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Clinical Research Associate (Closeout)

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 Clinical Operations. You will be responsible for monitoring clinical studies and ensuring compliance with regulatory requirements, while supporting investigators and site staff to ensure the safety and integrity of participants.

Main Responsibilities:

  • Perform closeout visits in accordance with study protocols and GCP guidelines.
  • Ensure timely and accurate collection of study data, including on-site source data verification.
  • Assist in the preparation of monitoring reports, ensuring compliance with internal and external standards.
  • Provide training to site staff on protocol requirements, data entry, and study procedures.
  • Communicate effectively with study teams and site personnel regarding study progress and challenges.
  • Identify and resolve issues that may impact the integrity of data or the rights and safety of participants.
  • Support the preparation for audits and inspections, maintaining compliance at the site level.

Requirements

About You:

Job Skills

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Local Pharmacovigilance Officer - Nordics region

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.

As a Mission Safety Member, you will be entrusted with specific responsibilities for product safety management (in pharmacovigilance) on behalf of Excelya clients.

This role offers the opportunity to contribute to meaningful projects, ensuring compliance and patient safety across diverse regulatory environments.

Main Responsibilities

Job Skills

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Safety Project 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.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Excelya Pharmacovigilance and Safety department. You will play a critical role in ensuring patient safety and driving excellence in pharmacovigilance, while enjoying a dynamic professional environment that fosters learning, collaboration, and career growth.

The Safety Project Leader is the project manager of the PV & Safety team, responsible for the implementation/provision of the activities/services described within a project/service agreement.

Safety Project Leaders are assuming full ownership of their assigned projects, which means they are fully responsible of regular contact with client and where applicable of budget (including budget forecast), invoicing, all legal issues (renewals, closures, extensions, scope etc.), quality and efficiency as well as audit readiness.

Job Skills

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Marketing Manager

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 is an exciting opportunity to lead a dynamic and forward-thinking Marketing team, driving meaningful impact within the clinical research industry. You will thrive in a stimulating environment that values innovation, collaboration, and continuous growth—both personal and professional.

As the leader for Marketing at Excelya, you will be responsible for defining and executing our global marketing strategy in full alignment with the company’s strategic objectives. In this key role, you will enhance Excelya’s brand presence, empower and equip our commercial teams with powerful marketing support, and lead your team in data-driven initiatives that shape the future of our organization.

Requirements

Main Responsibilities

Job Skills

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Clinical Quality Manager

posted by: spj_bot

About the Job

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 Manager, you will lead the development and implementation of quality strategies, manage audits and inspections, and collaborate closely with cross-functional teams to uphold the highest standards in clinical research.

Key Responsibilities

Job Skills

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Chargé(e) RH - Paie & Formation (CDD)

posted by: spj_bot

Dans le cadre d’un renfort temporaire, nous recherchons un(e) Chargé(e) RH Paie & Formation pour rejoindre notre équipe RH.

Ce poste offre une forte exposition aux sujets de paie et d’administration du personnel, complétée par un volet formation orienté coordination et développement des compétences.

Job Skills

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Statistical Programmer

posted by: spj_bot

Excelya is seeking a Statistical Programmer to join our innovative team dedicated to advancing clinical research. We pride ourselves on our core values of Audacity, Care, and Energy, and we believe that your expertise can help us make a significant impact in the healthcare domain.

As a Statistical Programmer, you will play a critical role in processing and analyzing clinical trial data. Utilizing your programming skills, you will ensure the accuracy and integrity of statistical outputs, contributing to the development of high-quality study reports.

Key Responsibilities:

  • Develop, validate, and maintain SAS programs for clinical data analysis and reporting.
  • Generate statistical tables, listings, and graphics in accordance with study specifications.
  • Collaborate with biostatisticians and data management teams to clarify deliverables and timelines.
  • Conduct quality control checks on programming outputs to ensure data consistency and compliance with regulatory standards.
  • Provide documentation and support for all programming activities, including maintaining version control.
  • Assist in the preparation of statistical analysis plans and regulatory submissions as needed.

Requirements

Qualifications

Job Skills

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Data Manager Research

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.

We are looking for a Data Manager - Research to join our talented team and play a key role in managing clinical data for various research projects, ensuring high quality and consistency across all data collected.

Main Responsibilities:

Organize and improve data quality per rules set by Data Owner.

  • Document data, metadata, lifecycle (catalog, contracts, process map)
  • Apply data quality rules, automate, monitor flows/reporting
  • Implement data integrity rules
  • Ingest data to cloud platform (GCP), communicate with stakeholders
  • Integrate new assets, Write data transfer specs; Perform quality controls
  • Handle data access/migration/archiving
  • Apply licensing terms for external data; Main contact for external data providers
  • Harmonize/standardize/prepare data for analysis
  • Share best practices with the DM community

Deliverables:

Job Skills

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Data Manager CMC

posted by: spj_bot

Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

About the Job

We are seeking a Data Manager – CMC (Chemistry, Manufacturing, and Controls) to support our commitment to high-quality products. In this vital role, you will oversee and ensure the integrity of data generated. You will work closely with research and project teams to deliver actionable insights through rigorous data management practices.

Main Activities:

Organize and improve data quality per rules set by Data Owner.

Job Skills

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Data Analyst R&D

posted by: spj_bot

About the Job

Excelya is looking for a dedicated Data Analyst R&D to join our dynamic Research and Development team. In this role, you will play an essential part in transforming complex data into actionable insights that drive our innovative projects and strategies.

As a Data Analyst, you will collaborate with cross-functional teams to analyze and interpret data from clinical trials, enabling informed decision-making and advancing our mission to improve patient outcomes.

Main Responsibilities:

  • Create data visualization solutions.
  • Define, specify, build, and/or improve:
    • Data structures necessary for storage and analysis: core models, business views, and ad hoc tables (in DBT).
    • Reports, dashboards, and data visualizations.
    • Unit tests and validation on data preparation, reports, and dashboards.

Deliverables:

  • Data preparation: core models, business views, and ad hoc tables (specifications + development and feeding of structures).
  • Data analysis and visualization: Data Report, Dashboard, Scoring board, etc.
    • Validation reports.

Requirements

About You

We are looking for passionate individuals who thrive in a collaborative environment and are eager to contribute to impactful projects.

Job Skills

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