20 annunci per il ruolo di country associate submissions representative, italy, iqvia biotech - modena, emi (recruiting in corso)

Country Associate Submissions Representative, Italy, IQVIA Biotech
IQVIA —Modena, Emilia-Romagna
- 33.000 € - 61.400 € all'anno
- Part-time
- Remoto
- Manutenzione
7 giorni
Materials Planner
Ferrari —Maranello, Emilia-Romagna
- 50.000 € - 55.000 € all'anno
- Remoto
- Gestionale
- Ingegneria
- Sistemi ERP
13 giorni
Project Leader Automotive (Italy)
Quest Global —Maranello, Emilia-Romagna
- 50.000 € - 65.000 € all'anno
- Tempo pieno
- Remoto
- Gestionale
- Project management
- Leadership
Candidatura rapida
Product Specialist
CNH Industrial —Modena, Emilia-Romagna
- 44.200 € - 52.000 € all'anno
- Tempo pieno
- Gestionale
- Ingegneria
- Laurea magistrale
- Rimborso tasse scolastiche
- Congedo parentale
11 giorni
Product Specialist
Case New Holland Industrial —Modena, Emilia-Romagna
- 44.200 € - 52.000 € all'anno
- Tempo pieno
- Gestionale
- Ingegneria
- Laurea magistrale
- Rimborso tasse scolastiche
- Congedo parentale
11 giorni
Product Marketing Specialist
CNH Industrial —Modena, Emilia-Romagna
- 40.000 € all'anno
- Tempo pieno
8 giorni
Senior project manager
Coesia —Fiorano Modenese, Emilia-Romagna
- Da 64.000 € all'anno
- Gestionale
- Project management
- Miglioramento continuo
Candidatura rapida
Country/Market Brand Leader
CNH Industrial —Modena, Emilia-Romagna
- Tempo pieno
Application Senior Specialist
CNH Industrial —Modena, Emilia-Romagna
- Tempo pieno
- Gestionale
- Ingegneria
- Competenze analitiche
Driveline&Fluid Power Lead Test Engineer
Case New Holland Industrial —Modena, Emilia-Romagna
- 40.000 € - 52.000 € all'anno
- Tempo pieno
- Microsoft Word
- Microsoft Excel
- Gestionale
- Rimborso tasse scolastiche
- Congedo parentale
5 giorni
Senior Linux System Administrator- Emilia Romagna
Do IT Now Italy —Maranello, Emilia-Romagna
- 30.000 € - 40.000 € all'anno
- Tempo pieno
- Remoto
- Inglese
- Microsoft Office
- Database
Candidatura rapida
Driveline&Fluid Power Lead Test Engineer
CNH Industrial —Modena, Emilia-Romagna
- 40.000 € - 52.000 € all'anno
- Tempo pieno
- Microsoft Word
- Microsoft Excel
- Gestionale
- Rimborso tasse scolastiche
- Congedo parentale
5 giorni
Project Manager
System Logistics S.p.A. —Fiorano Modenese, Emilia-Romagna
- 45.000 € - 55.000 € all'anno
- Tempo pieno
- Spagnolo
- Gestionale
- PMP
Site Manager - Sassuolo
Apleona Italy S.p.A. —Modena, Emilia-Romagna
- Straordinari
- Manutenzione
- Maturità
- Time management
Candidatura rapida
Project Leader - Product Development Hydraulic
Segula Technologies —Modena, Emilia-Romagna
- 38.000 € - 45.000 € all'anno
- Tempo pieno
- Gestionale
- Inglese
- Laurea magistrale
Candidatura rapida
Field Service Engineer - Rubiera (RE)
Endress+Hauser Italy —Rubiera, Emilia-Romagna
- 30.000 € - 40.000 € all'anno
- Tempo pieno
- Inglese
- Assicurazione sanitaria
Tecnico/a Commerciale Interno - Modena
Sonepar Italia —Modena, Emilia-Romagna
- Capacità di comunicazione
- Negoziazione
Graduate Area/Shift Manager Emilia-Romagna
Amazon Italia Transport Srl —Spilamberto, Emilia-Romagna
- 38.200 € all'anno
- Tempo pieno
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Partecipazione azionaria
System Engineer - Autonomous & Intelligent Systems
TMC —Modena, Emilia-Romagna
- Da 32.000 € all'anno
- Ingegneria
- Partecipazione agli utili
16 ore
Especialista sénior aplicaciones
CNH Industrial —Modena, Emilia-Romagna
- Gestionale
- Ingegneria
- Competenze analitiche

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Country Associate Submissions Representative, Italy, IQVIA Biotech

IQVIA -
Modena, Emilia-Romagna

Candidati adesso

Dettagli della posizione

Part-time
33.000 € - 61.400 € all'anno
7 giorni fa

Qualifiche

Manutenzione
Google Cloud Platform

Descrizione completa della posizione

Country Associate Submissions Representative (Regulatory & Start-Up Specialist)

Homebased

Italy

IQVIA 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 treatments to patients faster.

Job Overview

Position requires EU CTR experience for Italy, local language proficiency, and knowledge of national requirements. Certain submission tasks mandate a local address. Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions

As Regulatory & Start-Up Specialist, you will work and lead complex projects under general supervision, serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary.

You will also ensure adherence to standard operating procedures (SOPs), Work Instructions, quality of designated deliverables and project timelines.

You will prepare submission documents and submit to regulatory bodies.

You will perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions, along with distributing completed documents to sites and internal project team members.

You will also prepare site documents and review for completeness and accuracy, along with reviewing, tracking, and following up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form, and Investigator Pack release documents, in line with project timelines.

Coupled with informing team members of completion of feasibility, site ID, regulatory and contractual documents for individual sites, and providing local expertise to SAMs and project team during initial and on-going project timeline planning. Along with performing quality control of documents provided by sites.

You may also act as an SME on specific subjects, mentor junior CSAs, and have a sponsor-facing role.

Qualifications & Skills

B Sc degree in Health Sciences or related field
1 to 3 years' relevant clinical research experience
Experience in EUCTR and CTIS submission procedures, feasibility and Country Inform Consent adaptation for Italy region very beneficial
Experience in Site Contract negotiations with sites in Italy very beneficial
Experience in medical device submissions is beneficial
In-depth knowledge of clinical systems, procedures, and corporate standards
Good communication skills in local language
Effective communication, organizational, and interpersonal skills
Ability to work independently and to effectively prioritize tasks
Ability to manage multiple projects
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
Understanding of regulated clinical trial environment and knowledge of drug development process

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is €33,000.00 - €61,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Candidati adesso

Perfeziona la tua ricerca

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Especialista sénior aplicaciones

Voglio ricevere gli ultimi avvisi Job Alert per il ruolo di country associate submissions representative, italy, iqvia biotech nella seguente località: modena, emi

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