portée par les valeurs d’Audace, de Bienveillance et d’Énergie, où l’innovation et la collaboration sont au cœur de tout ce que nous faisons.

En tant que Infirmière de recherche clinique, vous jouerez un rôle central dans la conduite et le suivi des essais cliniques, en assurant la qualité et la fiabilité des données recueillies auprès des patients. Vous contribuerez à la mise en œuvre des protocoles d’étude, au suivi clinique et à la coordination des activités, dans le respect des exigences réglementaires et des bonnes pratiques cliniques, au sein d’un environnement de recherche translationnelle.

Vos missions principales :

Vous participerez au bon déroulement des études cliniques en assurant notamment :

Job Skills

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Business Development Manager - Banks & Wallets

posted by: spj_bot

GoMining is building the next generation of the Bitcoin economy.

Our mission is to transform Bitcoin from a passive asset into an everyday financial tool used by millions of people worldwide.

GoBTC Pay is expanding its payment ecosystem by integrating with banks, digital wallets, fintech platforms, and crypto infrastructure providers. We're looking for a commercially driven Business Development Manager to establish strategic relationships, close enterprise partnerships, and help scale Bitcoin payments globally.

About the Role

As a Business Development Manager – Banks & Wallets, you will drive the expansion of the GoBTC Pay ecosystem by securing commercial partnerships with financial institutions and digital payment platforms.

This is an enterprise business development role focused on identifying opportunities, leading commercial negotiations, managing complex sales cycles, and bringing partners from the first conversation through technical integration and launch.

You'll work closely with Product, Engineering, Legal, and Marketing teams to ensure every partnership delivers long-term business value.

Job Skills

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Communication Manager BELUX

posted by: spj_bot

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

Main Responsibilities:

Job Skills

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Clinical Study Leader

posted by: spj_bot

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

The Clinical Study Leader (CSL) oversees the operational execution of Phase 1/2 clinical trials across multiple countries, ensuring delivery on time, within budget, and to quality standards. Acting as the main operational contact, the CSL works closely with CROs, vendors, and reports to the Project Director.

Main Responsibilities:

  • Lead and coordinate the cross-functional clinical study team
  • Ensure on-time delivery of key study milestones
  • Monitor study progress, identify risks, and drive mitigation actions
  • Ensure compliance with protocol, ICH-GCP, and regulatory requirements
  • Act as main sponsor contact and oversee CRO performance
  • Manage external vendors, including deliverables and issue resolution
  • Contribute to study planning and development of key documents
  • Ensure study start readiness (sites, systems, supplies) and track budget/resources
  • Maintain clear communication, escalate issues, and ensure quality and inspection readiness

Requirements

Job Skills

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Clinical Study Assistant

posted by: spj_bot

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

The Clinical Trial Assistant (CTA) supports the planning and execution of Phase 1/2 clinical trials across multiple countries by providing operational, administrative, and logistical assistance. Working closely with the Project Director and clinical study leaders, the CTA helps ensure smooth study coordination, high-quality documentation, and effective communication with CROs and external vendors in a fast-paced biotech setting, and reports directly to the Project Director.

Main Responsibilities:

  • Supports daily clinical trial execution and logistics
  • Organizes team meetings and cross-functional coordination
  • Maintains Trial Master File (TMF) quality and completeness
  • Manages essential study and regulatory documents
  • Supports study start-up and vendor/CRO coordination
  • Assists with contracts, work orders, and purchase orders
  • Ensures effective communication and tracks key updates/decisions

Requirements

Job Skills

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Clinical Solution Architect eTMF

posted by: spj_bot

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.

The eTMF Specialist plays a key role within the Clinical Development Platform by ensuring the quality, compliance, and inspection readiness of the electronic Trial Master File (eTMF) across global clinical trials.

This role requires strong expertise in clinical documentation management, close collaboration with cross‑functional teams, and active involvement in audits and inspections within a regulated environment.

Key responsibilities :

Job Skills

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Clinical Trial Assistant

posted by: spj_bot

Excelya is looking for a motivated Clinical Trial Assistant to join our dedicated Clinical Operations team. As part of our company values of Audacity, Care, and Energy, you will contribute to advancing innovative clinical trials that improve patient outcomes.

In this role, you will oversee all aspects of clinical trials from site initiation to close-out, ensuring compliance with protocols and regulations while building strong relationships with study investigators and site staff.

Key Responsibilities

Job Skills

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