Excelya

Clinical Research

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

Clinical Research Associate

Systems Engineer

• Excelya recherche un dispositif médical innovant de classe III dans un environnement R&D exigeant et fortement réglementé.
• Nous recherchons un(e) Ingénieur(e) Système avec une dominante software pour rejoindre un projet stratégique dans le domaine des dispositifs implantables cardiovasculaires.
• Ingénierie système & exigences - Rédaction et structuration des exigences système et software
• Traduction des besoins utilisateurs en exigences techniques
• Gestion de la traçabilité des exigences
• Participation à l’architecture système (interaction hardware/software)
• Contribution aux revues de conception
• Développement & conformité réglementaire - Application du cycle en V
• Participation aux activités de Vérification & Validation (V&V)
• Contribution au Design History File (DHF)
• Travail en conformité avec : Règlement (UE) 2017/745
• ISO 13485
• ISO 14971
• IEC 62304
• Gestion des risques - Participation aux analyses de risques (AMDEC / FMEA / FTA)
• Analyse d’impact des modifications software

Ingénieur Système, Dispositif Médical – Classe III

Compliance

• **Main Responsibilities:**
• - Provide regulatory advice on advertising and promotion of pharmaceutical products and medical devices across international markets.
• - Review and approve promotional materials to ensure compliance with local, regional, and international regulations.
• - Collaborate with cross-functional teams, including marketing, legal, and medical affairs, to develop compliant promotional strategies that resonate with diverse audiences.
• - Monitor and analyze changes in global regulatory requirements related to advertising and promotion, providing timely updates and guidance to stakeholders.
• - Engage with regulatory authorities and industry associations to maintain positive relationships and facilitate the approval process of promotional content.

International Regulatory Affairs Officer – Advertising & Promotion

Manager

• **Main Responsibilities**
• - Ensure timely, cost-effective, and quality-compliant delivery of clinical study supplies for CHC clinical studies
• - Coordinate the sourcing of clinical study drug products (placebo, investigational and marketed products) in collaboration with CMOs, CHC Development Centers, and IA sites
• - Manage clinical supplies budget, including forecasting and invoice tracking with CMOs
• - Oversee CMOs to ensure effective execution of clinical supply operations in line with study requirements
• - Define and implement the optimal clinical supply strategy for each study and ensure clear communication to study teams
• - Monitor clinical supply production plans and ensure alignment with study timelines
• - Lead Operational Supply Meetings with CMOs to track progress, anticipate issues, and adjust supply strategies to mitigate risks
• - Review and contribute to study-related documentation (protocols, pharmacy manuals, monitoring and communication plans) to optimize supply usage
• - Ensure proper oversight of clinical supply documentation within the (e)TMF
• - Identify and mitigate clinical supply-related risks as part of the study risk management approach
• - Contribute, as needed, to broader clinical study management activities, including process improvement and coordination of external collaborations

Clinical Study Supply Manager

Clinical Operations

• Coordinate and support clinical project teams, including identification and alignment of Clinical sub-team members
• Actively contribute to project and clinical team meetings, ensuring effective follow-up and communication
• Coordinate Clinical sub-team meetings and ensure action tracking and issue resolution
• Lead coordination of Clinical CTD task forces and contribute to PAI preparation, conduct, and closure
• Collaborate closely with GCDSE on project execution, team organization, and governance
• Ensure clear team direction, alignment with franchise and project strategy, timeline adherence, and proactive risk and escalation management
• Contribute to clinical operational strategy documents (e.g. TPP, CDP)
• Use clinical project analytics to identify, monitor, and communicate risks, issues, and alerts
• Ensure timely and accurate planning and reporting, including project plans, timelines, budgets, and operational updates
• Support platform and organizational initiatives by contributing to process improvement, acting as a subject matter expert, and delivering training related to job certification

Clinical Operations Lead

• Coordinate the local clinical team involved in national and international oncology trials.
• Participate in the development of study documents (protocols, ICFs, CRFs, etc.).
• Manage the study budget and timeline to ensure efficient execution.
• Oversee site and vendor selection, activation, and performance throughout the study.
• Ensure successful patient recruitment through coordinated clinical activities.
• Deliver study results with high quality, on time and within budget.
• Manage regulatory submissions and administrative follow-up in compliance with ICH-GCP and local regulations.
• Lead feasibility assessments and investigator selection.
• Provide transversal management and operational oversight of CRAs.

Clinical Project Manager

QA Engineer

• **Key Responsibilities**
• In this role you are expected to:
• - Lead and support **internal **and **external audits** and **inspections**, ensuring proper **preparation**, **execution**, **reporting**, and **follow-up**.
• - Conduct and oversee **Risk Assessments** and **Risk Management** activities across **QA processes**. Also manage **vendor qualification, requalification**,and **GMP/GDP-related audits**.
• - Maintain and enhance the **Quality Management System (QMS)**, including **Change Controls**, **Deviations, CAPAs**, and **documentation governance**.
• - Contribute to **writing**, **updating**, and **reviewing QMS documents**.
• In addition you will need to:
• - Oversee the **documentation system**,** ensuring compliance, accessibility**, and **version control**.
• - **Develop**, **monitor**, and **report Quality KPIs**, contributing to **Quality Management Reviews**.
• - Maintain **QA Agreements (QAAs)**, **supplier/vendor records**, the **Site Master File (SMF)**, and the **Quality Manual**.
• - Collaborate with QA team members on **annual quality review activities**, **audit planning, training planning**, and other core QA processes.
• Finally, you will be required to:
• - Contribute to the **annual training plan**,** deliver internal training**, and promote a strong quality culture.
• - Drive **cross-functional** collaboration to ensure **continuous improvement **and timely **CAPA implementation**.
• - Contribute to **people management** of the **local QA team** in close collaboration with the GQA Director

Senior Quality Assurance – Vendor Manager

• Provide medical leadership for clinical development programs in immunology, ensuring scientific and regulatory excellence
• Lead and contribute to clinical document development, including protocols, informed consent forms (ICFs), amendments, and key regulatory documents
• Deliver medical expertise to support real-world data pressure testing, operational feasibility, and study planning
• Act as a medical point of contact for Health Authorities, Ethics Committees, investigators, CROs, and internal study teams
• Prepare and actively participate in investigator meetings, monitoring meetings, and cross-functional study forums
• Lead and support the set-up, governance, and operation of clinical committees (Steering Committee, Data Monitoring Committee, Adjudication Committee), including charters, meetings, and documentation
• Provide medical guidance, training, and oversight to internal teams, CROs, and investigators throughout the study lifecycle
• Contribute medical input to study plans, CRF design, deviation management, and risk mitigation strategies
• Support data review and medical validation, including clinical case review, patient profile assessment, and narrative validation
• Review and endorse Statistical Analysis Plans and contribute to key result interpretation
• Support Clinical Study Report (CSR) development through drafting and review of key sections
• Prepare for and respond to audits and inspections, and review draft scientific publications

Clinical Research Director

• Contribute to RFP, SOW, and IRT risk assessment/mitigation plan.
• Organize kick-off and alignment meetings with stakeholders.
• Define IRT project requirements, data transfer specifications, and communication plan.
• Validate IRT study documents (protocol, plans, manuals) and microplanning.
• Coordinate User Acceptance Testing (UAT) and review test plans for patient management.
• Oversee IRT vendor activities, meeting minutes, and issue logs.
• Ensure proper data transfer, reconciliation, and final quality control before IRT closure.
• File IRT study documentation in eTMF and contribute to lessons learned review.

Vendor Manager

Medical writer

• **About the Job**
• We are seeking a **Senior Medical Writer** to provide medical and scientific expertise required for the successful completion of Excelya’s projects.
• **Your Mission:**
• - Produce high‑quality scientific content in clinical medical writing (including clinical protocols, informed consent forms, clinical study reports, lay summaries), regulatory medical writing (CTDs 2.4-2.7) and medical communications (manuscripts, abstracts, posters, and presentations).
• - Ensure accuracy, clarity, and compliance across all medical and scientific deliverables.
• - Collaborate with cross‑functional teams and engage with external scientific stakeholders.
• - Deliver medical training and scientific support to internal teams and clients.
• - Experience across all clinical study phases with a focus on Phase I-III.

Senior Medical Writer

Designer

• **Main Responsibilities**
• - Understand and analyze business use cases related to the upgrade of a referential application.
• - Design, document, and maintain detailed test cases for both technical and functional application evolutions.
• - Execute test cases, record test evidence (Xray), and ensure compliance of the updated functionalities.
• - Collaborate with multidisciplinary teams, including data managers, reference data teams, and IT (DSI), to clarify requirements and resolve issues.
• - Draft and maintain documentation linked to application updates (user guides, training materials, business rule descriptions) in both French and English.
• - Develop a functional understanding of data‑management applications and their interdependencies.
• - Implement data integrity rules in accordance with project needs.
• - Participate actively in Agile ceremonies and contribute to continuous improvement of testing processes.

Test Case Designer

• Lead and coordinate the operational aspects of assigned clinical studies, including study start-up, site management, and monitoring activities to ensure compliance with protocols and GCP standards.
• Act as the primary liaison between project teams and clinical sites, ensuring effective communication and collaboration.
• Oversee the planning and execution of monitoring visits, including preparation of visit reports and follow-up on findings.
• Train and mentor Clinical Research Associates (CRAs) and ensure they are aligned with project goals and objectives.
• Review study-related documents for accuracy and completeness, ensuring regulatory compliance throughout the study lifecycle.
• Support the management of study budgets and timelines, providing regular updates to project stakeholders.
• Ensure that site staff are knowledgeable about study protocols and GCP requirements through ongoing training and support.
• Facilitate problem-solving and risk assessment to address issues that may arise during the study.

• Prepare, compile, and submit regulatory dossiers (initial submissions, variations, renewals, responses to authorities’ questions).
• Ensure compliance of documentation and activities with applicable regulations (EU, ICH, national authority guidelines).
• Support regulatory strategy throughout product lifecycle (development, registration, post‑approval).
• Interface with health authorities, ethics committees, and internal/external stakeholders.
• Track regulatory timelines, approvals, and commitments to ensure smooth project progression.
• Review and validate labeling, artwork, SmPC/PIL, and promotional materials as per regulatory standards.
• Participate in the preparation of audits and inspections related to regulatory aspects.
• Maintain accurate documentation and records in line with internal SOPs and regulatory requirements.
• Identify regulatory risks and propose solutions or mitigation strategies.

Regulatory Affairs Officer

• **Main Responsibilities:**
• - Conduct internal and external audits related to clinical research (GCP, investigator sites, vendors, systems).
• - Prepare audit plans, perform risk assessments, and document findings in detailed audit reports.
• - Follow up on corrective and preventive actions (CAPA) and ensure timely and effective implementation.
• - Support teams during regulatory inspections (EMA, ANSM, FDA or other competent authorities).
• - Review and contribute to the development of SOPs, quality documents, and clinical processes.
• - Provide training and quality guidance to operational teams to reinforce compliance and best practices.
• - Monitor regulatory and industry updates (ICH‑GCP, EU regulations, national guidance) and assess their impact.
• - Participate in continuous improvement initiatives to strengthen the quality management system.
• - Maintain accurate and compliant documentation according to QA standards.

Clinical Quality Assurance Officer

Recruitment

• 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 **Talent Acquisition**. 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.
• As a **Talent Acquisition Partner**, you’ll join a collaborative and forward-thinking team that plays a pivotal role in shaping Excelya’s growth across the globe. Working closely with hiring managers and operational teams, you’ll lead high-volume and fast-paced recruitment efforts for critical roles in clinical research. This is a unique opportunity to bring your expertise to a fast-paced, mission-driven environment where your ideas are valued, your development is supported, and your work directly contributes to advancing healthcare innovation.
• **Main Responsibilities**
• - Lead end-to-end recruitment for complex and niche roles, ensuring a high-quality candidate and stakeholder experience throughout the process.
• - Partner closely with hiring managers and business leaders to understand talent needs, define role requirements, and develop effective hiring strategies.
• - Proactively source, engage, and nurture top talent through a variety of channels, including direct sourcing, talent pools, and market mapping.
• - Build and maintain strong talent pipelines, including active and warm candidate pools, to support current and future hiring needs.
• - Use data and market insights to inform recruitment decisions, influence stakeholders, and continuously improve sourcing strategies.
• - Manage recruitment processes in line with KPIs and SLAs, ensuring timely delivery and high standards of quality and compliance.
• - Collaborate with internal and external stakeholders to drive alignment, share best practices, and contribute to broader talent acquisition initiatives across EMEA.

Clinical Research Associate

Ingénieur Système, Dispositif Médical – Classe III

International Regulatory Affairs Officer – Advertising & Promotion

Clinical Study Supply Manager

Clinical Operations Lead

Clinical Project Manager

Senior Quality Assurance – Vendor Manager

Clinical Research Director

Vendor Manager

Senior Medical Writer

Test Case Designer

Clinical Operations Lead

Regulatory Affairs Officer

Clinical Quality Assurance Officer

Senior Talent Acquisition Partner BeNe