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MEDPACE

MEDPACE

 

 

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 4,000 people across almost 40 countries.

What is a Clinical Trial?

Clinical trials are research studies that determine the safety and efficacy of possible new treatments for a disease or illness. Medpace conducts trials involving drugs, devices, and laboratory services. Part of the clinical trial process involves rigorous research which is regulated and required prior to approval.

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

Throughout the clinical development life cycle, Medpace provides medical and regulatory leadership guidance and efficient, disciplined operational execution of studies around the world. Our comprehensive capabilities, resources and global footprint ensure quality and timely development across all phases of research.

Areas of Therapeutic Focus

Autoimmune Diseases

Cardiovascular

Endocrine & Metabolic

Gastroenterology

Hematology & Oncology

Infectious Diseases and Vaccines

NASH & Liver Disease; Neurology & Psychiatry

Nephrology

Ophthalmology

Pediatrics

Rare Diseases

Cellular & Gene Therapy

 

WHAT ARE YOU LOOKING FOR?

- Bachelor’s and Master’s Degree in Life Sciences or Health-related field (80%)
- PhD in Life Sciences (10%)
- Bachelor or Master in Law or Sciences (10%)

 

 

 

Company
Title

Regulatory Submissions Technical Advisor - Milan
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Job Summary

Our clinical operations activities are growing rapidly and we are currently seeking full-time, Regulatory Submissions Technical Advisors to join our Site Activation and Maintenance team, within Clinical Operations.

This position plays a key role at Medpace, preparing and reviewing regulatory documents and providing strategic regulatory advice to support clinical trial submissions. Medpace specialises in supporting mid-sized biopharma companies giving you the opportunity to work on complex and challenging trials, often involving new technologies and novel therapies.

If you want an exciting role where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you!

Responsibilities

  • Provide regulatory submissions strategic advice and guidance to the Regulatory Submissions Manager (RSM), Medpace project team, and Sponsor to ensure submissions compliance with appropriate regulations and requirements;
  • Prepare and/or review core trial documents for compliance with relevant guidelines/regulations and for trial suitability;
  • Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
  • Independently interact with Sponsors, regulatory agencies and Medpace colleagues; and
  • Present during bid defenses, general capabilities meetings, and audits, as required.

Qualifications

  • Bachelor’s degree in Life Sciences – Master’s/PhD preferred
  • Significant experience in clinical research, preferably with a CRO
  • Strong understanding of regulatory documentation, guidelines and legislation
  • Ability to review regulatory guidance and develop proactive solutions to regulatory issues and challenges
  • Experience in reviewing and/or writing core regulatory documents
  • Strong communication, critical thinking, and problem-solving skills
  • Ability to independently interact with national/regional regulatory agencies
  • Fluency in Italian and English.
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Data Coordinator
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Job Summary

Our corporate activities are growing rapidly, and we are currently seeking a full-time Data Coordinator to join our Data Management team in Italy. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

  • Participate as part of a team on various projects;
  • Validate an entry database design;
  • Report metrics and data trends on project(s);
  • Identify data conflicts and issues on project(s);
  • Work with personnel from research sites globally to resolve data conflicts;
  • Reconcile data from multiple sources;
  • Create and update study documentation on projects.

 

Qualifications

  • Bachelor's degree in a health related field
  • Strong attention to detail and working knowledge of Excel and Word
  • 1-2 years of experience in a pharmaceutical or CRO setting preferred.

 

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?

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

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Office Assistant
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Job Summary

Our corporate activities are growing rapidly, and we are currently seeking a full-time Office Assistant to support our team at our office in Milan. This position will work cross-functionally to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

  • Under general supervision, provides support for local office administration and reception desk;
  • Use internal facilities management software to manage planned and reactive maintenance tasks;
  • Under direction of the Finance function, may support local invoice flow; receiving and managing all the coming invoices using internal finance/invoice management systems;
  • Greets visitors and controls the booking meeting rooms, assisting with the coordination of the meetings or other events;
  • Coordinate administrative services including mail distribution, shipping and receiving, supply inventory, and front-line office support including reception;
  • Coordinate administration of building property, apartments, and company vehicles;
  • Submit office expense invoices within allocated budget, escalating approval when necessary;
  • Develop and maintain strong relationships with service vendors and landlords to ensure efficient maintenance of building and grounds;
  • Under supervision, responsible for coordination of all health and safety procedures for a local office;
  • Under direction of IT function coordinate management of office telephony needs, including mobile phones and printing services;
  • Provide reporting and information for country budget planning for facilities-related costs;
  • Develop understanding of appropriate Standard Operating Procedures (SOPs) and policies;
  • May be responsible for other projects and responsibilities as assigned.

 

Qualifications

  • Associate's Degree or equivalent or at least 2 years of experience in administrative services/office management
  • Basic knowledge in office management, Health and Safety, Risk Assessments and emergency procedures required
  • Knowledge of MS Word, Excel, and PowerPoint
  • Strong communication skills in Italian and English (both written and verbal)
  • Excellent organizational and prioritization skills with a high attention to detail.

 

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.

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Clinical Research Project Coordinator
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Job Summary

We are currently seeking a full-time, office-based Project Coordinator to join our Clinical Trial Management team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you can use your previous clinical research expertise and develop your career even further, then this is the opportunity for you.

Responsibilities

  • Engage in clinical trial management on a day to day level;
  • Work closely with the project CTM for timely delivery of recurrent tasks consistently with a high degree of accuracy;
  • Compile and maintain project-specific status reports;
  • Interact with the Sponsor, study sites, and internal associates;
  • Create and maintain project timelines;
  • Coordinate project meetings and produce quality minutes.

 

Qualifications

  • Bachelor's degree in a health sciences field
  • Prior experience as a Study Coordinator or within the pharmaceutical industry
  • Excellent computer (word-processing, databases, Excel, Windows), organizational, and communication 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 4,000 people across almost 40 countries.

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Clinical Contract Manager Study Start-up
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Job Summary

Our clinical operations activities are growing rapidly and we are currently seeking a full-time experienced Contract Manager to join our Site Activation and Maintenance team, within Clinical Operations.

Medpace specialises in supporting mid-sized biopharma companies giving you the opportunity to work on complex and challenging trials, often involving new technologies and novel therapies. If you want an exciting role where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you!

There is a possibility to work partially from home after 3-6 months after the start date.

Responsibilities

  • Responsible for managing contract & budget negotiations for assigned projects;
  • Play a key role in managing timelines;
  • Responsible for reporting contract & budget negotiation progress to internal and external project teams;
  • Serve as primary point of contact for internal and external project teams.

 

Qualifications

  • Bachelor’s degree
  • 4 years of contract management experience preferably in a clinical research or similar industry setting
  • Excellent communication, negotiation, and leadership skills
  • Fluent in English and Italian.

 

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.

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Manager - Regulatory Submissions (Study Start-up)
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Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Clinical Operations team in Leuven, Belgium. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

  • Efficiently manage and successfully execute all aspects of global start-up;
  • Perform quality checks on submission documents and site essential documents;
  • Prepare and approve informed consent forms;
  • Review pertinent regulations to develop proactive solutions to start-up issues and challenges;
  • Present during bid defenses, general capabilities meetings, and audits.

 

Qualifications

  • At least 4 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience
  • Knowledge and experience of Clinical Trial Applications within Europe
  • Strong oral and written communication skills
  • Team oriented approach and strong leadership skills
  • Fluency in English.

 

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 4,000 people across almost 40 countries.

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Regulatory Submissions Coordinator
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Job Summary

Our clinical activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Specialist to join our Clinical Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

  • Prepare, review, and file clinical trial applications to domestic and international regulatory agencies;
  • Ensure submissions comply with applicable regulations and guidance documents;
  • Advise sponsors on changing regulations and compliance requirements;
  • Track submissions and ensure timely filing of documents.

 

Qualifications

  • Minimum Bachelor's degree in Life Sciences
  • Experience as a Regulatory Submissions Coordinator for EC/RA applications in Italy
  • Excellent organization and communication skills
  • Knowledge of Microsoft® Office
  • Hands-on experience preparing, reviewing, and submitting regulatory documentation
  • Fluent in Italian and English.

 

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?

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

 

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Contract Specialist
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Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Contract Specialist to join our Clinical Operations team in Milan (Italy) office. This position plays a key role in the study start-up and clinical trial management processes at Medpace. The Contract Specialist will play a key role in advancing the start-up of our projects. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

  • Negotiate client approved contract and budget templates with clinical investigator sites;
  • Collaborate and work within a project team matrix to deliver on time results;
  • Keep up to date with applicable local regulations concerning clinical trials.

Qualifications

  • Bachelor's degree; preferable in Law or Sciences
  • At least 1 year of relevant work experience
  • Prior contract negotiation experience preferred but not required
  • Strong attention to detail and excellent communication skills
  • Excellent knowledge of the English and Italian languages.

 

Travel: None

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 4,000 people across almost 40 countries.

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

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Associate Clinical Trial Manager - Milan, Italy (PhD)
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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 in our Milan, Italy office. 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;
  • Provide oversight and 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.

 

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

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Clinical Research Associate
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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 candidates
  • Health and Wellness Coordinators
  • Clinical Research Coordinators
  • Research Assistants
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