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Senior Patient Safety Specialist

posted by: spj_bot

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

We are looking for an experienced Patient Safety professional on a six month assignment. The successful candidate will contribute to clinical safety activities, signal detection and benefit-risk assessment for assigned products.

Key Responsibilities:

Job Skills

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Medical Affairs Consultant

posted by: spj_bot

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

We are looking for an experienced Medical Affairs Consultant / Therapeutic Area Medical Lead to provide medical leadership. The role focuses on ensuring the continuity of Medical Affairs activities, driving the execution of regional medical strategies and plans and fostering effective collaboration with regional and local medical teams to support ongoing projects and business objectives.

Key Responsibilities

  • Lead and execute Medical Affairs activities within dermatology and/or rheumatology.
  • Support regional medical strategies and operational medical plans across European markets.
  • Collaborate with Medical Heads, Medical Advisors and cross-functional stakeholders.
  • Coordinate scientific activities, including advisory boards, congresses and medical education initiatives.
  • Support evidence generation projects, including Real-World Evidence (RWE) and Non-Interventional Studies (NIS).
  • Engage with external medical experts and key opinion leaders (KOLs).
  • Ensure scientific accuracy, regulatory compliance and alignment with medical governance.
  • Provide operational continuity during temporary staffing gaps.

Job Skills

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Senior Clinical Project Manager

posted by: spj_bot

We are seeking an experienced Clinical Project Manager to oversee and coordinate clinical activities in pharmaceutical environment.
The role involves managing operational aspects of clinical trials, ensuring compliance with regulatory requirements, and acting as the primary interface between local stakeholders, investigators, vendors, and global teams.

This position requires strong autonomy, rigor, and excellent communication skills, with the ability to navigate cross‑functional environments.

Key Responsibilities :

1. Study Management

  • Lead and coordinate clinical trial activities at the local level from start‑up to close‑out.
  • Ensure local execution of global study plans in alignment with timelines and quality standards.
  • Serve as the key point of contact for local investigational sites and regional stakeholders.

2. Regulatory & Compliance Oversight

  • Ensure that clinical trial activities comply with local regulations, ICH‑GCP, and internal SOPs.
  • Coordinate local submissions to competent authorities and ethics committees when required.
  • Monitor adherence to regulatory timelines and manage any corrective actions.

Job Skills

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Clinical Outcome Assessment Lead

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.

We are seeking a Clinical Outcome Assessment (COA) Lead to drive COA strategy across innovative clinical development programs, ensuring the patient voice is integrated into clinical research and that meaningful outcomes are used to demonstrate the real impact of treatments on patients' lives.

Key Responsibilities:

  • Define and lead the COA strategy across clinical development programs.
  • Ensure the patient perspective is incorporated into study design and endpoint selection.
  • Select, develop, and validate appropriate COA instruments (PROs, ClinROs, ObsROs, PerfOs).
  • Provide scientific expertise on patient-centered outcomes and endpoint strategy.
  • Collaborate cross-functionally with Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs, HEOR, and external vendors.
  • Support regulatory submissions, publications, and scientific communications related to COA data.
  • Oversee COA implementation and data quality throughout clinical studies.

Requirements

Job Skills

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Medical Data Officer

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 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 Data Officer works in close collaboration with the Study Medical

Reviewer and participates in managing/reviewing the medical consistency of

reported clinical data to ensure that medical data in database are accurate, reliable

and analyzable.

Main Responsibilities

  1. Study Setup Tasks


* Protocol Review especially topics linked to safety management, specific data that could need to be coded, inclusion, selection criteria, study design, pathology and mechanism of action of the IMP


* Database specification review and User acceptance test on eCRF, and Database validation tools used for medical review

Job Skills

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Medical Information Solution Architect

posted by: spj_bot

Rejoignez Excelya, où l’Audace, le Soin et l’Energie définissent notre identité et notre manière de travailler. Nous croyons en la création de solutions ambitieuses et en un environnement inclusif, où la collaboration et le développement individuel vont de pair.

Dans le rôle de Medical Information Specialist, vous contribuez à l'optimisation des processus, des outils et des données tout en accompagnant les projets de transformation digitale et d'automatisation. Vous jouez un rôle d'interface entre les équipes métier et les équipes techniques afin d'améliorer l'efficacité opérationnelle et la qualité des services.

Responsabilités principales:

Job Skills

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Global Medical Advisor

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.

At Excelya, we are committed to delivering innovative clinical research solutions across Europe. As a Medical Advisor, you will play a pivotal role in providing expert medical and scientific guidance to support several projects internaly.

Key Responsibilities:

  • Provide medical expertise and advice throughout clinical development processes.
  • Support the preparation and review of medical and scientific content including manuscripts, posters, and presentations.
  • Engage with cross-functional teams to ensure scientific accuracy and relevance of clinical trial materials.
  • Assist in medical training, promotional material review, and respond to medical inquiries.
  • Stay up to date with therapeutic area trends and scientific advancements.

Requirements

Job Skills

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Chef de Projet RWE

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:

Job Skills

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Quality Coordinator

posted by: spj_bot

At Excelya, driven by Audacity, Care, and Energy, we invite you to join our team as a Clinical Quality Manager. This pivotal role focuses on overseeing the quality management system within clinical operations to ensure compliance with regulatory requirements and continuous improvement of clinical processes.

As a Clinical Quality Systems coordinator, you will be responsible for implementing & maintaining relevant QMS to assure the Commercial Operations groups are fully compliant and efficient with Global GxP’s

Your Main responsibilities :

Job Skills

preventive action systems coordinator control system act life science risk management quality management system documentation processes cross functional medical affair regulatory requirement project management biotechnology standards procedures service provider communication management management activities deviation management quality processes governance continuous improvement negotiation crisis prevention pharmaceutical manage quality operational document control training programs problem solve QMS risk register business units teamwork corrective actions chemistry collaborate collaboration operations manage deviations management deviation stakeholder management supply chain quality manager documentation management provider service clinical quality audit enthusiasm commercial operations management system consulting verbal communication skill policies quality quality management english french plans coordinate improving quality audits
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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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