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Principal Medical Writer USA

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.

Main responsabilities :

Job Skills

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Statistical Programmer

posted by: spj_bot

About the Role

Excelya is on the lookout for a talented Statistical Programmer to join our dynamic team. We are dedicated to upholding our core values of Audacity, Care, and Energy, and we believe that each member of our team plays a pivotal role in advancing clinical research through precise and insightful statistical analysis.

As a Statistical Programmer, you will leverage your expertise to analyze and interpret complex clinical data, ensuring our studies meet the highest standards of quality and compliance. This role not only allows you to showcase your programming skills but also provides the opportunity to collaborate with a diverse group of professionals committed to making a tangible impact in healthcare.

Key Responsibilities:

Job Skills

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CRA 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.

We are seeking a highly motivated and experienced Clinical Research Associate (CRA) Manager to lead our dedicated team of CRAs. In this role, you will be responsible for overseeing clinical trial activities and ensuring compliance with regulatory requirements while fostering a culture of excellence and collaboration within the team.

Main Responsibilities

Job Skills

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Clinical Trial Assistant

posted by: spj_bot

About the Job

Step into the world of clinical research with Excelya as a Clinical Trial Assistant. Here at Excelya, our values of Audacity, Care, and Energy not only shape our company culture but also your experience as an employee. This role offers you a unique opportunity to be involved in the critical processes of clinical trials while collaborating with a team that is dedicated to making a difference.

Main Responsibilities

Job Skills

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Clinical Research Associate - Oncology

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, particularly in the field of Oncology. As a Clinical Research Associate specializing in this area, you will play a crucial role in ensuring the successful conduct of oncology clinical trials, while supporting innovative cancer therapies that make a real difference in patients' lives.

Main Responsibilities:

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.

Main Responsibilities

  • Act as lead author for a range of regulatory and scientific documents (clinical protocols, Investigator Brochures, CTD modules, informed consent forms, etc.).
  • Coordinate cross-functional input (clinical, regulatory, biostatistics, data management, etc.) to ensure consistency and scientific accuracy of all deliverables.
  • Oversee and review the work of external vendors or contributing writers to ensure quality and compliance.
  • Ensure documents adhere to company SOPs, style guides, and international regulatory standards (EMA, FDA, ICH).
  • Manage timelines, planning, and document reviews efficiently to support submission milestones.

Requirements

About You

Job Skills

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Clinical Innovation Project 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.

The Clinical Innovation Project Manager will play a pivotal role in driving innovation within clinical trials, enhancing processes, and implementing best practices to improve study designs and outcomes. This is an excellent opportunity for proactive individuals who are passionate about advancing clinical research through innovative solutions.

Main Responsibilities

Job Skills

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Biological Sample 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.

The role of Biological Sample Manager is essential for ensuring the integrity and traceability of biological samples throughout the lifecycle of clinical trials. You will oversee the management of biological samples, ensuring compliance with regulatory requirements and study protocols.

Main Responsibilities:

Job Skills

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In-House Clinical Research Associate (Lab Specialist)

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, specifically focusing on laboratory functions within clinical trials. As an In-House Clinical Research Associate (Lab Specialist), you will play a critical role in ensuring the accuracy and integrity of laboratory data, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

  • Centralize and manage the monitoring of biological parameters across clinical studies
  • Transcribe laboratory parameters and local lab reference ranges into a dedicated English template
  • Review and respond to data management queries related to biological parameters, either within the template or directly in the eCRF (RAVE)
  • Identify and resolve discrepancies such as:
    • Missing data fields (e.g., lab parameter entered in eCRF but missing in the template)
    • Inconsistencies between the eCRF and the template
  • Ensure the correct use of measurement units and maintain data accuracy across all records

Requirements

Job Skills

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eCOA Lead Senior

posted by: spj_bot

About the Job

Excelya is looking for an experienced eCOA Lead Senior to join our innovative team! In this pivotal role, you will take the lead in managing electronic Clinical Outcome Assessments (eCOA) across clinical trials, ensuring that data collection meets the highest standards of quality, efficiency, and regulatory compliance.

As an eCOA expert, you will work collaboratively with various stakeholders to develop and implement strategies that enhance the clinical study experience for participants and investigators alike.

Main Responsibilities

  • Lead the design, implementation, and management of eCOA solutions for clinical trials.
  • Work closely with clinical project teams to deliver eCOA requirements aligned with objectives and timelines.
  • Coordinate the development and maintenance of eCOA systems, ensuring compliance with relevant regulatory frameworks.
  • Provide training and support to study teams on eCOA processes and tools.
  • Monitor eCOA data quality and provide insights for continuous improvement.
  • Collaborate with IT and third-party vendors to optimize eCOA technology and interfaces.

Requirements

About You

We are looking for a passionate individual who shares our values of audacity, care, and energy!

Job Skills

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