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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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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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Business Analyst - Gestion Documentaire Pharma

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 offers a great opportunity to contribute to a strategic EDMS transformation program within a global Quality environment. You will play a key role in analyzing complex data landscapes, supporting data-driven decision-making, and shaping the document migration strategy, while working in a highly collaborative and intellectually stimulating environment.

Key responsibiliities :

Job Skills

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Senior Medical Writer

posted by: spj_bot

About the Job

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 in Medical Affairs. 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.

The Medical Writer is in charge of producing medical writing deliverables (both regulatory and medical communication documents).

The Medical Writer will draft the reference documents for clinical studies, other research involving the human person and research not involving the human person and which must be part of the authorization request file from the Competent Authorities, such as the protocol, the summary of the protocol, the information and consent form, the observation booklet and any patient questionnaires and the investigator brochure.

The Medical Writer will work alongside healthcare professionals, project managers, statisticians and other company functional groups to produce the medical writing deliverables.

Main Responsibilities:

 

Job Skills

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Medical Writer

posted by: spj_bot

About the Job

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 in Medical Affairs. 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.

 

The Medical Writer is in charge of producing medical writing deliverables (both regulatory and medical communication documents).

The Medical Writer will draft the reference documents for clinical studies, other research involving the human person and research not involving the human person and which must be part of the authorization request file from the Competent Authorities, such as the protocol, the summary of the protocol, the information and consent form, the observation booklet and any patient questionnaires and the investigator brochure.

The Medical Writer will work alongside healthcare professionals, project managers, statisticians and other company functional groups to produce the medical writing deliverables.

 

Main Responsibilities

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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