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Global Quality Systems 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

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Senior Global Project Manager

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 Study Team Leader (STL), you will be responsible for leading global clinical study teams and ensuring the successful execution of international Phase I–III clinical trials from study synopsis to study archiving. You will oversee timelines, budget, quality, CROs, vendors, and cross-functional teams while ensuring compliance with regulatory requirements and GCP standards.

Key Responsibilities

Job Skills

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Clinical Study Assistant

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 Clinical Trial Assistant (CTA) supports the planning and execution of Phase 1/2 clinical trials across multiple countries by providing operational, administrative, and logistical assistance. Working closely with the Project Director and clinical study leaders, the CTA helps ensure smooth study coordination, high-quality documentation, and effective communication with CROs and external vendors in a fast-paced biotech setting, and reports directly to the Project Director.

Main Responsibilities:

  • Supports daily clinical trial execution and logistics
  • Organizes team meetings and cross-functional coordination
  • Maintains Trial Master File (TMF) quality and completeness
  • Manages essential study and regulatory documents
  • Supports study start-up and vendor/CRO coordination
  • Assists with contracts, work orders, and purchase orders
  • Ensures effective communication and tracks key updates/decisions

Requirements

Job Skills

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Manager/Sr. Manager - MDM (Pharma / Medical Devices)

posted by: spj_bot

Tiger Analytics is an advanced analytics consulting firm. We are the trusted analytics partner for several Fortune 100 companies, enabling them to generate business value from data. Our consultants bring deep expertise in Data Science, Machine Learning, and AI. Our business value and leadership have been recognized by various market research firms, including Forrester and Gartner.

We are seeking an experienced Lead - MDM to join a managed engagement, specifically focused on Master Data Management (MDM) initiatives. This role requires a Subject Matter Expert who possesses deep domain knowledge in the Medical Devices or Pharmaceutical industry and a proven track record of successfully navigating and delivering MDM projects.

RESPONSIBILITIES:

Job Skills

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Clinical Research Associate

posted by: spj_bot

About the Job

Excelya is looking for a motivated Clinical Research Associate to join our dedicated Clinical Operations team. As part of our company values of Audacity, Care, and Energy, you will contribute to advancing innovative clinical trials that improve patient outcomes.

In this role, you will oversee all aspects of clinical trials from site initiation to close-out, ensuring compliance with protocols and regulations while building strong relationships with study investigators and site staff.

Key Responsibilities:

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

Requirements

Requirements:

Job Skills

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Associate Director- Program Manager (Pharma / Medical Devices)

posted by: spj_bot

Tiger Analytics is an advanced analytics consulting firm. We are the trusted analytics partner for several Fortune 100 companies, enabling them to generate business value from data. Our consultants bring deep expertise in Data Science, Machine Learning, and AI. Our business value and leadership have been recognized by various market research firms, including Forrester and Gartner.

We are seeking an experienced Program Manager with a strong background in Data & Analytics and deep domain expertise in the Pharmaceutical and/or Medical Devices industry. The ideal candidate will have a proven track record of leading large-scale, cross-functional data transformation programs and managing complex multi-vendor delivery environments while partnering with senior business and technology stakeholders.

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.

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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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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Pharmacovigilance manager

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:

  • Ensure quality review of safety data received from partners before entry into the safety database (completeness, accuracy, compliance).
  • Oversee serious adverse event (SAE) management, including coordination and review of case narratives.
  • Perform quality checks of aggregate reports (e.g., DSURs).
  • Support PV setup for clinical studies and implementation of safety processes.
  • Manage PV documentation in eTMF to ensure inspection readiness.
  • Contribute to the setup of post-marketing PV systems.
  • Collaborate with internal teams and partners to ensure efficient and compliant safety operations.

Requirements

Job Skills

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Pharmacovigilance Associate

posted by: spj_bot

At Excelya, we embody Audacity, Care, and Energy in all that we do. We offer a dynamic and inclusive environment where innovation and collaboration drive success.

The Pharmacovigilance Associate ensures drug safety compliance by managing safety reports, supporting risk management activities, and communicating with stakeholders. The role requires a life sciences background, pharmacovigilance experience, and strong organizational, communication, and teamwork skills.

Main responsibilities:

  • Ensure compliance with pharmacovigilance regulations, company procedures, and quality standards.
  • Manage Individual Case Safety Reports (ICSRs) in accordance with local legislation and internal guidelines.
  • Communicate relevant safety information to health authorities, stakeholders, and external partners.
  • Support safety surveillance activities, including risk management, safety issues, and product-related alerts.
  • Contribute to the creation and maintenance of quality documents and ensure proper documentation practices.
  • Deliver training on pharmacovigilance processes to internal employees.
  • Collaborate with third parties involved in pharmacovigilance activities.
  • Promote adherence to corporate policies, values, and compliance standards, including HSE requirements.

Requirements

Job Skills

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