Clinical Project Leader

Publicado el 26 de octubre, 2024

Metropolitana de Santiago,

Mixto

Jornada Completa

$ NO INDICADO

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Descripción del Puesto

The Local Study Manager (Generic role for Clinical Project Leader) is responsible to:
Coordinate and supervise the clinical trial develop, relevant to the position.
Ensure quality standards compliance in clinical studies in hisher charge.
To be the link between the international Clinical Sciences Operations and the CSU (within framework of clinical trials).

Main responsibilities:
MAIN SUPERVISED RESOURCE
Reports of drugs in research phases of Clinical Research Protocols.
Budgets.
Audits and inspections.
Clinical trials monitoring documentation.

MAJOR RESPONSIBILITIES & FINALITIES
Participate in the feasibility evaluation of carrying out a study in the country and the investigators selection.
Prepare the country´s study budget and prepare investigator´s contracts when requested.
Provide the necessary documentation to submit to the ethics committee, to the HA and other regulatory entities.
Ensure that sites are initiated and monitored properly.
Ensure and supervise that investigator are fully informed of the organization, the study and of local and international regulations.
Participate in local international audits and inspections.
Train and coordinate the activities of the monitors.
Following up the study files, ensuring that all supporting documentation is available.

CONTACTS WITH OTHERs
Inside the company:Medical Directorate.
Export-Supply Chain.
Warehouse Depot.

Outside the company:Distributors.
Research Sites.
Ethics Committees.
HA.

MAJOR CHALLENGES OF THE POSITION
To achieve that investigators maintain optimum quality and performance.
To maintain orderly and up to date study documentation.
Organize work teams to ensure and effective result.

About you
PROFESSIONAL EXPERIENCE
Training in Medical Science (Biologist, Biochemistry, Medical, etc).
Experience in clinical research.
Experience in monitoring, audits & inspections.

MAJOR SKILLS AND COMPETENCES
Ability to manage high volumes of work.
Communication skills and good interpersonal relationships.
ADVANCED Written and spoken English
Availability to travel.

Better is out there. Better medications, better outcomes, better science. But progress doesnt happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, lets be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.
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.
About Us

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our We Are Sanofi movie 
Why Sanofi

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
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Requisitos del Puesto

Educación Requerida: Secundario
Edad: 18 años mínimo
Experiencia Requerida: 1 año en puestos similares
Disponibilidad para viajar: No
Disponibilidad para mudarse: No

Aviso Importante: Este aviso fue redactado y es administrado por el anunciante, por lo cual nuestra empresa no se hace responsable por su contenido.