Country Study Specialist Support

Descripción de la oferta

  Job facts

A role based in a Clinical Operations Department, reporting to the Local Vendor and SupportManager. The Country Study Specialist (CSS) is responsible for providing operationalsolutions to support Country Study Managers/Gerente de Investigación Clínica (CSMs) and toprovide oversight to local study teams to enable effective management of both global andlocal studies.

Major responsibilities include:

·  Supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring Roche quality and safety standards, regulations, timelines and budget commitments are met.
·  Provides input into and/or develops study related materials such as Monitoring Plans. Recruitment Plans and Study Newsletters.

·  Maintains effective and ongoing communication with CSM; supports communication with local study teams and to sites as required.

·  Works with global study team and CSM to support the day-to- day activities of the study, including monitoring report review, problem solving, issue escalation, timely closure of non-productive sites and tracking of safety procedures.

·  Supports management of country-level Trial Master File (TMF) and reviews for quality. Ensures accurate translation of all documents, as applicable.

·  Supports the CSM for local affiliate study level audit / inspection audit action plan activities.

·  Coordinates study or country communication plan.

·  Who we are

En Roche, nuestro éxito se basa en la innovación, la curiosidad y la diversidad, multiplicado por 91,700 profesionales en 100 países. Trabajando juntos, nos hemos convertido en uno de los grupos líderes de salud enfocados en la investigación.

Roche es un empleado que ofrece igualdad de oportunidades

Perfil buscado

Who you are

Si eres una persona que controla su propio desarrollo. Si buscas una empresa en donde tengas la oportunidad de conseguir tus metas más allá de tus funciones y ubicación. Donde un puesto de trabajo no se considere la definición final de quién eres, sino el punto de partida, ven a trabajar con nosotros.

Requirements:

·  University Degree in a medical/science-related field
·  Postgraduate education will be highly valued (Master Degree, Specialization)

·  Minimum 2-3 years; work experience demonstrating knowledge and understanding of clinical studies.
·  Extensive knowledge of ICH/GCP; GPP guidelines knowledge highly valuable.
·  Prior work experience demonstrating knowledge and understanding of clinical studies.
·  Able to prioritize and manage multiple tasks with high flexibility.

·  Proven project management skills to work with a variety of different systems and stakeholders and deliver commitments on time and with quality.
·  Self-motivated and displays initiative/resourcefulness.

·  Ability to work independently with limited supervision.

·  Strong attention to detail.

·  Ability to communicate clearly and accurately in both written and spoken English.

·  Demonstrated computer literacy, advanced usage of MS Office software, and web-based systems and databases.

Competencies profile:

·  Managing Work
·  Monitoring Information
·  Communication
·  Work Standards
·  Adaptability
·