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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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Clinical Data Manager (I)

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 Data Management. 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 Clinical Data Manager is responsible for performing Data Management tasks per client work orders to high regulatory standards and Excelya Group SOPs. 

Main Responsibilities

·       Deeply acknowledges and strictly follows Excelya and Client’s SOPs, guidelines and appropriate local and international legislation.

·       CDMI works under the supervision of more senior staff (Manager or Senior CDM).

·       Responsible for data cleaning, data review, discrepancy management and data reconciliation activities on the studies assigned to him/her.

·       Work closely with the Lead Data Manager responsible for the study.

·       Generate study metrics and status reports within and across several studies. 

Job Skills

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Clinical Data Management Specialist

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 offers the opportunity to work directly on a proprietary EDC platform built on Salesforce, supporting clinical studies from study build through close-out while contributing to product support and defect management.

Key Responsibilities:

  • Configure, maintain, and support clinical studies within the EDC platform throughout the study lifecycle.
  • Participate in study build activities from initial setup to study close-out.
  • Implement and maintain study configurations while ensuring quality, accuracy, and consistency.
  • Investigate, troubleshoot, and resolve EDC system issues and defects.
  • Collaborate with Product Owners, SMEs, and Engineering teams to address technical and operational challenges.
  • Execute testing, validation, and quality assurance activities following system updates and defect fixes.
  • Support clinical data management and EDC development/configuration requirements in collaboration with internal teams.
  • Provide client support, handle operational requests, and contribute to continuous product improvement initiatives.

Requirements

Job Skills

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eTMF Specialist

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.

The successful candidate will work closely with Clinical Project Managers, Clinical Trial Associates, Clinical Operations teams, and CRO partners to ensure TMFs remain complete, compliant, and inspection-ready throughout the study lifecycle.

Key Responsibilities:

Job Skills

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Clinical Data Systems Lead (Oracle DMW)

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.

This role offers an exciting opportunity to support the systems used for clinical data cleaning and review activities. As a Business System Expert, you will act as the bridge between Clinical Data Management, Medical Review, IT, QA, and system vendors, ensuring optimal performance, compliance, and adoption of clinical data management platforms.

Key Responsibilities

Job Skills

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Clinical EDC Systems Lead (Oracle Clinical One)

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.

This role offers an exciting opportunity to support the systems used for clinical data collection and management in clinical trials. As a Business System Expert, you will act as the bridge between Clinical Data Management, IT, QA, and system vendors, ensuring the performance, compliance, and continuous improvement of Oracle Clinical One and related EDC platforms.

Key Responsibilities

Job Skills

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Clinical Analytics Platform Lead (SAS & Cloud)

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.

This role offers an exciting opportunity to support the analytical platforms used for the design and statistical analysis of clinical trial data. As a Business System Expert, you will act as the link between Biostatistics, Statistical Programming, IT, QA, and external vendors, ensuring the performance, compliance, and continuous improvement of critical clinical systems.

Key Responsibilities

Job Skills

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Senior Clinical Scientist Immunology

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 support the Study Medical Manager in the planning, execution, analysis, and reporting of clinical studies from study start-up through study close-out. You will contribute to protocol development, medical data review, study documentation, and cross-functional collaboration to ensure high-quality clinical trial delivery in compliance with regulatory requirements.

Key Responsibilities

Job Skills

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Oracle Programmer (1)

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 Data Management. 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 Oracle Programmer is responsible for providing Oracle Programming input for Data Management activities dedicated to one Sponsor. They are responsible for ensuring all clinical programming aspects per Client’s SOPs are delivered to high quality.

Main Responsibilities

•Work closely with the different study stakeholders internally

•Responsible for programming using Oracle tools (DMW, LSH)

•Good understanding of SDTM & Data set generations as per the specifications in DMW.

•Responsible for setting up for external data vendors integration from specifications in DMW.

•Responsible for Transformation mapping as per the specifications.

•Responsible for managing external data loading and integrations in DMW.

•Responsible for VC/PD programming in DMW

Requirements

About You

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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