311 Posti di lavoro per Clinical trials in Lombardia

Experienced Clinical Research Associate (Cra)

Lombardia, Lombardia Buscojobs

Inserito 16 giorni fa

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Descrizione Del Lavoro

Clinical Research Associate, Site Management - Italy

EUR 30.000 - 50.000

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 research training to perform job duties.
• Gain experience in study procedures by working with experienced clinical staff.
• Under close supervision, perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.
• Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
• Under close supervision, ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements.
• Under close supervision may support start-up phase.
• Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas for improving site recruitment plan in line with project needs to enhance predictability. Assist in tracking subject site recruitment progress.

Qualifications
• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree.

• In possess of the local ministerial decree as per Italian requirements.

• Prior clinical experience preferred.
• Some organizations may require 2 years of clinical experience.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Knowledge of applicable protocol requirements as provided in company training.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at

Clinical Research Associate, Site Management - Italy

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R/R Shiny Developer in Clinical Trials

Milano, Lombardia PSI CRO AG

Inserito 2 giorni fa

Lavoro visualizzato

Tocca di nuovo per chiudere

Descrizione Del Lavoro

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Actual position's title: Clinical Data Scientist

Reporting to the Clinical Data Science Manager, the Clinical Data Scientist is an integral part of our team here at PSI. You will work with clinical trials patient and operational data, develop new data solutions and set up Risk-based Monitoring systems in Process Improvement department.

  • Setting up and maintaining risk-based monitoring (RBM) systems and analytical tools in collaboration with Central Monitoring Managers and Medical teams. Developing and programming Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Tables, Figures, and Listings (TFLs) to enable proactive trial oversight
  • Programming and maintaining interactive dashboards and Patient Profiles using R and R Shiny to visualize clinical trial data and support medical review and risk assessment
  • Participating in managing and transforming complex datasets from multiple sources and integrating them into the PSI data platform for analysis
  • Advising on and contributing to the development of new tools and methodologies for clinical trial analytics and risk-based monitoring
  • Ensuring compliance with regulatory standards, quality expectations, and best practices in clinical trial data management
  • Collaborating cross-functionally to identify study-level challenges and deliver tailored data-driven solutions
Qualifications

Must have:

  • Degree in Data Science, Mathematics, Statistics, Computer Science or equivalent
  • Minimum 4 years of R and R Shiny programming experience in Clinical/Pharmaceutical domain
  • Experience in custom R Shiny application development, preferably using structured frameworks such as golem, with a solid understanding of modular architecture and functional programming practices.
  • Proven proficiency in one or more R visualization and reporting packages, such as shiny, R Markdown.
  • Solid data wrangling skills in R, with hands-on experience using packages such as dplyr, lubridate.
  • Experience working with diverse data sources, including relational databases, Excel files, and SAS datasets.
  • Practical experience in developing and maintaining R packages, with a focus on reusability, robustness, and collaborative development.
  • Familiarity with version control workflows, including Git and working within a central code repository.
  • Full professional proficiency in English
  • Strong analytical and logical thinking
  • Communication and collaboration skills

Nice to have:

  • Experience in data engineering area including one or more of the following: relationship databases, data warehousing, data schemas, data stores, data modeling
  • Object-oriented programming for R ~ R6 (R)
  • Atlassian Products: Jira, Confluence
  • Experience with CluePoints RBM system
  • Knowledge of statistical methodsand techniques for analyzing data
  • Experienceusing Machine Learning technics andproducts testing and validation
Additional Information

What we offer:

  • We value your time so the recruitment process is as quick as 3 meetings
  • We'll prepare you to do your job at highest quality level with our extensive onboarding and mentorship program
  • You'll have excellent working conditions - spacious and modern office in convenient location, and friendly, supportive team who love to hang out together
  • You'll havepermanent work agreement at a stable, privately owned company
  • We care about our employees - aside from competitive salary, you'll have good work-life balance with flexible working hours and additional days off, life and medical insurance, sports card, lunch card
  • We're constantly growing which meansopportunities for personal and professional growth

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

#J-18808-Ljbffr
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R/R Shiny Developer in Clinical Trials

Lombardia, Lombardia PSI CRO AG

Inserito 3 giorni fa

Lavoro visualizzato

Tocca di nuovo per chiudere

Descrizione Del Lavoro

workfromhome
Company

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Actual position's title: Clinical Data Scientist

Reporting to the Clinical Data Science Manager, the Clinical Data Scientist is an integral part of our team here at PSI. You will work with clinical trials patient and operational data, develop new data solutions and set up Risk-based Monitoring systems in Process Improvement department. Hybrid work in Milan.

Responsibilities
  • Setting up and maintaining risk-based monitoring (RBM) systems and analytical tools in collaboration with Central Monitoring Managers and Medical teams. Developing and programming Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Tables, Figures, and Listings (TFLs) to enable proactive trial oversight
  • Programming and maintaining interactive dashboards and Patient Profiles using R and R Shiny to visualize clinical trial data and support medical review and risk assessment
  • Participating in managing and transforming complex datasets from multiple sources and integrating them into the PSI data platform for analysis
  • Advising on and contributing to the development of new tools and methodologies for clinical trial analytics and risk-based monitoring
  • Ensuring compliance with regulatory standards, quality expectations, and best practices in clinical trial data management
  • Collaborating cross-functionally to identify study-level challenges and deliver tailored data-driven solutions
Qualifications Must have
  • Degree in Data Science, Mathematics, Statistics, Computer Science or equivalent
  • Minimum 4 years of R and R Shiny programming experience in Clinical/Pharmaceutical domain
  • Experience in custom R Shiny application development, preferably using structured frameworks such as golem, with a solid understanding of modular architecture and functional programming practices.
  • Proven proficiency in one or more R visualization and reporting packages, such as shiny, R Markdown.
  • Solid data wrangling skills in R, with hands-on experience using packages such as dplyr, lubridate.
  • Experience working with diverse data sources, including relational databases, Excel files, and SAS datasets.
  • Practical experience in developing and maintaining R packages, with a focus on reusability, robustness, and collaborative development.
  • Familiarity with version control workflows, including Git and working within a central code repository.
  • Full professional proficiency in English
  • Strong analytical and logical thinking
  • Communication and collaboration skills
Nice to have
  • Experience in data engineering area including one or more of the following: relationship databases, data warehousing, data schemas, data stores, data modeling
  • Experience in R Shiny frontend customization using CSS and JavaScript for enhanced user interface and interactivity.
  • Object-oriented programming for R : R6 (R)
  • Azure Services: DevOps, Synapse
  • Atlassian Products: Jira, Confluence
  • Experience with CluePoints RBM system
  • Knowledge of statistical methods and techniques for analyzing data
  • Experience using Machine Learning technics and products testing and validation
Additional Information What we offer
  • We value your time so the recruitment process is as quick as 3 meetings
  • We'll prepare you to do your job at highest quality level with our extensive onboarding and mentorship program
  • You'll have excellent working conditions - spacious and modern office in convenient location, and friendly, supportive team who love to hang out together
  • You'll have permanent work agreement at a stable, privately owned company
  • We care about our employees - aside from competitive salary, you'll have good work-life balance with flexible working hours and additional days off, life and medical insurance, sports card, lunch card
  • We're constantly growing which means opportunities for personal and professional growth

Please submit your CV in English.

Seniority level
  • Associate
Employment type
  • Full-time
Job function
  • Analyst
Industries
  • Pharmaceutical Manufacturing
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R / R Shiny Developer in Clinical Trials

Milano, Lombardia PSI CRO

Inserito 23 giorni fa

Lavoro visualizzato

Tocca di nuovo per chiudere

Descrizione Del Lavoro

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Actual position's title: Clinical Data Scientist

Reporting to the Clinical Data Science Manager, the Clinical Data Scientist is an integral part of our team here at PSI. You will work with clinical trials patient and operational data, develop new data solutions and set up Risk-based Monitoring systems in Process Improvement department.

Hybrid work in Milan

  • Setting up and maintaining risk-based monitoring (RBM) systems and analytical tools in collaboration with Central Monitoring Managers and Medical teams. Developing and programming Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Tables, Figures, and Listings (TFLs) to enable proactive trial oversight
  • Programming and maintaining interactive dashboards and Patient Profiles using R and R Shiny to visualize clinical trial data and support medical review and risk assessment
  • Participating in managing and transforming complex datasets from multiple sources and integrating them into the PSI data platform for analysis
  • Advising on and contributing to the development of new tools and methodologies for clinical trial analytics and risk-based monitoring
  • Ensuring compliance with regulatory standards, quality expectations, and best practices in clinical trial data management
  • Collaborating cross-functionally to identify study-level challenges and deliver tailored data-driven solutions
Qualifications

Must have:

  • Degree in Data Science, Mathematics, Statistics, Computer Science or equivalent
  • Minimum 4 years of R and R Shiny programming experience in Clinical/Pharmaceutical domain
  • Experience in custom R Shiny application development, preferably using structured frameworks such as golem, with a solid understanding of modular architecture and functional programming practices.
  • Proven proficiency in one or more R visualization and reporting packages, such as shiny, R Markdown.
  • Solid data wrangling skills in R, with hands-on experience using packages such as dplyr, lubridate.
  • Experience working with diverse data sources, including relational databases, Excel files, and SAS datasets.
  • Practical experience in developing and maintaining R packages, with a focus on reusability, robustness, and collaborative development.
  • Familiarity with version control workflows, including Git and working within a central code repository.
  • Full professional proficiency in English
  • Strong analytical and logical thinking
  • Communication and collaboration skills

Nice to have:

  • Experience in data engineering area including one or more of the following: relationship databases, data warehousing, data schemas, data stores, data modeling
  • Experience in R Shiny frontend customization using CSS and JavaScript for enhanced user interface and interactivity.
  • Object-oriented programming for R ~ R6 (R)
  • Azure Services: DevOps, Synapse
  • Atlassian Products: Jira, Confluence
  • Experience with CluePoints RBM system
  • Knowledge of statistical methodsand techniques for analyzing data
  • Experienceusing Machine Learning technics andproducts testing and validation
Additional Information

What we offer:

  • We value your time so the recruitment process is as quick as 3 meetings
  • We'll prepare you to do your job at highest quality level with our extensive onboarding and mentorship program
  • You'll have excellent working conditions - spacious and modern office in convenient location, and friendly, supportive team who love to hang out together
  • You'll havepermanent work agreement at a stable, privately owned company
  • We care about our employees - aside from competitive salary, you'll have good work-life balance with flexible working hours and additional days off, life and medical insurance, sports card, lunch card
  • We're constantly growing which meansopportunities for personal and professional growth

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

Please submit your CV in English

#J-18808-Ljbffr
Siamo spiacenti, questo lavoro non è disponibile nella tua regione

R / R Shiny Developer in Clinical Trials

Lombardia, Lombardia PSI CRO

Oggi

Lavoro visualizzato

Tocca di nuovo per chiudere

Descrizione Del Lavoro

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Actual position's title: Clinical Data Scientist

Reporting to the Clinical Data Science Manager, the Clinical Data Scientist is an integral part of our team here at PSI. You will work with clinical trials patient and operational data, develop new data solutions and set up Risk-based Monitoring systems in Process Improvement department.

Hybrid work in Milan

  • Setting up and maintaining risk-based monitoring (RBM) systems and analytical tools in collaboration with Central Monitoring Managers and Medical teams. Developing and programming Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Tables, Figures, and Listings (TFLs) to enable proactive trial oversight
  • Programming and maintaining interactive dashboards and Patient Profiles using R and R Shiny to visualize clinical trial data and support medical review and risk assessment
  • Participating in managing and transforming complex datasets from multiple sources and integrating them into the PSI data platform for analysis
  • Advising on and contributing to the development of new tools and methodologies for clinical trial analytics and risk-based monitoring
  • Ensuring compliance with regulatory standards, quality expectations, and best practices in clinical trial data management
  • Collaborating cross-functionally to identify study-level challenges and deliver tailored data-driven solutions
Qualifications

Must have:

  • Degree in Data Science, Mathematics, Statistics, Computer Science or equivalent
  • Minimum 4 years of R and R Shiny programming experience in Clinical/Pharmaceutical domain
  • Experience in custom R Shiny application development, preferably using structured frameworks such as golem, with a solid understanding of modular architecture and functional programming practices.
  • Proven proficiency in one or more R visualization and reporting packages, such as shiny, R Markdown.
  • Solid data wrangling skills in R, with hands-on experience using packages such as dplyr, lubridate.
  • Experience working with diverse data sources, including relational databases, Excel files, and SAS datasets.
  • Practical experience in developing and maintaining R packages, with a focus on reusability, robustness, and collaborative development.
  • Familiarity with version control workflows, including Git and working within a central code repository.
  • Full professional proficiency in English
  • Strong analytical and logical thinking
  • Communication and collaboration skills

Nice to have:

  • Experience in data engineering area including one or more of the following: relationship databases, data warehousing, data schemas, data stores, data modeling
  • Experience in R Shiny frontend customization using CSS and JavaScript for enhanced user interface and interactivity.
  • Object-oriented programming for R ~ R6 (R)
  • Azure Services: DevOps, Synapse
  • Atlassian Products: Jira, Confluence
  • Experience with CluePoints RBM system
  • Knowledge of statistical methodsand techniques for analyzing data
  • Experienceusing Machine Learning technics andproducts testing and validation
Additional Information

What we offer:

  • We value your time so the recruitment process is as quick as 3 meetings
  • We'll prepare you to do your job at highest quality level with our extensive onboarding and mentorship program
  • You'll have excellent working conditions - spacious and modern office in convenient location, and friendly, supportive team who love to hang out together
  • You'll havepermanent work agreement at a stable, privately owned company
  • We care about our employees - aside from competitive salary, you'll have good work-life balance with flexible working hours and additional days off, life and medical insurance, sports card, lunch card
  • We're constantly growing which meansopportunities for personal and professional growth

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

Please submit your CV in English

#J-18808-Ljbffr
Siamo spiacenti, questo lavoro non è disponibile nella tua regione

R/R Shiny Developer in Clinical Trials

Lombardia, Lombardia PSI CRO AG

Oggi

Lavoro visualizzato

Tocca di nuovo per chiudere

Descrizione Del Lavoro

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Actual position's title: Clinical Data Scientist

Reporting to the Clinical Data Science Manager, the Clinical Data Scientist is an integral part of our team here at PSI. You will work with clinical trials patient and operational data, develop new data solutions and set up Risk-based Monitoring systems in Process Improvement department.

  • Setting up and maintaining risk-based monitoring (RBM) systems and analytical tools in collaboration with Central Monitoring Managers and Medical teams. Developing and programming Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Tables, Figures, and Listings (TFLs) to enable proactive trial oversight
  • Programming and maintaining interactive dashboards and Patient Profiles using R and R Shiny to visualize clinical trial data and support medical review and risk assessment
  • Participating in managing and transforming complex datasets from multiple sources and integrating them into the PSI data platform for analysis
  • Advising on and contributing to the development of new tools and methodologies for clinical trial analytics and risk-based monitoring
  • Ensuring compliance with regulatory standards, quality expectations, and best practices in clinical trial data management
  • Collaborating cross-functionally to identify study-level challenges and deliver tailored data-driven solutions
Qualifications

Must have:

  • Degree in Data Science, Mathematics, Statistics, Computer Science or equivalent
  • Minimum 4 years of R and R Shiny programming experience in Clinical/Pharmaceutical domain
  • Experience in custom R Shiny application development, preferably using structured frameworks such as golem, with a solid understanding of modular architecture and functional programming practices.
  • Proven proficiency in one or more R visualization and reporting packages, such as shiny, R Markdown.
  • Solid data wrangling skills in R, with hands-on experience using packages such as dplyr, lubridate.
  • Experience working with diverse data sources, including relational databases, Excel files, and SAS datasets.
  • Practical experience in developing and maintaining R packages, with a focus on reusability, robustness, and collaborative development.
  • Familiarity with version control workflows, including Git and working within a central code repository.
  • Full professional proficiency in English
  • Strong analytical and logical thinking
  • Communication and collaboration skills

Nice to have:

  • Experience in data engineering area including one or more of the following: relationship databases, data warehousing, data schemas, data stores, data modeling
  • Object-oriented programming for R ~ R6 (R)
  • Atlassian Products: Jira, Confluence
  • Experience with CluePoints RBM system
  • Knowledge of statistical methodsand techniques for analyzing data
  • Experienceusing Machine Learning technics andproducts testing and validation
Additional Information

What we offer:

  • We value your time so the recruitment process is as quick as 3 meetings
  • We'll prepare you to do your job at highest quality level with our extensive onboarding and mentorship program
  • You'll have excellent working conditions - spacious and modern office in convenient location, and friendly, supportive team who love to hang out together
  • You'll havepermanent work agreement at a stable, privately owned company
  • We care about our employees - aside from competitive salary, you'll have good work-life balance with flexible working hours and additional days off, life and medical insurance, sports card, lunch card
  • We're constantly growing which meansopportunities for personal and professional growth

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

#J-18808-Ljbffr
Siamo spiacenti, questo lavoro non è disponibile nella tua regione

R/R Shiny Developer in Clinical Trials

Lombardia, Lombardia PSI CRO AG

Oggi

Lavoro visualizzato

Tocca di nuovo per chiudere

Descrizione Del Lavoro

Company

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Actual position's title: Clinical Data Scientist

Reporting to the Clinical Data Science Manager, the Clinical Data Scientist is an integral part of our team here at PSI. You will work with clinical trials patient and operational data, develop new data solutions and set up Risk-based Monitoring systems in Process Improvement department. Hybrid work in Milan.

Responsibilities
  • Setting up and maintaining risk-based monitoring (RBM) systems and analytical tools in collaboration with Central Monitoring Managers and Medical teams. Developing and programming Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Tables, Figures, and Listings (TFLs) to enable proactive trial oversight
  • Programming and maintaining interactive dashboards and Patient Profiles using R and R Shiny to visualize clinical trial data and support medical review and risk assessment
  • Participating in managing and transforming complex datasets from multiple sources and integrating them into the PSI data platform for analysis
  • Advising on and contributing to the development of new tools and methodologies for clinical trial analytics and risk-based monitoring
  • Ensuring compliance with regulatory standards, quality expectations, and best practices in clinical trial data management
  • Collaborating cross-functionally to identify study-level challenges and deliver tailored data-driven solutions
QualificationsMust have
  • Degree in Data Science, Mathematics, Statistics, Computer Science or equivalent
  • Minimum 4 years of R and R Shiny programming experience in Clinical/Pharmaceutical domain
  • Experience in custom R Shiny application development, preferably using structured frameworks such as golem, with a solid understanding of modular architecture and functional programming practices.
  • Proven proficiency in one or more R visualization and reporting packages, such as shiny, R Markdown.
  • Solid data wrangling skills in R, with hands-on experience using packages such as dplyr, lubridate.
  • Experience working with diverse data sources, including relational databases, Excel files, and SAS datasets.
  • Practical experience in developing and maintaining R packages, with a focus on reusability, robustness, and collaborative development.
  • Familiarity with version control workflows, including Git and working within a central code repository.
  • Full professional proficiency in English
  • Strong analytical and logical thinking
  • Communication and collaboration skills
Nice to have
  • Experience in data engineering area including one or more of the following: relationship databases, data warehousing, data schemas, data stores, data modeling
  • Experience in R Shiny frontend customization using CSS and JavaScript for enhanced user interface and interactivity.
  • Object-oriented programming for R : R6 (R)
  • Azure Services: DevOps, Synapse
  • Atlassian Products: Jira, Confluence
  • Experience with CluePoints RBM system
  • Knowledge of statistical methods and techniques for analyzing data
  • Experience using Machine Learning technics and products testing and validation
Additional InformationWhat we offer
  • We value your time so the recruitment process is as quick as 3 meetings
  • We'll prepare you to do your job at highest quality level with our extensive onboarding and mentorship program
  • You'll have excellent working conditions - spacious and modern office in convenient location, and friendly, supportive team who love to hang out together
  • You'll have permanent work agreement at a stable, privately owned company
  • We care about our employees - aside from competitive salary, you'll have good work-life balance with flexible working hours and additional days off, life and medical insurance, sports card, lunch card
  • We're constantly growing which means opportunities for personal and professional growth

Please submit your CV in English.

Seniority level
  • Associate
Employment type
  • Full-time
Job function
  • Analyst
Industries
  • Pharmaceutical Manufacturing
#J-18808-Ljbffr
Siamo spiacenti, questo lavoro non è disponibile nella tua regione
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Informazioni sulle ultime novità Clinical trials Posti di lavoro;/Posti Vacanti nella Lombardia !

Drug Product Development Proposal Specialist

Monza, Lombardia Thermo Fisher Scientific

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Descrizione Del Lavoro

**As a Drug Product Development Proposal Specialist you will**:

- Initiate local quotation activities once site selection has been confirmed.
- Review technical strategy from SMEs ensuring alignment with customers needs. Dialogue with SME for alternative solutions or scope when appropriate.
- Responsible for building the draft technical scope, high level timelines and price estimates for the bid proposal using current quoting processes, tools and templates.
- Where appropriate, working with the Legal / Contracts function to ensure that the accurate legal terms and conditions are applied to a given proposal.
- Ensuring that the appropriate proposal review and authorization have been acquired from site SMEs and management; this may include supporting deal pricing / margin discussions with Site Leadership.
- Support the Sales team on teleconferences or site visits with the client to confirm the technical aspects of projects are understood and priced appropriately together with gaining an understanding of the actions needed to progress a given deal towards successful closure and assisting / coordinating internally as necessary.
- Coordinating the transition of the project information with technical contacts & project management team for all awarded projects. This includes the timely "file dropping" of quoting information into Change-Point.
- Provide assistance to general enquiries raised by the Sales group.
- Work with Business Development Executives, Site Leadership and Project Managers to promote Patheon and ensure client happiness.
- Must be prepared to present and discuss quotation aspects and analysis to all levels of the organization.
- Participate in continuous improvements within the proposals process.
- Where applicable, performs job responsibilities in compliance with cGMP and all other regulatory agency requirements

**Requirements**:

- Minimum Bachelor level education (B.Sc. or Eng) or equivalent professional experience.
- Very good level of English and Italian language
- spoken and written
- Proficiency with Microsoft Office suite (Outlook, Word, Excel, Power Point)
- Well organized, detail oriented and willing to work in a client facing environment
- Strong communication skills and the ability to work successfully within a diverse group of colleagues in various locations around the globe
- Ability to prioritize multiple tasks, projects and driven towards results
- Ideally hold pharmaceutical services experience, in a pharma development / technical role. Experience in other areas will be evaluated as well (medical devices, cosmetics, chemical).

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain **5 reasons to work with us**. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve sophisticated scientific challenges, drive technological innovation and support patients in need. **#StartYourStory at Thermo Fisher Scientific**, where diverse experiences, backgrounds and perspectives are valued.

Does this sound like something you are interested in?
Applications will be reviewed constantly and the position will be filled once we find the suitable team member.
- Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status._
Siamo spiacenti, questo lavoro non è disponibile nella tua regione

Clinical Research Associate

Lombardia, Lombardia Medpace

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Descrizione Del Lavoro

workfromhome

Job Summary

The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with a medical and / or health / life science background who want to explore the research field and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you!

Our successful Clinical Research Associates possess various backgrounds in medical and other science-related healthcare fields. Backgrounds of individuals who have succeeded in the CRA role include :

  • Nursing
  • Dietetics
  • Pharmacist
  • Pharmaceutical / Device Sales Representative
  • Biomedical / Chemical Engineer
  • PhD / Post-Doc
  • Pharm.D candidate
  • Health and Wellness Coordinators
  • Clinical Research Coordinators
  • Research Assistants
MEDPACE CRA TRAINING PROGRAM (PACE)

No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other P rofessionals A chieving C RA E xcellence :

  • PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA.
  • PACE will prepare you by developing your CRA skills through interactive discussions and hands-on job-related exercises and practicum s.
  • To supplement your in-house and field-based training, you may also participate in other clinical research departmental core rotations, learning other aspects of the drug / device development and approval process.
Responsibilities
  • Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol.
  • Communicate with the medical site staff including coordinators, clinical research physicians, and their site staff.
  • Verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff.
  • Verify medical record and research source documentation against case report form data, including informing the site staff of any entry errors and ensuring good documentation practices are adhered to.
  • Verify that the investigator is enrolling only eligible subjects.
  • Review regulatory documents.
  • Accountability and inventory of medical devices and / or investigational products / drugs.
  • Verify and review adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.
  • Assess the clinical research site’s patient recruitment and retention success and offer suggestions for improvement.
  • Complete monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications
  • Master's degree in a health-related field.
  • Willingness to travel 60-80% nationally.
  • Familiarity with Microsoft Office.
  • CRA certification completed as per DMC 15 / 11 / 2011.
  • Fluency in English and Italian.
  • Strong communication and presentation skills are a plus.
Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach.

Medpace Perks
  • Flexible work environment.
  • Competitive compensation and benefits package.
  • Competitive PTO packages.
  • Structured career paths with opportunities for professional growth.
  • Company-sponsored employee appreciation events.
  • Employee health and wellness initiatives.
Awards
  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024.
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.
What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for the next steps.

EO / AA Employer M / F / Disability / Vets

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Clinical Research Associate

Bergamo, Lombardia Veeda Lifesciences

Inserito 3 giorni fa

Lavoro visualizzato

Tocca di nuovo per chiudere

Descrizione Del Lavoro

Heads, a global CRO and part of Veeda Lifesciences, is seeking a Clinical Research Associate (CRA) based in Italy for its expanding international hematology/oncology clinical trials program.

This is a full-time position.

Job Overview:

The CRA is responsible for ensuring that the conduct of clinical trials at selected investigational sites complies with approved protocols, ICH GCP guidelines, SOPs, and applicable laws and regulations. They serve as the primary communication link between the sponsor, investigators, and study personnel, ensuring the rights of subjects are protected and data collected are accurate, complete, and verifiable.

Main Responsibilities:
  • Ensure compliance with quality and information security systems, ICH GCP, local and international legislation, including data protection laws.
  • Report deviations from protocols or regulations to line management as per SOPs.
  • Conduct pre-study site visits to evaluate resources and facilities.
  • Collaborate with regulatory and clinical operations teams for submissions and contracts.
  • Explain study procedures to investigators and provide training.
  • Maintain and update clinical trial files and ensure proper documentation.
  • Manage study medication supplies, including shipment, storage, and accountability.
  • Monitor trial conduct at sites, ensuring investigator compliance and data integrity.
  • Verify informed consent and oversee safety reporting.
  • Prepare monitoring reports and participate in study meetings.
  • Assist with audits and inspections, ensuring corrective actions are implemented.
  • Support site feasibility, patient recruitment, and study closure activities.
  • Contribute to SOP development and departmental planning.
  • Provide coaching and mentorship to less experienced CRAs.
Job Requirements:
  • Bachelor’s or Master’s in Health Sciences preferred.
  • Certified CRA.
  • 6-12 months CRA work experience.
  • Fluent in English and Italian, both oral and written.
  • Desirable: Completion of an ICH GCP training course.
  • Proficient in computer skills and effective communication.
  • Strong organizational skills and ability to work independently and in teams.
  • Capacity to handle stressful situations and manage multiple issues.
  • Willingness to travel frequently, including international trips, evenings, and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals in a dynamic and friendly environment. We offer a competitive remuneration package.

We value data protection as a core principle and are committed to respecting your privacy. For details on data processing, please visit our Privacy Notice to Candidates.

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