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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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Clinical Operations Consultant

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:

  • Support the operational management of ongoing clinical studies.
  • Contribute to study oversight and coordination activities.
  • Collaborate with internal and external stakeholders, including CRO partners and study teams.
  • Ensure compliance with applicable regulations, GCP and study procedures.
  • Assist with workload management and operational delivery during a peak activity period.

Requirements

Job Skills

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Clinical Scientist Oncologie

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 be a key player in supporting clinical trials and contributing to the advancement of clinical research projects.

You will work alongside cross-functional teams to ensure clinical studies are conducted in accordance with protocol, regulatory requirements, and company standards. Your role will involve reviewing clinical data, supporting medical monitoring activities, and contributing to the development and review of clinical trial documents.

  • Support clinical trial activities from study start-up to close-out, ensuring adherence to clinical and regulatory standards.
  • Contribute to the preparation and review of protocols, informed consent forms, and amendments.
  • Perform medical review of clinical data, including patient profiles and adverse event narratives.
  • Collaborate with pharmacovigilance, clinical operations, and biostatistics teams for data review and interpretation.
  • Assist in medical writing and review of study-related documents such as clinical study reports and briefing documents.
  • Ensure proper documentation and filing of study-related materials into Trial Master Files.
  • Support preparation for audits, inspections, and regulatory submissions.

Requirements

About You

Job Skills

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Clinical Scientist

posted by: spj_bot

About the Job

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 be a key player in supporting clinical trials and contributing to the advancement of clinical research projects.

You will work alongside cross-functional teams to ensure clinical studies are conducted in accordance with protocol, regulatory requirements, and company standards. Your role will involve reviewing clinical data, supporting medical monitoring activities, and contributing to the development and review of clinical trial documents.

  • Support clinical trial activities from study start-up to close-out, ensuring adherence to clinical and regulatory standards.
  • Contribute to the preparation and review of protocols, informed consent forms, and amendments.
  • Perform medical review of clinical data, including patient profiles and adverse event narratives.
  • Collaborate with pharmacovigilance, clinical operations, and biostatistics teams for data review and interpretation.
  • Assist in medical writing and review of study-related documents such as clinical study reports and briefing documents.
  • Ensure proper documentation and filing of study-related materials into Trial Master Files.
  • Support preparation for audits, inspections, and regulatory submissions.

Requirements

Job Skills

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Scientifique PKPD

posted by: spj_bot

About the Job

Excelya is seeking a skilled Pharmacokineticist to join our dynamic team. You will play a key role in supporting the pharmacokinetic (PK) evaluation of clinical trials across all phases, contributing to drug development and regulatory submissions.

The consultant will contribute to pharmacokinetics (PK) activities across Phase I to Phase III clinical trials, ensuring the timely delivery of high‑quality PK analyses, interpretations, and documentation.

Key Responsibilities:

Job Skills

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Medical Advisor (MDA)

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 in Regulatory. 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:

Job Skills

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Vendor Manager Biocollection

posted by: spj_bot

About the Job

Join Excelya as a Vendor Manager Biocollection, where Audacity, Care, and Energy define who we are and how we work. This role is essential in managing vendor relationships specifically related to biocollection processes to ensure the highest quality and compliance in clinical studies.

Main Responsibilities:

  • Manage and coordinate biocollection vendors throughout all phases of clinical trials.
  • Negotiate contracts, monitor vendor performance, and ensure compliance with regulatory requirements and study protocols.
  • Collaborate closely with internal teams and external partners to align expectations and timelines.
  • Ensure proper documentation, data transfer, and timely resolution of issues related to biocollection activities.
  • Support risk assessment and mitigation plans regarding biocollection vendors.
  • Contribute to study kick-off meetings, vendor selection processes, and contract management.

Requirements

About You

Job Skills

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Scientifique PK/PD

posted by: spj_bot

About the Job

Excelya is seeking a skilled Pharmacokineticist to join our dynamic team. You will play a key role in supporting the pharmacokinetic (PK) evaluation of clinical trials across all phases, contributing to drug development and regulatory submissions.

The consultant will contribute to pharmacokinetics (PK) activities across Phase I to Phase III clinical trials, ensuring the timely delivery of high‑quality PK analyses, interpretations, and documentation.

Key Responsibilities:

Job Skills

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Pharmacokineticist

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We are committed to creating innovative solutions and fostering a collaborative and inclusive work environment.

The consultant will contribute to pharmacokinetics (PK) activities across Phase I to Phase III clinical trials, ensuring the timely delivery of high‑quality PK analyses, interpretations, and documentation. This role involves close collaboration with clinical, non-clinical, and modeling teams to deliver robust pharmacokinetic data and modeling outputs that inform drug dosing strategies and regulatory submissions.

Main responsibilities:

Job Skills

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Senior Clinical Project Manager

posted by: spj_bot

Senior Clinical Project Manager

At Excelya, we are seeking an experienced Senior Clinical Project Manager to lead and oversee complex clinical trials from initiation to close-out, ensuring adherence to timelines, budgets, and quality standards. This role offers the opportunity to work within a vibrant team focused on delivering impactful clinical research in a collaborative and innovative environment.

Key Responsibilities:

    • Lead and coordinate oncology clinical studies from set‑up to close‑out
    • Contribute to protocol and clinical document writing
    • Manage timelines, budgets, regulatory submissions, and study deliverables
    • Coordinate internal and external stakeholders (sites, CRAs, partners)
    • Ensure patient safety, data quality, and regulatory compliance
    • Organize project meetings, reporting, and performance tracking
    • Supervise and support project teams (CRAs, study coordinators)

Requirements

Requirements:

Job Skills

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