Clinical Trial Associate

Il y a 7 mois


RueilMalmaison, France Novartis Temps plein

390807BR

**Clinical Trial Associate (H/F)**:
France

**About the role**

Location: Rueil-Malmaison, Paris #LI-Hybride
The Clinical Trial Associate (CTA) supports SSO Study Start-Up Manager and SSO Clinical Project Manager in assigned studies during set-up and whole study lifecycle in compliance with Novartis processes, GCP/ICH and regulatory requirements.
Your responsibilities will be but are not limited to:

- Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable
- Sets-up systems
- Supports vendor selection, TPRM process, SIM entries
- IF and TMF management (country and site TMF); set-up and maintenance according to regulatory and Novartis requirements; document oversight and tracking
- Supports Vendor set-up as applicable
- Checks site “Green Light” completeness and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
- Supports preparation and translation of ICF into local languages (including vendor management if necessary)
- Supports preparation of patient facing material
- Responsible for completeness of uploaded trial related documents into CREDI/SUBWAY, including archiving of paper TMFs
- Supports country SSU strategy in close collaboration with SSU Team Lead and SSU Managers to ensure SSU timelines and deliverables are met according to country commitments

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Role Requirements**

Essential Requirements:

- Commercial or medical training (e.g., vocational qualification, bachelor’s degree), Medical records administrator or equivalent education, preferably with experience in clinical operations
- Fluent in both written and spoken English, local language as needed
- Ideally several years of working experience with 1+ years' of experience in clinical operations
- Understanding of clinical drug development with particular emphasis on trial set-up, and contracting

Desirable Requirements:

- Profound knowledge of MS Excel, MS Word, MS PowerPoint, ideally knowledge in SAP
- Understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our

Novartis is able to offer relocation for this role.

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
**Division**

Development

**Business Unit**

GCO GDD

**Work Location**

Rueil-Malmaison

**Company/Legal Entity**

Novartis Pharma France SAS

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes



  • Rueil-Malmaison, France Labcorp Temps plein

    **Clinical Research Associate II / CRA II** Location: Paris home office, France A formula for clinical innovation: Labcorp Drug Development. With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 60,000 employees advance life-changing medicines across a wide range of therapeutic areas - improving health...


  • Rueil-Malmaison, France Bristol-Myers Squibb Temps plein

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Clinical Research Associate

    il y a 2 semaines


    Rueil-Malmaison, France Labcorp Temps plein

    **Get ready to redefine what's possible and discover your extraordinary potential at Labcorp Drug Development. Here, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll...

  • Intern Cra

    il y a 3 semaines


    Rueil-Malmaison, France Labcorp Temps plein

    As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for...

  • Start-up Associate, France

    il y a 3 semaines


    Rueil-Malmaison, France Labcorp Temps plein

    **Job Description**: Labcorp Drug Development has supported the pharmaceutical industry in developing more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers! If you are looking to take on responsibility...


  • Rueil-Malmaison, France Fortrea Temps plein

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Rueil-Malmaison, France Bristol Myers Squibb Temps plein

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Rueil-Malmaison, France Alcon Temps plein

    Field Medical Advisor France At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an...

  • Senior Cra/cra Ii

    il y a 2 semaines


    Rueil-Malmaison, France Labcorp Temps plein

    Clear and confident health care decisions begin with questions. At Labcorp, we’re constantly in pursuit of answers. With unparalleled diagnostics and drug development capabilities, we accelerate innovation and provide insight to improve health and improve lives. Whether you’re a patient, provider, researcher or in the pharmaceutical industry, we’re...

  • Start-up Specialist France

    il y a 3 semaines


    Rueil-Malmaison, France Labcorp Temps plein

    Labcorp Drug Development has supported the pharmaceutical industry in developing more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers! If you are looking to take on responsibility and leverage your...


  • Rueil-Malmaison, France Novartis Temps plein

    390804BR **Gestionnaire Essai Clinique (H/F)**: France **À propos du rôle** Location: Rueil-Malmaison, Paris #LI-Hybride This person will supports SSO Study Start-Up Manager and SSO Clinical Project Manager in assigned studies during set-up and whole study lifecycle in compliance with Novartis processes, GCP/ICH and regulatory requirements. Your...

  • Start-up Specialist France

    il y a 2 semaines


    Rueil-Malmaison, France Labcorp Temps plein

    Labcorp Drug Development has supported the pharmaceutical industry in developing more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers! If you are looking to take on responsibility and leverage your...

  • Senior Biostatistician

    il y a 3 semaines


    Rueil-Malmaison, France Labcorp Temps plein

    **Job Title**: Senior Biostatistician (CDS) **Location**: Austria Belgium Bulgaria Czech Republic Estonia France Germany Greece Hungary Ireland Italy Latvia Lithuania Netherlands Poland Romania Serbia Slovakia South Africa Spain Sweden UK **Description** - ** Senior Biostatistician** required to work for Labcorp Drug Development in a...


  • Rueil-Malmaison, France Daiichi-Sankyo Europe Temps plein

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to...


  • Rueil-Malmaison, France Novartis Temps plein

    **Summary**: Set-up and execute the French RLT medical strategy aligned with Global corporate and Local company strategies, while leading a team of medical associates by embodying Novartis/Adacap values and behaviours **About the Role**: **Major Activities** (Describe the 5-7 main results of the role to be achieved ) - Involvement in all aspects of medical...

  • Global Study Manager

    Il y a 7 mois


    Rueil-Malmaison, France Labcorp Temps plein

    If you are looking for a company where you can personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view, consider working at Labcorp as a **Global Study Manager **for our Diagnostic Development Services department. In this role, you will be responsible for the successful delivery of the study...


  • Rueil-Malmaison, France Bristol-Myers Squibb Temps plein

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Rueil-Malmaison, France Labcorp Temps plein

    Labcorp, a global Laboratory Network and Clinical Research Organization, has worked on all top 50 best-selling drugs available today through its full spectrum of nonclinical and clinical laboratory solutions and data services with our clients from leading pharma and agile biotech. We are proud to be recognized as one of America's 2024 Best Large Employers by...