Study Start-up Specialist
1 mese fa
Study Start Up Specialist, IQVIA Biotech
- Italy - Homebased
- IQVIA Biotech is looking for an experienced Clinical Study Start-up professional to join our Study Start-Up Unit.
- The Study Start-up Specialists are responsible for conducting and facilitating specific start-up activities that may include site identification, feasibility, essential document collection and review, ICF customization, EC and CA submissions, preparation and negotiation of Clinical Site Contracts for ItalyReview and negotiate site regulatory documents and contracts with sites for agreement on wording and budgets. This will be done with consultation from the regulatory lead and contracts lead regionally.
- Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
- Review and provide feedback to SSU manager on site performance metrics.
- Work with regulatory team members and SSU manager to secure authorization of regulatory documents.
- Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned country.
- Responsible for the translation and co-ordination of translations for documents required for submission.
- Responsible for liaising with local CRA/CTM, Contract Specialist, and Regulatory Lead to enable a rapid clinical trial start up.
- Work with legal team members and SSU Manager to secure authorization of contracts.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- May participate in feasibility and/or site identification activities.
- Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators.
- Collects and reviews initial regulatory packets and site contracts for investigator sites.
- Assures that SSU functions interface effectively with all other key operating departments within IQVIA Biotech. Working with Clinical Operations, Project Management, Site Identification, additional SSU specialists, Regulatory and Contracts group on SSU project specific status and deliverables.
- Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
- Create, review and customization of country/site specific Informed Consent Forms (ICFs).
- Participates in business development activities to grow IQVIA Biotech’s business.
- Facilitates process improvement efforts both within the department and in cooperation with other departments.
- Qualifications-
- Fluent in reading and writing in the Italian language
- Bachelor's Degree Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
- Have extensive knowledge and understanding of submissions experience in Italy
- 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Knowledge of applicable regulatory requirements, including local regulations,, SOPs and company’s Corporate Standards.
- Understanding of regulated clinical trial environment and knowledge of drug development process.IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
-
Sso Study Start-up Country Head
2 giorni fa
Milano, Italia Novartis A tempo pieno100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine -...
-
Start Up Specialist
1 mese fa
Milano, Italia Labcorp A tempo pieno**Labcorp Drug Development** 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...
-
Regulatory & Start-up Specialist (Homebased)
3 giorni fa
Milano, Italia Novasyte A tempo pienoIQVIA 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...
-
Clinical Start Up Manager Milan
1 mese fa
Milano, Italia Resourcing Life Science A tempo pieno**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 Clinical Start up Manager office based in Milan. **Job Overview** - Leading...
-
Start Up Specialist
1 mese fa
Milano, Italia Labcorp A tempo pieno**Labcorp Drug Development** 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...
-
Study Start Up
1 settimana fa
Milano, Italia NonStop Consulting A tempo pienoAzienda internazionale presente sul mercato da oltre 20 anni, sta cercando una figura da inserire come Study Start Up/Regulatory Associate all'interno del dipartimento delle clinical operations. Tra le varie attivita', avrai il compito di fornire l'elenco dei documenti necessari per la presentazione iniziale a CA e CE per richiedere l'autorizzazione,...
-
Study Start Up Associate Ii
2 giorni fa
Milano, Italia ICON A tempo pienoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Procurement Bidding
1 mese fa
Milano, Italia Webuild A tempo pienoWebuild is hiring for the Milan Headquarters, a fix-term Procurement Bidding & Startup Specialist to work within its Global Supply Chain Department. Responsibilities include: During the bid-study phase Supporting the Bidding Support & Project Start up team to identify vendors and subcontractors to engage in the market analyses needed to define the bid...
-
Procurement Bidding
2 mesi fa
Milano, Italia Webuild A tempo pienoWebuild, nuovo nome di Salini Impregilo, è un player globale delle costruzioni specializzato nella realizzazione di grandi opere e infrastrutture complesse per la mobilità sostenibile, l’energia idroelettrica, l’acqua, i green buildings, il tunneling. Espressione di 116 anni di esperienza ingegneristica applicata in 50 paesi dei cinque continenti,...
-
Procurement Bidding
3 settimane fa
Milano, Italia Webuild A tempo pienoWebuild, nuovo nome di Salini Impregilo, è un player globale delle costruzioni specializzato nella realizzazione di grandi opere e infrastrutture complesse per la mobilità sostenibile, l’energia idroelettrica, l’acqua, i green buildings, il tunneling. Espressione di 116 anni di esperienza ingegneristica applicata in 50 paesi dei cinque continenti,...
-
Sso Contracting Specialist
1 mese fa
Milano, Italia Novartis A tempo pieno387143BR **SSO Contracting Specialist**: Italy **About the role** The SSO Contracting Specialist reports into the Study Start Up (SSU) Team Lead and is accountable for coordination, preparation, and execution of clinical study contracts in close collaboration with SSO Study Start-Up Managers, SSO Clinical Project Managers and SSO Finance Specialists in...
-
Procurement Bidding
4 settimane fa
Milano, Italia Webuild S.p.A. A tempo pienoPremi Tab per spostarti e passare al collegamento contenuto Seleziona la frequenza (in giorni) di ricezione di un avviso: Webuild, nuovo nome di Salini Impregilo, è un player globale delle costruzioni specializzato nella realizzazione di grandi opere e infrastrutture complesse per la mobilità sostenibile, l’energia idroelettrica, l’acqua, i green...
-
Sso Contracting Specialist
2 mesi fa
Milano, Italia Novartis A tempo pieno100,000+ That’s how many patients participate in our clinical trials at any given time. GCO (Global Clinical Operations) is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link...
-
Procurement Bidding
1 settimana fa
Milano, Italia Webuild S.p.A. A tempo pienoWebuild, nuovo nome di Salini Impregilo, è un player globale delle costruzioni specializzato nella realizzazione di grandi opere e infrastrutture complesse per la mobilità sostenibile, l’energia idroelettrica, l’acqua, i green buildings, il tunneling. Espressione di 116 anni di esperienza ingegneristica applicata in 50 paesi dei cinque...
-
Procurement Bidding
2 mesi fa
Milano, Italia Webuild S.p.A. A tempo pienoWebuild, nuovo nome di Salini Impregilo, è un player globale delle costruzioni specializzato nella realizzazione di grandi opere e infrastrutture complesse per la mobilità sostenibile, l’energia idroelettrica, l’acqua, i green buildings, il tunneling. Espressione di 116 anni di esperienza ingegneristica applicata in 50 paesi dei cinque...
-
Procurement Bidding
4 settimane fa
Milano, Italia Webuild S.P.A. A tempo pienoPremi Tab per spostarti e passare al collegamento contenuto Seleziona la frequenza (in giorni) di ricezione di un avviso: Webuild, nuovo nome di Salini Impregilo, è un player globale delle costruzioni specializzato nella realizzazione di grandi opere e infrastrutture complesse per la mobilità sostenibile, l'energia idroelettrica, l'acqua, i green...
-
Procurement Bidding
1 settimana fa
Milano, Italia Webuild S.P.A. A tempo pienoPremi Tab per spostarti e passare al collegamento contenuto Seleziona la frequenza (in giorni) di ricezione di un avviso: Webuild, nuovo nome di Salini Impregilo, è un player globale delle costruzioni specializzato nella realizzazione di grandi opere e infrastrutture complesse per la mobilità sostenibile, l'energia idroelettrica, l'acqua, i green...
-
Local Study Associate Director
1 mese fa
Milano, Italia AstraZeneca A tempo pieno**Local Study Associate Director** At AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve, no matter where you start with us. Welcome to MIND (Milan), one of over 400 sites here at AstraZeneca. The...
-
Study Start-up Manager
2 giorni fa
Milano, Italia Advanced Resource Managers UK A tempo pieno**Job Title**: Contract Manager for SSU **Location**: Italy-Milan **Overview**:Our client is a full-service clinical contract research organization (CRO). They provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Their mission is to accelerate the global development of safe and effective...
-
Clinical Study Administrator
3 giorni fa
Milano, Italia AstraZeneca A tempo pieno**Clinical Study Administrator OBU - Temporary 12 months** At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. Welcome to **MIND (Milan),** one of over 400 sites...
