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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:

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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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Sr Manager/Associate Director - Analytics Consulting (Pharma/LifeScience)

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. Various market research firms, including Forrester and Gartner, have recognized our business value and leadership. We solve complex analytical problems at scale and have built a reputation for delivering valuable data-driven solutions across various industries, including Pharma and Life Sciences.

We have an urgent requirement for a Commercial Data & Analytics SME/Lead role based out of the Foster City office. This is a strategic business-facing role, not a pure engineering/reporting position.

Job Skills

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Clinical Scientist Oncologie

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 be a key player in supporting clinical trials and contributing to the advancement of clinical research projects.

You will work alongside cross-functional teams to ensure clinical studies are conducted in accordance with protocol, regulatory requirements, and company standards. Your role will involve reviewing clinical data, supporting medical monitoring activities, and contributing to the development and review of clinical trial documents.

  • Support clinical trial activities from study start-up to close-out, ensuring adherence to clinical and regulatory standards.
  • Contribute to the preparation and review of protocols, informed consent forms, and amendments.
  • Perform medical review of clinical data, including patient profiles and adverse event narratives.
  • Collaborate with pharmacovigilance, clinical operations, and biostatistics teams for data review and interpretation.
  • Assist in medical writing and review of study-related documents such as clinical study reports and briefing documents.
  • Ensure proper documentation and filing of study-related materials into Trial Master Files.
  • Support preparation for audits, inspections, and regulatory submissions.

Requirements

About You

Job Skills

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Clinical Scientist

posted by: spj_bot

About the Job

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 be a key player in supporting clinical trials and contributing to the advancement of clinical research projects.

You will work alongside cross-functional teams to ensure clinical studies are conducted in accordance with protocol, regulatory requirements, and company standards. Your role will involve reviewing clinical data, supporting medical monitoring activities, and contributing to the development and review of clinical trial documents.

  • Support clinical trial activities from study start-up to close-out, ensuring adherence to clinical and regulatory standards.
  • Contribute to the preparation and review of protocols, informed consent forms, and amendments.
  • Perform medical review of clinical data, including patient profiles and adverse event narratives.
  • Collaborate with pharmacovigilance, clinical operations, and biostatistics teams for data review and interpretation.
  • Assist in medical writing and review of study-related documents such as clinical study reports and briefing documents.
  • Ensure proper documentation and filing of study-related materials into Trial Master Files.
  • Support preparation for audits, inspections, and regulatory submissions.

Requirements

Job Skills

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Clinical Research Associate (CRA) - Oncology - Clinical Operations

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.

In this hands-on role, you will support site activation, documentation, regulatory submissions, and ensure TMF quality and inspection readiness. Working closely with cross-functional teams, you will help drive efficient study execution while maintaining full compliance with regulations and internal standards.

Main Responsibilities:

Job Skills

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