Regulatory and Start Up Specialist 2
4 settimane fa
Job Overview 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. At least 3 years' experience with submissions. Italian and English fluent. Essential Functions Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. Prepare site regulatory documents, reviewing for completeness and accuracy. Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. Review and provide feedback to management on site performance metrics. Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed. Inform team members of completion of regulatory and contractual documents for individual sites. Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines. Provide local expertise to SAMs and project team during initial and on-going project timeline planning. Perform quality control of documents provided by sites. May have direct contact with sponsors on specific initiatives. Qualifications 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. 1 year experience in a leadership capacity. Equivalent combination of education, training and experience. In-depth knowledge of clinical systems, procedures, and corporate standards. Ability to manage multiple projects. Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines. 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. Ability to establish and maintain effective working relationships with coworkers, managers and clients. 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 #J-18808-Ljbffr
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Regulatory And Start Up Specialist
4 settimane fa
Milano, Italia Iqvia Argentina A tempo pienoJob Overview 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. At least 3 years' experience with submissions. Italian...
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Regulatory and Start Up Specialist 2
4 settimane fa
Milano, Italia IQVIA Argentina A tempo pienoJob Overview 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. At least 3 years' experience with submissions....
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Regulatory and Start Up Specialist
1 mese fa
Milano, Italia IQVIA A tempo pieno**Job Overview** 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** - Under general supervision,...
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Study Start-up Specialist
4 settimane fa
Milano, Italia Novasyte A tempo pienoStudy 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...
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Study Start-up Specialist
1 giorno fa
Milano, Italia Novasyte A tempo pienoStudy 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...
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Regulatory and Start Up Specialist
1 mese fa
Milano, Italia Novasyte A tempo pienoJob Overview 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. _Hungarian and English Fluent._ Essential Functions -...
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Regulatory and Start Up Specialist
1 mese fa
Milano, Italia Novasyte A tempo pienoJob Overview 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. Italian and English Fluent. Essential Functions - Under...
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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...
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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...
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Milano, Italia Novasyte A tempo pienoJob Overview Our teams are growing! - We are looking for a Clinical Operation Manager | Regulatory and Start Up Manager to work fully dedicated to one of our biggest sponsor. - This person will direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including...
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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...
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Associate Local Start Up Manager
1 mese fa
Milano, Italia Labcorp A tempo pienoThe Associate Local Start Up Manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client. The position has a significant impact on how a country can deliver country-specific trial commitments...
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Study Start Up
16 ore 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,...
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Milano, Italia AstraZeneca A tempo pieno**Regulatory Affairs and Quality Specialist Location**: Alexion Pharma Italy Milan Reports To: Director Regulatory Affairs and Quality ItalyDate: June 1st 2023 This is what you will do: The RAQ Specialist will work under the responsibility of the RAQ Director Italy. They will provide support to the local regulatory and quality activities managed by the RAQ...
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Clinical Start Up Manager Milan
4 settimane 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...
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Regulatory And Corporate Affairs Specialist
6 giorni fa
Milano, Italia Hamilton Court Fx A tempo pienoAbout us Hamilton Court FX is a boutique founded in 2011 in London and is now positioned among the fastest-growing companies in the sector. It has been ranked in The Sunday Times Virgin Atlantic Fast Track 100 as one of Britain's private companies with the fastest-growing sales. In 2020, motivated by a strong local growth in the United Kingdom, it took the...
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Regulatory And Corporate Affairs Specialist
2 giorni fa
Milano, Italia Hamilton Court Fx A tempo pienoAbout us Hamilton Court FX is a boutique founded in 2011 in London and is now positioned among the fastest-growing companies in the sector. It has been ranked in The Sunday Times Virgin Atlantic Fast Track 100 as one of Britain's private companies with the fastest-growing sales. In 2020, motivated by a strong local growth in the United Kingdom, it took the...
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Regulatory and Corporate Affairs Specialist
7 giorni fa
Milano, Italia Hamilton Court FX A tempo pieno**About us**: Hamilton Court FX is a boutique founded in 2011 in London and is now positioned among the fastest-growing companies in the sector. It has been ranked in The Sunday Times Virgin Atlantic Fast Track 100 as one of Britain’s private companies with the fastest-growing sales. In 2020, motivated by a strong local growth in the United Kingdom, it...
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Logistics Start-Up Founder
2 giorni fa
Milano, Italia Ewor Gmbh A tempo pienoLogistics Start-up Founder - Product Owner, Manager, and Head of Product at your own start-up (100 % remote) (m/f/d) Milan, Italy (hybrid) Freelance Other With unicorn founders like Paul Müller as part of the founders and team, we help outstanding talents and serial entrepreneurs build and scale their ventures. Our three founders - Daniel , Alex ,...
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Logistics Start-Up Founder
2 giorni fa
Milano, Italia Ewor Gmbh A tempo pienoLogistics Start-up Founder - Product Owner, Manager, and Head of Product at your own start-up (100 % remote) (m/f/d) Milan, Italy (hybrid) Freelance Other With unicorn founders like Paul Müller as part of the founders and team, we help outstanding talents and serial entrepreneurs build and scale their ventures. Our three founders - Daniel , Alex ,...