Clinical Study Manager (f/m/d) en Barcelona

Descripción del empleo

About Us

: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates. About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore.com/products/industries. About the Role:  We are looking for a Clinical Study Manager (f/m/d) to join our EMEA team in Spain or the Netherlands who will design, plan, implement, and manage the overall conduct, or particular elements, of clinical research projects. This role offers the opportunity to work from a remote office or from our facility in Barcelona, Spain. In this role you will ensure compliance with the protocol and overall clinical objectives as well as applicable Standard Operating Procedures and regulations. Responsibilities:

Coordinating the activities of interdisciplinary Gore team members in the planning, executing and closing of clinical studies

Developing and approving study-specific documents, tools, presentations and processes

Delivering study related training

Preparing and presenting at Investigator meetings

Participating in the site qualification, study initiation and study closure process

Assisting with the management of medical device distribution, receipt, use and return

Tracking and reporting progress of studies to applicable internal stakeholders including: patient screening, enrollment, data collection, adverse event documentation and reporting

Developing Study Reports and providing clinical portions for Regulatory submissions

Overseeing activities of site monitors, including reviewing and approving visit reports

Maintaining familiarity with all applicable regulatory requirements and relevant clinical literature

Required Qualifications:

Bachelor’s degree in science/health related field or nursing degree

At least 3 years of experience in performing clinical studies

Computer literacy (e.g. Outlook, Word, Excel, PowerPoint)

Organizational skills, flexibility, and ability to multi-task

Fluent in English, any other European language is a plus

Experience working on cross-functional teams

Up to 25% travel might be required

To help us fill this position we are collaborating with our external recruitment agency Elemed. This means your application will be shared with them, and they might then respond to you directly.

Información extra

Status

Inactiva

Estudios requeridos

Otros

Localización

Barcelona

Horas a la semana

8 - 40

Tipo de contrato

Tiempo completo

Tipo de trabajo

Marketing / Publicidad

Carnet de conducir

No

Vehículo

No

Carta de motivación

No

Idiomas

Inglés