Study Start Up Specialist

il y a 1 semaine

Paris, France Excelya Temps plein

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service, functional service provider and consulting - allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

**What we offer**:
Within the SSU team, and in collaboration with the other regulatory managers and clinical trial project leaders you will be responsible for:

- Constitute, submit, and follow up on clinical trial opinion and authorization request files with the ANSM and the Personal Protection Committees (CPP)
- Participate in meetings of the EC support team and project teams for the coordination of CPP and ANSM activities
- Report to global and local teams, and update support tracking software

**Minimum Requirements**:

- Extensive experience in a pharmaceutical laboratory preparing and submitting dossiers to CPP and ANSM for interventional research,
- In-depth knowledge of the Experimental Drug File for the ANSM file
- Knowledge of the regulations related to EC and corresponding systems (EUDRALINK),
- Team spirit, rigor, multi-project work.
- Fluent English

**Résumé**:

- Type of job:
Full-time
- Location:
Paris Area
- Capability:
Clinical Research

**Contact**:

- **Clara Rousselet-Blanc**
Talent Manager

  • (Senior) Study Start-up Specialist

    il y a 10 heures

    Paris, France Precision Medicine Group Temps plein

    Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...

  • Study Start Up Specialist

    il y a 10 heures

    Paris 1er, France TempoPHARMA Temps plein

    Nous recrutons sur Paris un Study Start Up Specialist H/F. Vous aurez pour principales missions: - Préparation et relecture des documents d’études (synopsis, brochure investigateur ) - Soumissions réglementaires des demandes d’autorisation d’essai clinique et amendements - Etude de faisabilité et mise en place des études cliniques - Formation...

  • Senior Start Up Specialist Paris

    il y a 2 semaines

    Paris, France Resourcing Life Science Temps plein

    **Company Description** Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Start up Specialist office based in Paris. **Job Overview** - Responsible for CA &...

  • Regulatory & Start Up Specialist, French Speaker

    il y a 7 jours

    Paris, France Novasyte Temps plein

    IQVIA MedTech Clinical Solutions, specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products.- IQVIA MedTech’s focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and...

  • Country Study Operations Manager

    il y a 1 semaine

    Paris, France Parexel Temps plein

    Parexel are currently recruiting for an experienced Local/Country focused Study Operations Manager in France. In this role, the Country Study Operations Manager will be responsible for study and country level activities from start up through conduct and study close. The Country Study Operations Manager has responsibility for study management aspects of...

  • Manager, Site Start Up

    il y a 2 semaines

    Paris, France Precision Medicine Group Temps plein

    **Position Summary**: Manages and oversees the day-to-day activities Site Start-up (SSU) personnel in accordance with Standard Operating Procedures (SOPs), regulatory directives, and study specific plans with an emphasis on effective resourcing and development of personnel. Provides oversight and leading activities for site start up project delivery;...

  • Start-up Manager

    il y a 2 semaines

    Paris, France GIP Genopole Temps plein

    Vous serez en charge de la responsabilité d’un portefeuille de start-Up ainsi que du fonctionnement du programme d’accélération de start-Ip, Gene.io au sein du département Emergence et sous la responsabilité de son Directeur. **Vos principales missions seront les suivantes**: 1. Responsabilité d’un portefeuille de start-Up en phase...

  • Momentum (Start-up) - CEO

    il y a 11 heures

    Paris, France EMERTON GROUP Temps plein

    KAUKANA VENTURES Kaukana Ventures is a **start-up studio** with deep expertise in AI and Data Science that focuses on four major areas : AI, Agriculture, Future of Work and FinTech Web3. We anchor our studio on very robust technology foundations. Kaukana Venture incubates and ramps-up new ventures and products on promising topics. Our best-in-class...

  • Regulatory & Start Up Specialist, Biotech, France

    il y a 7 jours

    Paris, Île-de-France IQVIA Temps plein

    Regulatory & Start-Up Specialist 1IQVIA BiotechFranceHomebasedIQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative...

  • Everykid Recrute CEO Pour Start-up en Pleine

    il y a 2 semaines

    Paris, France people&baby Temps plein

    Fort de son développement le groupe a créé la première centrale d'achats dédiée à la Petite Enfance, Everykid. Une boutique en ligne capable de répondre aux besoins sur tous les secteurs. Une véritable réussite qui a conduit Everykid à développer de nouvelles marques de produit. De l'alimentaire aux jouets, de la mode à l'entretien, nos 5000...