CSU Medical Advisor & Clinical Project Leader
Genzyme
Athens
πριν από 2 μέρες

LI-EUR

CSU Medical Advisor & Clinical Project Leader

About the Opportunity

The Medical Advisor (MDA) is the Medical and Scientific reference point within the Clinical Study Unit (CSU) for scientific training and advice of the operational team, and for the scientific supervision of clinical studies.

The CSU Medical Advisor holds primary responsibility for the clinical studies feasibility assessment and protocol design optimization.

He / she is the scientific liaison among the Global Clinical Study Director, the CSU team and the Investigators for the protocol optimization and for all clinical aspects related to the Clinical Studies.

He / she is working with the respective Medical colleagues at Cluster level and affiliate level, according to the therapeutic areas and the new compounds under development, with a view to optimizing and increasing involvement in international or local clinical studies at GR / CY sites.

The Clinical Project Leader (CPL) is responsible for the set up and progress of a clinical trial / observational study / special program in his / her own country or in the assigned countries in the Adriatic Cluster, ensuring compliance with Sanofi Group quality standards and regulations in force, the forecasted timelines, milestones and budget.

About Sanofi Business Unit

As people live longer, chronic conditions are on the rise. New viruses and diseases are emerging while old enemies like cancer and neurodegenerative diseases remain.

Sanofi is driven by the scope of these health challenges.

As researchers, we’re passionate about scientific excellence because we know that what we do today may improve the lives of people tomorrow.

We work to transform scientific knowledge and medical advances into cutting-edge therapies for patients. Discovering solutions to the world’s most pressing unmet medical needs is our top priority and inspires us to be the best possible health journey partner for patients.

Sanofi’s R&D community is made up of scientists, physicians, technicians, product and manufacturing engineers and many others who contribute to our scientific leadership.

Our goal is breakthrough innovation that can transform, extend and potentially save lives. At the end of July 2018, the R&D pipeline contained 87 projects including 40 new molecular entities in clinical development.

A large number of projects are in phase 3 or have been submitted to the regulatory authorities for approval.

As a Medical Advisor :

  • To develop and maintain relationships with Key Opinion Leaders and representatives of the medical society, in order to identify and propose the most suitable pool of investigators to participate in future studies;
  • To ensure, in collaboration with other stakeholders, that CSU personnel are kept up with any new scientific information;
  • To support the Monitoring Team in tackling issues of a medical / scientific nature connected with study protocols in the area of competence;
  • To lead / coordinate feasibility process for future studies. More specifically to evaluate during feasibility potential implementation of protocol in Greek and or Cypriot sites, by interacting both with investigators chosen among expert and reliable trialists and with respective Medical Advisors within the Cluster or locally with Medical Affairs;
  • Based on an international clinical program, to identify the areas and the new therapeutic indications in which the CSU’s expertise needs strengthening preparing at the same time a plan of implementation.
  • As a Clinical Project Leader :

  • Is accountable for set-up and progress of the study according to the company standards and regulation in force and ensures that committed targets and timelines are met at all steps and until study completion;
  • To collaborate with the local Medical Advisor to identify potential investigators;
  • To ensure high quality management of the study;
  • To lead the monitoring team in the country;
  • To ensure liaison with other local team members and with the study team at global study management level.
  • Essential requirements :

  • Educational background in Medicine with specialization (preferably) or equivalent expertise in one of the following fields : Internal Medicine, Rare diseases, Pulmonology, Immuno-
  • Inflammation, Oncology or Neurology;
  • At least 5 years in clinical research operations area;
  • Experience as Clinical Project Leader (with preference for oncology therapeutic area and immunology) will be of added value;
  • Knowledge of GCP / ICH phase I-IV clinical trials and observational studies;
  • Strong Clinical Project Management skills needed to effectively manage a large number of trials in different therapeutic areas and in different countries;
  • Strong motivation to high performance;
  • Knowledge of the current trends in clinical trials risk based approach and digital technology;
  • Deep knowledge of quality issues management and FDA / EMA requirements for inspection readiness;
  • Strong leadership and excellent interpersonal and communication skills including a good customer focus mentality;
  • High organizational, analytical and planning abilities, proactivity and ability to anticipate and resolve conflicts / issues, reactivity to emergent needs, ability to prioritize, time management;
  • Team working ability to guarantee activity respecting ethics, quality and compliance with applicable legislation and Guidelines;
  • Good IT skills are essential, for planning, tracking, communicating and reporting;
  • Strong English language skills;
  • Greek Language skills fluent.
  • Empower Life Everyday

    At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career.

    Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.

    Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world.

    Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems.

    We want to focus on those areas where we know we are making a difference.

    The values we are live by are teamwork, courage, respect and integrity.

    At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.

    We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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