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Local Safety Partner

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 Safety Partner, you will be responsible for supporting and implementing product safety strategies for a portfolio of products primarily used in autoimmune diseases. Working closely with local and global stakeholders, you will contribute to the continuous monitoring of product benefit-risk profiles, support signal management activities, and ensure compliance with pharmacovigilance requirements while helping identify unmet patient and healthcare professional needs.

Main responsibilities :

Job Skills

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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.

Duration: 1-3 months (freelance).

Main Responsibilities:

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

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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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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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Clinical Research Associate

posted by: spj_bot

About the Job

Excelya is looking for a motivated Clinical Research Associate 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:

    • Conduct site initiation visits, monitoring visits, and close-out visits.
    • Ensure site compliance with study protocols, ICH-GCP guidelines, and applicable regulations.
    • Communicate effectively with study sites to facilitate the trial process and address any issues that arise.
    • Review and verify study-related documents and data for accuracy and completeness.
    • Monitor patient safety and data integrity throughout the study.
    • Assist in preparing for audits and regulatory inspections.
    • Provide regular updates to project managers and stakeholders about site progress and challenges.

Requirements

Requirements:

Job Skills

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Pharmacovigilance 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.

This role is an exciting opportunity to contribute to a dynamic, ambitious team. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities:

  • Ensure quality review of safety data received from partners before entry into the safety database (completeness, accuracy, compliance).
  • Oversee serious adverse event (SAE) management, including coordination and review of case narratives.
  • Perform quality checks of aggregate reports (e.g., DSURs).
  • Support PV setup for clinical studies and implementation of safety processes.
  • Manage PV documentation in eTMF to ensure inspection readiness.
  • Contribute to the setup of post-marketing PV systems.
  • Collaborate with internal teams and partners to ensure efficient and compliant safety operations.

Requirements

Job Skills

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