Start Up

1 mese fa

Milano, Italia Mil Fortrea Clinical Development Ltd Filiale Italiana A tempo pieno

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.
Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.This role is for upcoming future opportunities they may arise at Fortrea 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 and objectives especially during study start-up.
The ability to indirectly influence investigators, vendors, external partners, and country managers to deliver these commitments is a must.
This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country-based regulations, laws and procedures with minimal support from the client management.
Requires skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.
Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.Summary of Responsibilities:• FINANCIAL (as applicable):o Assistance with the ownership of country and site budgets.o Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.o Oversight and tracking of clinical research-related payments.o Payment reconciliation at study close-out.
•• COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS (as applicable):o Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.o Development of local language materials including local language Informed Consents and translations.o Works in partnership with IRB/IEC and Regulatory Authority in submission and approval related interactions for assigned protocols.• MANAGEMENT & QUALITY OVERSIGHT:o Responsible for managing country deliverables, timelines, and results for assigned protocols to meet country commitments.o Contributes to the development of local SOPs.• COLLABORATION:o Works in close collaboration internally with Clinical country operations (CRD, CRM, CTC, CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.o Collaborates closely with Regional Operations to align country timelines for assigned protocols.
Provides support and oversight to local vendors as applicable.• LOCAL PROCESS OVERSIGHT: (as applicable):o Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
o Enters and updates country information in clinical, regulatory, safety and finance systems.• And all other duties as needed or assignedQualifications (Minimum Required): • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.• In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered.• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.• Thorough understanding of the drug development process • Fluent in local office language and in English, both written and verbalExperience Minimum ( required)• Good organizational and time management skills• Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.• Excellent communication skills, oral and written.• Self-motivation with the ability to work under pressure to meet deadlines.
Works well independently and in a team environment.• Detail and process oriented• Positive attitude and approach• Interact with internal and external customers with a high degree of professionalism and discretion.• Multi-tasking capability.• Good computer skills with good working knowledge of a range of computer packages• Ability to lead and develop junior staff.• Flexible and adaptable to a developing work environment• Minimum of four-six (4-6) years of clinical research experienceFortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.
Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

  • Clinical Start Up Manager Milan

    6 mesi 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 cross-functional project...

  • Study Start Up Manager

    7 giorni fa

    Milano, Italia Ergomed A tempo pieno

    Company Description Ergomed is a rapidly growing global clinical research company. We perform clinical trials for rare and complex diseases. Ergomed Plc is a public company on the London stock exchange. The company boasted 40% growth in its revenues in its last report. This success is due to the hard work of our highly skilled employees and our subsequent...

  • Accountant - Start Up Innovativa

    7 mesi fa

    Milano, Italia HAYS A tempo pieno

    Contabilità | Bilancio | Start Up | Ingegneria | Telecomunicazioni | Energy **La tua nuova azienda** Il nostro cliente è una start up leader nello sviluppo di soluzioni all'avanguardia nel campo delle infrastrutture, dei sistemi energetici e delle telecomunicazioni. Con diverse società di successo già lanciate, si distingue per un approccio giovane,...

  • Start-up Account

    15 ore fa

    Milano, Italia Page Personnel Italia A tempo pieno

    La figura entrerà con il ruolo di Start-up Account e darà il suo contributo con le seguenti attività: - Gestione del portafoglio clienti assegnato, attraverso attività di consulenza diretta,con l'obiettivo di individuare opportunità di valore per i clienti; - Affiancamento tecnico al business developer per favorire la chiusura dei contratti; - Costante...

  • Study Start-Up Team Lead

    1 giorno fa

    Milano, Italia Novartis Farmacéutica A tempo pieno

    The Study Start-up Team Lead (SSU Team Lead) is accountable for the governance and oversight of a country study start-up managers team.We are seeking a dynamic and experienced SSO Study Start-Up Team Lead to join our passionate team.This pivotal position reports directly into the Study Start Up (SSU) Country Head and is responsible to lead, mentor and...

  • Study Start Up Manager

    4 giorni fa

    Milano, Italia Ergomed A tempo pieno

    Company DescriptionErgomed is a rapidly growing global clinical research company.We perform clinical trials for rare and complex diseases.Ergomed Plc is a public company on the London stock exchange.The company boasted 40% growth in its revenues in its last report.This success is due to the hard work of our highly skilled employees and our subsequent...

  • Accountant - Start Up Innovativa

    3 settimane fa

    Milano, Italia Hays A tempo pieno

    Contabilità | Bilancio | Start Up | Ingegneria | Telecomunicazioni | Energy**La tua nuova azienda**Il nostro cliente è una start up leader nello sviluppo di soluzioni all'avanguardia nel campo delle infrastrutture, dei sistemi energetici e delle telecomunicazioni.Con diverse società di successo già lanciate, si distingue per un approccio giovane,...

  • Oncology Study Start-up Manager

    1 mese fa

    Milano, Italia AstraZeneca A tempo pieno

    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 site provides a collaborative environment...

  • Study Start-Up Team Lead

    2 settimane fa

    Milano, Italia Healthcare Businesswomen’S Association A tempo pieno

    Job Description Summary The Study Start-up Team Lead (SSU Team Lead) is accountable for the governance and oversight of a country study start-up managers team.We are seeking a dynamic and experienced SSO Study Start-Up Team Lead to join our passionate team.This pivotal position reports directly into the Study Start Up (SSU) Country Head and is responsible to...

  • Oncology Study Start-Up Manager

    4 giorni fa

    Milano, Italia Astrazeneca A tempo pieno

    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 site provides a collaborative environment where...

  • Biogas Plant Start-Up Technician

    3 settimane fa

    Milano, Italia Biogas Community A tempo pieno

    Language(s)Added onFriday, December 13th 2024Deadline to apply2025-02-02Job DescriptionPrepare, supervise and monitor all aspects of plant start-up.ResponsibilitiesPreparation for unit start-up activity: Collection of site documents, communication to the plant manager, reporting of any difficulties or problems encountered on the plant, etc.Commissioning...

  • Regulatory & Start-up Specialist (Homebased)

    7 mesi fa

    Milano, Italia Novasyte A tempo pieno

    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...

  • Regulatory & Start-Up Specialist (Homebased)

    2 settimane fa

    Milano, Italia Novasyte A tempo pieno

    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...

  • Procurement Bidding

    7 mesi fa

    Milano, Italia Webuild A tempo pieno

    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 buildings, il tunneling. Espressione di 116 anni di esperienza ingegneristica applicata in 50 paesi dei cinque continenti,...

  • Procurement Bidding

    7 mesi fa

    Milano, Italia Webuild A tempo pieno

    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 buildings, il tunneling. Espressione di 116 anni di esperienza ingegneristica applicata in 50 paesi dei cinque continenti,...

  • Procurement Bidding

    3 mesi fa

    Milano, Italia Webuild A tempo pieno

    **Data**:7 ott 2024 **Location**: Milano, Italia **Società**:Webuild S.p.A. 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 buildings, il tunneling. Espressione di 117...

  • Procurement Bidding

    3 giorni fa

    Milano, Italia Webuild A tempo pieno

    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 buildings, il tunneling.Espressione di 116 anni di esperienza ingegneristica applicata in 50 paesi dei cinque continenti, grazie al...

  • Procurement Bidding

    6 giorni fa

    Milano, Italia Webuild A tempo pieno

    **Data**:7 ott 2024**Location**: Milano, Italia**Società**:Webuild S.p.A.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 buildings, il tunneling.Espressione di 117 anni di...

  • Procurement Bidding

    2 settimane fa

    Milano, Italia Webuild A tempo pieno

    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 buildings, il tunneling.Espressione di 117 anni di esperienza ingegneristica applicata in 50 paesi dei cinque continenti, grazie al...

  • Procurement Bidding

    3 settimane fa

    Milano, Italia Webuild A tempo pieno

    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 buildings, il tunneling.Espressione di 117 anni di esperienza ingegneristica applicata in 50 paesi dei cinque continenti, grazie al...