Clinical Trial Manager

4 settimane fa

Milano, Lombardia, Italia IQVIA A tempo pieno

Clinical Trial Manager

Global or Regional Applicability: Regional

Trial Management services provide local management of a clinical trial (s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the country level for end-to-end project management from start-up through to closeout activities. Further, services will ensure the local trial team is delivering high quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the Clinical Program Leader (CPL), Global Clinical Trial Support MAO (GCTA MAO), and Global Trial Leader MAO (GTL MAO), to ensure overall study delivery at the country level.

Deliverables :


• Services rendered will adhere to applicable to sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.


• Complies with relevant training requirements.


• Prepares or contributes to high level budget estimate in response to Request for Service's followed by detailed budget proposal. Ensures overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.


• Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrolment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.


• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits. Escalates corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.


• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.


• Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study drug supply.


• Contributes to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.


• Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.


• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.


• With focus on quality, will work closely with GTL MAO, CPL to ensure CAPA is implemented for audits/inspections or any quality related issues or concerns.


• Ensures accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets.


• Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.


• May contribute as a mentor, champion, or representative of functional area in process initiatives, as required and if applicable.


• If applicable, region-specific deliverables will be specified.


• Advanced:

· Autonomy with execution of local trial management services.

· Depth of knowledge with local trial management services.

· Process leadership.

Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.

Interfaces – Primary/Other:


• Primary interfaces: Provider Functional Manager, sponsor Point of Contact, Clinical Program Leader (CPL), Clinical Operations Head (COH), Global Trial Leader MAO (GTL MAO), Global Clinical Trial Support MAO (GCTA MAO), Site Manager (SM), GD functions, GCO country teams, Country Medical Affairs teams, Project Owners and other sponsor enterprise sectors applicable for study conduct.


• Other interfaces: Regional Quality and Compliance Manager/Specialist, Contracts and Grants Managers, Local Drug Safety Officer (where required), Central Study Team, Investigators, Trial personnel including study coordinators, pharmacists, etc., external vendor representatives and Ethics Committee and others, as required.

Education and Experience requirements:


• BA/BS degree.


• Degree in a health or science related field.


• Minimum of 5 years of clinical research experience in the pharmaceutical industry or CRO.


• Specific therapeutic area experience may be required depending on the position.


• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.


• Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.


• Excellent decision-making and string financial management skills.


• Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.


• Flexibility and ability to manage study teams in a virtual environment

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

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q2 Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled


  • Clinical Trial Ambassador

    7 giorni fa

    Milano, Lombardia, Italia Syneos Health Clinical A tempo pieno

    OverviewThe Clinical Trial Ambassador will establish, cultivate, and maintain scientific relationships with investigators and study coordinators to support enrollment while developing a strong understanding of clinical practice as it relates to areas of interest. This position interacts with various internal and external stakeholders, with a focus on...

  • Junior Clinical Trial Manager

    7 giorni fa

    Milano, Lombardia, Italia BI Italia Spa A tempo pieno

    THE POSITION:The Junior Clinical Trial Manager (JCTM) is a key position in local on the delivery of Boehringer Ingelheim's pipeline and accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at local level.**For this position we offer a one year fixed term contract with external agency...

  • Clinical Trial Manager

    7 giorni fa

    Milano, Lombardia, Italia 150 Icr Italy - Itl A tempo pieno

    Clinical Trial Manager (local) page is loaded Clinical Trial Manager (local) Apply locations Italy, Milan Italy, Rome time type Full time posted on Posted 5 Days Ago job requisition id JR120825 ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced...

  • Clinical Trial Manager

    7 giorni fa

    Milano, Lombardia, Italia JSB SOLUTIONS S.R.L A tempo pieno

    **JSB Solutions**, azienda di consulenza nata nel 2009 con 3 sedi in Italia (Firenze, Parma e Milano) è alla ricerca di un**Clinical Trial Manager**:- (JSB.SRF _ da inserire nel nostro team di consulenti in area**CRO **per la nostra sede di**Milano**.**Clinical Project Management di almeno 3 anni in contesti farmaceutici** e sarà inserito nel**team di...

  • Clinical Trial Manager

    7 giorni fa

    Milano, Lombardia, Italia Icon A tempo pieno

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...

  • Sso Clinical Trial Associate

    7 giorni fa

    Milano, Lombardia, Italia Novartis A tempo pieno

    100,000+ 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 between...

  • Clinical Trial Assistant

    7 giorni fa

    Milano, Lombardia, Italia Novasyte A tempo pieno

    Clinical Trials Assistant - Multisponsor - Milano (Hybrid)Job Overview:Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.Essential Functions: Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU)...

  • Clinical Trial Manager Emea

    7 giorni fa

    Milano, Lombardia, Italia Boston Scientific Corporation A tempo pieno

    Work mode:Remote in CountryOnsite Location(s):Milan, MI, ITAdditional Locations: Italy-Milan; France-Île-de-France; Germany-Düsseldorf; Poland-Warsaw; Spain-Madrid; United Kingdom-Hemel HempsteadDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all...

  • Senior Clinical Trials Manager

    1 ora fa

    Milano, Lombardia, Italia Quanta part of QCS Staffing A tempo pieno

    Senior Clinical Trials Manager - Pharmaceuticals - Various EU LocationsWe have an exciting opportunity with a North Carolina based client who's focus on the research, development, and commercialization of products helps patients who haven't yet received necessary care.You would contribute to their portfolio of life changing products as a Senior Clinical...

  • Global Clinical Trials Manager

    7 giorni fa

    Milano, Lombardia, Italia Tn Italy A tempo pieno

    col-wideJob Description:Global Clinical Trials Manager PharmaceuticalsVarious EU LocationsWe have an exciting opportunity with a North Carolina based client who's focus on the research, development, and commercialisation of products helps patients who haven't yet received necessary care. You would contribute to their portfolio of life changing products as a...

  • Study Coordinator Clinical Trial Office

    7 giorni fa

    Milano, Lombardia, Italia Istituto Europeo di Oncologia A tempo pieno

    L'Istituto Europeo di Oncologia, IRCCS con sede in Milano ricerca di uno Study Coordinator con esperienza di Start Up da inserire nel Clinical Trial Office.La figura, che riporta al responsabile del servizio dovrà essere di supporto per l'attivazione degli studi clinici sia spontanei che promossi da enti terzi (aziende farmaceutiche e gruppi scientifici)...

  • Local Trial Manager

    7 giorni fa

    Milano, Lombardia, Italia Amgen Sa A tempo pieno

    If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10...

  • Impiegato/a - Segreteria Clinical Trial Center

    7 giorni fa

    Milano, Lombardia, Italia Ospedale San Raffaele srl A tempo pieno

    L'IRCCS Ospedale San Raffaele, struttura clinica-scientifica-universitaria di rilievo internazionale e di alta specializzazione per diverse importanti patologie, sta ricercando per la Segreteria del Clinical Trial Center, la risorsa si occuperà di gestire le pratiche segretariali a supporto della gestione degli studi clinici.**Attività principali**:Nello...

  • Local Trial Manager

    3 settimane fa

    Milano, Lombardia, Italia Amgen A tempo pieno

    If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10...

  • Clinical Study Specialist

    7 giorni fa

    Milano, Lombardia, Italia Confidenziale A tempo pieno

    Clinical Study SpecialistNell'ambito della struttura di Medical Affairs and Clinical Operations, stiamo cercando un Clinical Study Specialist (CSS) che verrà inserito nel gruppo di Study Management a diretto riporto del CSS Manager ed avrà la responsabilità di collaborare con i Clinical Study Manager (CSM) nelle attività di tipo progettuale ed operativo,...

  • Snr Clinical Research Associate

    7 giorni fa

    Milano, Lombardia, Italia Worldwide Clinical Trials A tempo pieno

    Requisition Number6939Employment Type:ContractorWho we areWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company's scientific heritage, our...

  • Manager, Site Management Franchise Lead

    7 giorni fa

    Milano, Lombardia, Italia Worldwide Clinical Trials A tempo pieno

    Requisition Number6163Employment Type:RegularWho we areWe're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.We are...

  • Clinical Compliance Specialist R&d

    7 giorni fa

    Milano, Lombardia, Italia Novasyte A tempo pieno

    Our client, Chiesi Farmaceutici - one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of a Clinical Compliance Specialist R&D who can join an exciting working environment in a dynamic and...

  • Sr. Site Manager

    7 giorni fa

    Milano, Lombardia, Italia Johnson and Johnson A tempo pieno

    We are looking for a driven Senior Site Manager to serve as the primary contact point between the Sponsor and the Investigational Site for assigned clinical trials (phase 1-4) within the a signed Therapeutic Area that will be decided based on workload distribution.As Senior Site Manager, you have to ensure inspection readiness and compliance with the...

  • Sr. Site Manager

    7 giorni fa

    Milano, Lombardia, Italia Johnson And Johnson A tempo pieno

    We are looking for a driven Senior Site Manager to serve as the primary contact point between the Sponsor and the Investigational Site for assigned clinical trials (phase 1-4) within the a ssigned Therapeutic Area that will be decided based on workload distribution .As Senior Site Manager, you have to ensure inspection readiness and compliance with the...