Description TFS HealthScience is a Global CRO headquartered in Sweden. We genuinely believe that "Global in mind and local at heart" is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory...
Description

TFS HealthScience is a Global CRO headquartered in Sweden. We genuinely believe that "Global in mind and local at heart" is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.

Project Related
  • Active participation in the preparation of Clinical Development plans
  • Collaboration in the elaboration and review of clinical trials outlines, DSUR, IB, and international (Europe/FDA) submission dossiers.
  • Participation and reporting to the Project Team (PT), Medical SubTeam (MST), Core Teams and, any other team as needed.
  • Participation in advisors, partners or in- and out-licences meetings, including the preparation and review of associated documentation.
  • Collaborate in the creation of presentations for congresses and/or papers for medical journals based on CT results.
  • Planning and conduct of clinical trials/experimental and cosmetic testing/investigations with medical devices, including preparation, review or approval of all associated documentation (synopsis, protocol, report, timelines, all study plans -statistical, data management, monitoring,...-, technical specifications, IMP related documents, and any other study-related documentation) and management of study budget, including approval of invoices payment and forecast planning.
  • CRO and other vendors selection for the outsourcing of Clinical Trials and other activities task according to Project needs.
  • Leadership and coordination of the different areas and activities of the “Clinical Study Team”(CST), and organisation of periodic meetings.
  • Cooperation with other department representatives when needed
  • Participate in the preparation of any documentation related to competent national and local authorities, and the relevant ethics committees, coordinate and boost regulatory submissions and answer to their questions.
  • Organize and/or participate in the Investigators Meeting/Pre-initiation visits/Kick-off Meetings presenting the protocol and study operational aspects (study drug, monitoring) of the study, and visit research sites ad-hoc
  • Supervise and boost sites activation and recruitment progress, database cleaning, and timely SAE reporting.
  • Review of the Trial Master File key documents related to activities under CTM direct responsibility
  • Collaboration in the planning and conduction of audits and CAPA implementation, and in the inspections to the participating sites or sponsor.
  • Ongoing review of CT blinded data (e.g. for identification of protocol deviations, ensuring accuracy of data cleaning, early detection of unexpected trends on patients baseline characteristics).
  • Leadership of the “Blind Data Review Meeting”.
  • Ensuring the CT are conducted in accordance with Good Clinical Practices (GCPs) , with applicable international quality standards, with the agreed (CRO) SOPs, policies and standards, as well as any other guidelines given by the Head of Global Clinical Operations (GCO) and GCL.
  • Report and discuss with the Medical subteam Escalation to the GCL and/or Project Manager and Head of GCO any significant deviation (or a risk for deviation).
  • Continuing education and training on medical and clinical research topics. Assistance to courses, congresses, trainings, investigator’s meetings, specialised journals reading, international conferences, etc.
  • Collaboration in SOPs update/creation/training.
Requirements
  • Graduate in Health Sciences (Pharmacy, Biology, Biochemistry and/or Medicine and Surgery).
  • Participation in Clinical Trials
  • Pharmaceutical Industry business
  • Project Management
  • Basic Statistics and/or Biometry
  • Basic Pharmacokinetics, Clinical Toxicology and Pharmacology
  • Others: Preferably Doctor’s degree
  • English essential
  • Other languages desirable
  • Communication and Negotiation skills
  • Previous Experience in the role
Experience

Mid-Senior level

¡No te pierdas nada!

Únete a la comunidad de wijobs y recibe por email las mejores ofertas de empleo


Nunca compartiremos tu email con nadie y no te vamos a enviar spam

Suscríbete Ahora

Últimas ofertas de empleo de Jefe/a de Proyectos en Barcelona

Clubs de Fitness DIR

Barcelona, ES

¿Te gustaría hacer realidad tu sueño y formar parte de la mejor empresa de fitness? ¡En DiR tenemos ganas de recibirte...

SIDN Digital Thinking

En SIDN Digital Thinking te queremos ¿Eres una persona apasionada del marketing digital y de la gestión de proyectos?...

Michael Page

Barcelona, ES

Perfil buscado (Hombre/Mujer) • Definición y soporte de una plataforma de APIs que permita la exposición de APIs para...

Michael Page

Barcelona, ES

Perfil buscado (Hombre/Mujer) • Manage end-to-end projects, from initiation to closure, ensuring they are delivered on...

Project Manager

23 mar.

LAINCO agro

Font-rubí, ES

We are seeking a dynamic and highly skilled Project Manager to join our team. In this role, you will be responsible for...

Gestelcom Servicios

Barcelona, ES

Gestelcom Servicios, empresa de servicios de telecomunicaciones, busca un Gestor de Proyectos de Telecomunicaciones.

Revo | Part of [Strategic Platform]

[Strategic Platform] nace de la alianza entre REVO (consultoría estratégica) y ENZYME (consultoría tecnológica).

PROJECT MANAGER

21 mar.

Keeway motor españa

Sant Quirze del Vallès, ES

Requisitos del puesto de trabajo Formación: Graduado en Ingeniería Industrial, mecánica o de Diseño industrial.

Michael Page

Barcelona, ES

Perfil buscado (Hombre/Mujer) • Identificar y diseñar la infraestructura tecnológica de la compañía, de acuerdo con las...

Project Manager

20 mar.

COLUMNA BRANDING, S.A.

Barcelona, ES

Columna es una agencia de branding que ayuda a las marcas inquietas a conectar con las personas y estamos en la búsqueda...