Clinical Research Manager

2 settimane fa

Milan, Italia Pharmiweb 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. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

The Clinical Research 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 in compliance with ICH GCP and country regulations.

Summary of Responsibilities:
• PERFORMANCE: Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. 30%
• MANAGEMENT: POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated). 20%
• QUALITY OVERSIGHT: Responsible for quality and compliance in assigned protocols in country.
Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. Oversees associate CRMs assigned to the Client and work on training needs in collaboration with functional vendor. 20%
• EXTERNAL CUSTOMER FACING: Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols. 20%
• INTERNAL COLLABORATION & STRATEGY: Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. 10%
• All other duties as needed or assigned.
Qualifications (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.
• In lieu of the above requirement, candidates with 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 verbal.

Fortrea 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. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

  • Senior Clinical Research Associate

    4 settimane fa

    Milan, Italia Worldwide Clinical Trials A tempo pieno

    Requisition Number7552Employment Type:Regular Who we are Worldwide 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...

  • Senior Clinical Research Associate

    4 settimane fa

    Milan, Italia Worldwide Clinical Trials A tempo pieno

    Requisition Number7795Employment Type:Regular Who we are Worldwide 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...

  • Senior Clinical Research Associate

    2 giorni fa

    Milan, Italia Worldwide Clinical Trials, LLC A tempo pieno

    Who 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 dedicated therapeutic focus on...

  • Clinical Research Associate II

    3 giorni fa

    Milan, Italia PSI CRO A tempo pieno

    Job DescriptionAs a Clinical Research Associate at PSI Italy you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.Hybrid working arrangement in Milan area or homebased in other regions of ItalyResponsibilities:Conduct and report all types of...

  • Clinical Research Associate II

    3 giorni fa

    Milan, Italia PSI A tempo pieno

    Job Description As a  Clinical Research Associate  at PSI Italy you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. Hybrid working arrangement in Milan area or homebased in other regions of Italy Responsibilities: Conduct and...

  • Clinical Research Associate – Italy

    4 settimane fa

    Milan, Italia Excelya A tempo pieno

    Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas. We take a one-team approach to work: our shared success is the result of collaboration at every stage of...

  • Clinical Research Associate, Site Management

    1 settimana fa

    Milan, Italia IQVIA A tempo pieno

    Job Overview Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. Essential Functions • Complete appropriate therapeutic, protocol and clinical...

  • Clinical Research Associate II

    2 settimane fa

    Milan, Italia Pharmiweb A tempo pieno

    Job Overview: As a Senior CRA specializing in ophthalmology, you will play a crucial role in the planning, implementation, monitoring, and management of clinical trials related to ophthalmic drugs, devices, or therapies. You will ensure that clinical trials are conducted in accordance with applicable regulatory requirements, protocols, and standard operating...

  • Experienced Clinical Research Associate, Site Management

    1 settimana fa

    Milan, Italia IQVIA A tempo pieno

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Clinical Research Associate II

    4 settimane fa

    Milan, Italia Fortrea 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. With over 19,000 staff...

  • Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA

    2 settimane fa

    Milan, Italia IQVIA A tempo pieno

    Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...

  • Clinical Supply Chain Manager.

    1 settimana fa

    Milan, Italia PSI A tempo pieno

    Job Description In this role, you will undertake activities to assess, plan and set up trial supply schemes for assigned projects and manage vendors involved in clinical supplies and interactive response technology. Office-based or Home-based You will: Analyze clinical trial protocols and translate requirements to establish an efficient supply...

  • Clinical Supply Chain Manager

    1 settimana fa

    Milan, Italia PSI CRO A tempo pieno

    Job DescriptionIn this role, you will undertake activities to assess, plan and set up trial supply schemes for assigned projects and manage vendors involved in clinical supplies and interactive response technology.Office-based or Home-basedYou will:Analyze clinical trial protocols and translate requirements to establish an efficient supply chain solution for...

  • Senior Field Clinical Specialist

    4 settimane fa

    Milan, Italia Abbott A tempo pieno

    About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in...

  • Principal Statistical Programmer

    1 mese fa

    Milan, Italia Worldwide Clinical Trials A tempo pieno

    Requisition Number6390Employment Type:Regular Who we are Worldwide 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...

  • Research Team Manager

    2 giorni fa

    Milan, Italia BlogMeter A tempo pieno

    Per il nostro dipartimento di Research & Insights cerchiamo un/unaResearch Team Manager. La figura ricercata ha passione per le ricerche di mercato (principalmente qualitative) ed è appassionata di social network, curiosa di osservare e comprendere i nuovi trend emergenti di questo settore. La figura selezionata si occuperà di: gestire il team di analisti...

  • Sensory Research Manager

    4 settimane fa

    Milan, Italia Eurofins A tempo pieno

    Job Description Supporting and consulting of our clients in all aspects of sensory and consumer research Preparation of proposals (test design, price calculation) Project management and coordination. Statistical analysis of raw data and data visualization of results/reporting. Presentation of results to the clients. Building long-term client...

  • Principal - Integrated Research

    4 settimane fa

    Milan, Italia IQVIA A tempo pieno

    Job Family: Consulting Services Location: [EU-Wide] Real World Commercial Solutions to Create a Healthier World In RWCS we’re passionate about improving the life sciences ecosystem and making decisions that accelerate innovation for a healthier world. Every day our team develops evidence-based strategies that are used in published research,...

  • RESEARCH MANAGER

    2 giorni fa

    Milan, Italia PRAXI A tempo pieno

    RESEARCH MANAGER/PROGRAM MANAGER/GRANT OFFICER Role Within the Foundation, reporting directly to the General Director, the role will have the objective of managing and monitoring the execution of strategic, organizational, and governance support services, coordinating a small (but with the possibility of expansion) team of resources.Activity The sought-after...

  • RESEARCH MANAGER

    4 settimane fa

    Milan, Italia PRAXI A tempo pieno

    RESEARCH MANAGER/PROGRAM MANAGER/GRANT OFFICER Role Within the Foundation, reporting directly to the General Director, the role will have the objective of managing and monitoring the execution of strategic, organizational and governance support services, coordinating a small (but with the possibility of expansion) team of resources . Activity :...