107 Posti di lavoro per Gestione Di Studi Clinici in Italia

Senior Clinical Trial Coordinator

37121 Verona, Veneto Alira Health Group

Inserito 5 giorni fa

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Descrizione Del Lavoro

Performs additional duties as assigned.* Graduation in scientific/health field* Good knowledge of Clinical Research and Regulatory/Ethical requirementsPrevious experience in clinical research (in CROs, Pharma or academy/hospital experience)Good knowledge of ICH GCP and appropriate regulations* English, good* MS Office Suite, good* Professional* Trustworthy* Quality focused; ability to be careful, thorough, and detail-oriented* Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; able to manage priorities and organize time* Strong analytical skills* Strong communication and interpersonal skills with customer service orientationWith offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork.We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.
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Sr Clinical Trial Manager - Italy

Milano, Lombardia Syneos Health

Inserito 7 giorni fa

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Descrizione Del Lavoro

Sr Clinical Trial Manager - Italy

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

  • Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
  • Reviews the study scope of work, budget and protocol content and ensures the clinical project team is aware of the contractual obligations and parameters.
  • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
  • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.
  • Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones.
  • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
  • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form completion, dashboards, Sponsor Standard Operating Procedures, clinical plans and guidelines, data plans and timelines for the study.
  • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
  • Reviews the project oversight dashboards and other clinical trial systems to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects.
  • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan.
  • Reviews the content and quality of site and central monitoring documentation to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity.
  • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
  • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
  • Supports Inspection Readiness for clinical trial management scope.
  • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
  • Provides feedback to line managers on staff performance including strengths as well as areas for development.
  • May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects.
  • May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation.

Qualifications

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
  • Demonstrated ability to lead and align teams in the achievement of project milestones.
  • Demonstrated capability of working in an international environment.
  • Demonstrated expertise in site management and monitoring (clinical or central).
  • Preferred experience with risk-based monitoring.
  • Demonstrates understanding of clinical trial management financial principles and budget management.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Must demonstrate good computer skills.
  • Strong conflict resolution skills.
  • Demonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
  • Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
  • Moderate travel may be required, approximately 20%.

Syneos Health is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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Clinical Trial Coordinator - Segrate, Milan

Lombardia, Lombardia Experteer Italy

Inserito 3 giorni fa

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Descrizione Del Lavoro

Clinical Trial Coordinator - Segrate, Milan

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.

Who is PPD Clinical Research Services? PPD is a leading global contract research organization. Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies.

Job Description

You will provide technical support to the project team, coordinating non-clinical responsibilities of project administration. Additional key responsibilities include:

  • Performs PPD investigator file reviews and logging of outstanding issues in project related tracking tools
  • Reviews regulatory documents for proper content
  • Liaises with monitor and investigative sites to resolve outstanding regulatory issues identified
  • Disseminates study related information, including project tracking updates to clients, clinical study teams and other PPD departments
  • Responsible for adhering to Good Clinical Practices, country specific regulations, PPD/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout
  • Assists with the identification of potential investigators and development/distribution of initial protocol packets
  • Creates meeting agendas and minutes, as well as coordinates team conference calls and distribution of meeting minutes
Education and Experience

Required:

  • Master's degree (ideally within a clinical specialism), or equivalent education, training and experience
  • Experience with Submissions to Ethics Committees and Regulatory bodies (desired)
  • Ability to effectively analyse project specific data/systems to ensure accuracy and efficiency
  • Experience of manage multiple projects with differing priorities at one given time
  • Exceptional communication, collaboration, organisational and time management skills
What We Offer

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. 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 complex scientific challenges, drive technological innovation and support patients in need.

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Clinical Trial Coordinator - Segrate, Milan

Milano, Lombardia Thermo Fisher Scientific

Inserito 7 giorni fa

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Descrizione Del Lavoro

Overview

Clinical Trial Coordinator – Segrate, Milan. At Thermo Fisher Scientific, you’ll contribute to a global mission by supporting clinical trials and delivering life-changing therapies. Our work spans laboratory, digital, and decentralized clinical trial services across 100+ countries, with a focus on quality and accuracy to improve health outcomes.

Responsibilities
  • Performs PPD investigator file reviews and logging of outstanding issues in project-related tracking tools
  • Reviews regulatory documents for proper content
  • Liaises with monitors and investigative sites to resolve outstanding regulatory issues identified
  • Disseminates study-related information, including project tracking updates to clients, clinical study teams and other PPD departments
  • Adheres to Good Clinical Practices, country-specific regulations, PPD/Client Standard Operating Procedures and Working Practice Documents for all non-clinical/clinical aspects of project implementation, execution, and closeout
  • Assists with the identification of potential investigators and development/distribution of initial protocol packets
  • Creates meeting agendas and minutes, and coordinates team conference calls with distribution of meeting minutes
Qualifications
  • Master's degree (ideally within a clinical specialism), or equivalent education, training and experience
  • Experience with Submissions to Ethics Committees and Regulatory bodies (desired)
  • Ability to effectively analyse project-specific data/systems to ensure accuracy and efficiency
  • Experience managing multiple projects with differing priorities
  • Exceptional communication, collaboration, organisational and time management skills
What We Offer

At Thermo Fisher Scientific, you will benefit from an award-winning learning and development programme and a competitive salary with an extensive benefits package focused on health and well-being. We support a flexible working culture and work-life balance within a collaborative, global organization with a local feel.

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Clinical Trial Coordinator - Segrate, Milan

ThermoFisher Scientific

Inserito 16 giorni fa

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Descrizione Del Lavoro

**Work Schedule**
Other
**Environmental Conditions**
Office
**Job Description**
**Clinical Trial Coordinator - Segrate, Milan**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Who is PPD Clinical Research Services? **
PPD is a leading global contract research organization.  Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies. Our strategy is to bend the cost and time curve of drug development and optimize value for our customers.  PPD is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine
**Clinical Trial Coordinator**
You will provide technical support to the project team, coordinating non-clinical responsibilities of project administration. Additional key responsibilities include:
+ Performs PPD investigator file reviews and logging of outstanding issues in project related tracking tools
+ Reviews regulatory documents for proper content
+ Liaises with monitor and investigative sites to resolve outstanding regulatory issues identified
+ Disseminates study related information, including project tracking updates to clients, clinical study teams and other PPD departments
+ Responsible for adhering to Good Clinical Practices, country specific regulations, PPD/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout
+ Assists with the identification of potential investigators and development/distribution of initial protocol packets
+ Creates meeting agendas and minutes, as well as coordinates team conference calls and distribution of meeting minutes
**Education and Experience:**
+ Master's degree (ideally within a clinical specialism), or equivalent education, training and experience
+ Experience with Submissions to Ethics Committees and Regulatory bodies (desired)
+ Ability to effectively analyse project specific data/systems to ensure accuracy and efficiency
+ Experience of manage multiple projects with differing priorities at one given time
+ Exceptional communication, collaboration, organisational and time management skills
**What We Offer**
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture , where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
**Mission/4i Values**
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 complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! 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.
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Sr Clinical Trial Manager - Italy

Lombardia, Lombardia Syneos Health

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Descrizione Del Lavoro

Sr Clinical Trial Manager - Italy

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

  • Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
  • Reviews the study scope of work, budget and protocol content and ensures the clinical project team is aware of the contractual obligations and parameters.
  • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
  • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.
  • Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones.
  • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
  • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form completion, dashboards, Sponsor Standard Operating Procedures, clinical plans and guidelines, data plans and timelines for the study.
  • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
  • Reviews the project oversight dashboards and other clinical trial systems to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects.
  • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan.
  • Reviews the content and quality of site and central monitoring documentation to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity.
  • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
  • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
  • Supports Inspection Readiness for clinical trial management scope.
  • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
  • Provides feedback to line managers on staff performance including strengths as well as areas for development.
  • May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects.
  • May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation.

Qualifications

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
  • Demonstrated ability to lead and align teams in the achievement of project milestones.
  • Demonstrated capability of working in an international environment.
  • Demonstrated expertise in site management and monitoring (clinical or central).
  • Preferred experience with risk-based monitoring.
  • Demonstrates understanding of clinical trial management financial principles and budget management.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Must demonstrate good computer skills.
  • Strong conflict resolution skills.
  • Demonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
  • Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
  • Moderate travel may be required, approximately 20%.

Syneos Health is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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Senior / Clinical Trial Manager - Oncology - Europe - Remote

Worldwide Clinical Trials

Inserito 3 giorni fa

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Descrizione Del Lavoro

workfromhome

Overview

Senior / Clinical Trial Manager - Oncology - Europe - Remote

We’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’re Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What Clinical Operations Site Management Does At Worldwide

Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) play a vital role in ensuring our clinical research programs are executed with the quality and excellence our sponsors expect and the care and passion patients deserve. These roles are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role in every clinical trial. All CROs will promise you growth, opportunity, and maybe even a challenge. But we offer more than that. We offer an uncommon experience – one you can’t get anywhere else, with a team unlike anyone else. At Worldwide we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

What You Will Do
  • Provide leadership and direction to clinical site management team members from study start through to closure
  • Serve as Site Management’s primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to
  • Primary Sponsor Contact
  • Manage monitoring deliverables to achieve the study budget and identify Out of Scope Activities
What You Will Bring To The Role
  • Excellent interpersonal, oral, and written communication skills in English
  • Ability to lead and motivate a team remotely
  • Demonstrate initiative and problem-solving skills by offering solutions when obstacles are identified
  • Strong customer focus, ability to interact professionally within a sponsor contact
  • Proficiency in Microsoft Office, CTMS, and EDC Systems
Your Experience
  • Bachelor’s Degree or a Nursing Degree required
  • 1+ years’ experience as a Clinical Trial Manager, Clinical Operations Leader, Lead CRA, or equivalent role
  • 3+ years’ experience as a Senior Clinical Research Associate
  • Candidates must currently be located in Europe
  • Oncology (solid tumor) experience is required
  • Willingness to travel up to 30%

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

Eligibility

Senior / Clinical Trial Manager - T2DM and/or Obesity - Europe - Remote

Regional Clinical Study Manager / Line Manager

Senior Manager, Quality Assurance (GCP Auditor)

Greater Naples Metropolitan Area 2 months ago

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Associate Clinical Trial Manager (PhD) - Neuroscience / Ophthalmology

Milano, Lombardia Medpace

Inserito 30 giorni fa

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Job Summary

Medpace is currently seeking candidates with PhDs and/or Post-Doctoral Research experience for a full-time, office-based Associate Clinical Trial Manager (aCTM) to join our Clinical Trial Management team. The aCTM will be a part of the Clinical Trial Management team working with Project Coordinators and Clinical Trial Managers in performance of clinical trial management activities. Candidate must have a desire to transfer and apply analytical and academic skills in clinical project administration and management.

A fantastic opportunity for recent PhD graduates to enter the industry, receive solid foundational training, work in an international environment, and develop their career in the research and development of cutting-edge therapeutics . Candidates should expect to have an intensive training period and show the desire and aptitude for an accelerated career path into Clinical Trial Management (CTM).

Responsibilities
  • Communicate and collaborate on global study activities; working closely with the project coordinator and clinical trial manager
  • Ensure timely delivery of recurrent tasks consistently with a high degree of accuracy
  • Compile and maintain project-specific status reports within the clinical trial management system
  • Interact with the internal project team, Sponsor, study sites, and third-party vendors
  • Manage and perform quality control of our internal regulatory filing system
  • Provide oversight and management of study supplies
  • Create and maintain project timelines
  • Coordinate project meetings and produce quality minutes
Qualifications
  • PhD in Life Sciences
  • Fluency in English with solid presentation skills
  • Ability to work in a fast-paced dynamic industry within an international team
  • Prior experience within the CRO or pharmaceutical industry not required but will be advantageous
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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

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 next steps.

EO/AA Employer M/F/Disability/Vets

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Senior / Clinical Trial Manager - Oncology - Europe - Remote

Worldwide Clinical Trials

Oggi

Lavoro visualizzato

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Descrizione Del Lavoro

Overview

Senior / Clinical Trial Manager - Oncology - Europe - Remote

We’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’re Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What Clinical Operations Site Management Does At Worldwide

Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) play a vital role in ensuring our clinical research programs are executed with the quality and excellence our sponsors expect and the care and passion patients deserve. These roles are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role in every clinical trial. All CROs will promise you growth, opportunity, and maybe even a challenge. But we offer more than that. We offer an uncommon experience – one you can’t get anywhere else, with a team unlike anyone else. At Worldwide we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

What You Will Do
  • Provide leadership and direction to clinical site management team members from study start through to closure
  • Serve as Site Management’s primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to
  • Primary Sponsor Contact
  • Manage monitoring deliverables to achieve the study budget and identify Out of Scope Activities
What You Will Bring To The Role
  • Excellent interpersonal, oral, and written communication skills in English
  • Ability to lead and motivate a team remotely
  • Demonstrate initiative and problem-solving skills by offering solutions when obstacles are identified
  • Strong customer focus, ability to interact professionally within a sponsor contact
  • Proficiency in Microsoft Office, CTMS, and EDC Systems
Your Experience
  • Bachelor’s Degree or a Nursing Degree required
  • 1+ years’ experience as a Clinical Trial Manager, Clinical Operations Leader, Lead CRA, or equivalent role
  • 3+ years’ experience as a Senior Clinical Research Associate
  • Candidates must currently be located in Europe
  • Oncology (solid tumor) experience is required
  • Willingness to travel up to 30%

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

Eligibility

Senior / Clinical Trial Manager - T2DM and/or Obesity - Europe - Remote

Regional Clinical Study Manager / Line Manager

Senior Manager, Quality Assurance (GCP Auditor)

Greater Naples Metropolitan Area 2 months ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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Clinical Trial Manager - Italy (Milan) - Infectious Disease / Immunology

Milano, Lombardia Medpace

Inserito 2 giorni fa

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Job Summary

Medpace is the leading CRO for Biotech companies and is continuing to add Clinical Trial Managers of different experience levels to join our Clinical Trial Management Group in our Milan office. Clinical Trial Managers with expertise in Immunology and Infectious Diseases are welcome to continue to work in their area of expertise or to expand to a new therapeutic area.We provide remote flexibility only with relevant experience (after probation). We offer a very competitive salary/bonus program, plus equity grants which have become very lucrative for our associates.

Responsibilities
  • Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
  • Serve as primary Sponsor contact for operational project-specific issues and study deliverables
  • Maintain in depth knowledge of protocol, therapeutic area, and indication
  • Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided
  • Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable
  • Develop operational project plans
  • Manage risk assessment and execution
  • Responsible for management of study vendor
  • Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables
Qualifications
  • Bachelor’s degree in a health or life science-related field; Advanced degree in a health or life science-related field preferred;
  • Experience in Phases 1-4; Phases 2-3 preferred;
  • Minimum of 2 years of Clinical Trial Management experience, CRO experience preferred;
  • 5+ years of Project Manager/Clinical Trial Manager experience at a CRO required for a remote-based role;
  • Management of overall project timeline;
  • Bid defense experience preferred; and
  • Strong leadership skills.
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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

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 next steps.

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