Project Manager (m/f/x) Clinical Trials

Under the Horizon 2020 research program of the European Union, we are coordinating PROFID, a large international research project on prediction and prevention of sudden cardiac death after myocardial infarction. www.profid-project.eu The project is financed exclusively by a large grant of the European Union. It started in January 2020, is scheduled for five years and brings together more than 20 top partners from 12 European countries including key academic institutions, the European Society of Cardiology, public health insurance, health economic experts, and patient organizations. The assessment of risk factors for sudden cardiac death is based on machine learning approach upon approx. 1 million patient datasets. The findings will be subsequently validated in two international clinical trials that are currently the worldwide largest clinical trials in the field of cardiac devices. A project description has been provided in the European Heart Journal.

  • Overall responsibility for the two PROFID trials, supervision and ensuring proper trial conduction
  • Coordination and management of the clinical trials in accordance with the respective international guidelines, applicable national legislation, and standard operating procedures with a focus on EU countries
  • Close cooperation with the contract research organization and support with study preparation and preparation of the approval documents
  • Subcontracting with the clinical sites
  • Control and assurance of the legal and GCP-compliant implementation of the trials
  • Control of the project status, in particular adherence to the schedule
  • Contract preparation under the regulatory and academic framework of international clinical research
  • Ensuring compliance with project timelines, quality standards and goals of the trials
  • Communication with international partners and the European Union on a regular basis
  • University degree in medical, pharmaceutical or life science subject, PhD preferred
  • Significant experience (minimum of three years) in the management of clinical trials and the requirements of public funding
  • Demonstrated skills in the management of projects with experience in prioritizing tasks with effective organization and planning
  • Basic knowledge of data management, biometrics and statistics
  • Delight in international cooperation
  • Sociable personality and professionalism, thorough and reliable
  • Candidate must be fluent in English (oral and written comprehension is required)
  • Ability to effectively communicate with the regulatory agencies as well as internal staff
  • Excellent proficiency in MS Office (i.e., Word, Excel, PowerPoint) and knowledge in current applications and online portals related to regulatory activities
  • You work in a leading research unit next to the Heart Center Leipzig, one of the biggest research centers for cardiovascular diseases worldwide.
  • Growth and learning – Get access to journas, scientific ressources, courses and more, via the Helios Learning Plattform.
  • Work-family-friends balance – we listen to our employees’ individual needs and respect their personal time.
  • We offer free gym in our premises, company events, Helios Plus Card (free) and Job-Ticket for your transportation.

Now it’s your turn!

Please apply with an English CV/resume (incl. your salary expectations) to:

Leipzig Heart Institute GmbH

Maria Gur Arie

Project Manager PROFID

maria.gurarie@leipzig-heart.de

The Leipzig Heart Institute GmbH and the Leipzig Heart Science gGmbH are the research platform of the Heart Center Leipzig, one of the largest heart centers in Europe focusing on treatment of the whole spectrum of cardiovascular diseases. Together, we have a worldwide reputation in cardiovascular research for better understanding of heart function and disease and the development of new or better treatments. 

  • Career level:
  • Professional Experienced
  • Job function:
  • Research
  • Working condition:
  • Permanent / Full-time
  • Business segment:
  • Fresenius Helios
  • Location:
  • Sachsen / Leipzig
  • Closing date for applications:
  • none - we look forward to your application
Maria Gur Arie
Leipzig Heart Institute GmbH
Ref. number 42771

We welcome diversity

At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics.

All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse).

Career with a purpose

Over 300,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.

Project Manager (m/f/x) Clinical Trials

Under the Horizon 2020 research program of the European Union, we are coordinating PROFID, a large international research project on prediction and prevention of sudden cardiac death after myocardial infarction. www.profid-project.eu The project is financed exclusively by a large grant of the European Union. It started in January 2020, is scheduled for five years and brings together more than 20 top partners from 12 European countries including key academic institutions, the European Society of Cardiology, public health insurance, health economic experts, and patient organizations. The assessment of risk factors for sudden cardiac death is based on machine learning approach upon approx. 1 million patient datasets. The findings will be subsequently validated in two international clinical trials that are currently the worldwide largest clinical trials in the field of cardiac devices. A project description has been provided in the European Heart Journal.

Your assignments

  • Overall responsibility for the two PROFID trials, supervision and ensuring proper trial conduction
  • Coordination and management of the clinical trials in accordance with the respective international guidelines, applicable national legislation, and standard operating procedures with a focus on EU countries
  • Close cooperation with the contract research organization and support with study preparation and preparation of the approval documents
  • Subcontracting with the clinical sites
  • Control and assurance of the legal and GCP-compliant implementation of the trials
  • Control of the project status, in particular adherence to the schedule
  • Contract preparation under the regulatory and academic framework of international clinical research
  • Ensuring compliance with project timelines, quality standards and goals of the trials
  • Communication with international partners and the European Union on a regular basis

Your profile

  • University degree in medical, pharmaceutical or life science subject, PhD preferred
  • Significant experience (minimum of three years) in the management of clinical trials and the requirements of public funding
  • Demonstrated skills in the management of projects with experience in prioritizing tasks with effective organization and planning
  • Basic knowledge of data management, biometrics and statistics
  • Delight in international cooperation
  • Sociable personality and professionalism, thorough and reliable
  • Candidate must be fluent in English (oral and written comprehension is required)
  • Ability to effectively communicate with the regulatory agencies as well as internal staff
  • Excellent proficiency in MS Office (i.e., Word, Excel, PowerPoint) and knowledge in current applications and online portals related to regulatory activities

Our offer to you

  • You work in a leading research unit next to the Heart Center Leipzig, one of the biggest research centers for cardiovascular diseases worldwide.
  • Growth and learning – Get access to journas, scientific ressources, courses and more, via the Helios Learning Plattform.
  • Work-family-friends balance – we listen to our employees’ individual needs and respect their personal time.
  • We offer free gym in our premises, company events, Helios Plus Card (free) and Job-Ticket for your transportation.

Now it’s your turn!

Please apply with an English CV/resume (incl. your salary expectations) to:

Leipzig Heart Institute GmbH

Maria Gur Arie

Project Manager PROFID

maria.gurarie@leipzig-heart.de

The Leipzig Heart Institute GmbH and the Leipzig Heart Science gGmbH are the research platform of the Heart Center Leipzig, one of the largest heart centers in Europe focusing on treatment of the whole spectrum of cardiovascular diseases. Together, we have a worldwide reputation in cardiovascular research for better understanding of heart function and disease and the development of new or better treatments. 

Your contact

Maria Gur Arie
Leipzig Heart Institute GmbH
Ref. number 42771

Career level
Professional Experienced
Job function
Research
Working condition
Permanent / Full-time
Business segment
Fresenius Helios
Location
Sachsen / Leipzig
Closing date for applications
none - we look forward to your application

We welcome diversity

At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics.

All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse).

Career with a purpose

Over 300,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.

You might be interested in these jobs