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Tmf Associate

hace 2 semanas

Barcelona, España TFS HealthScience A tiempo completo

**Join Our Team as a TMF Associate**

**About this role**

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
- As part of our _**_Clinical Operations Unit_**_ team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals._

The **TMF Associate** is part of the Clinical Operations Unit within TFS Clinical Development Services (CDS) and will function operationally as a member of the Study Team with the responsibility to create, organize, maintain and oversee the Trial Master File (TMF) according to company policies, SOPs, Work Instructions and regulatory requirements.

**Key Responsibilities**
- Create the Study TMF Index as directed by the PM (Project Manager)
- Create first draft of TMF Plan, implement changes after review, generate final version and distribute final version to the study team
- Create TMF at Trial, Country and Site Level (paper TMF)
- Request IT to create eTMF at Trial, Country and Site Level when TFS system is used
- Inform to study team that TMF is created and ready for document submission
- Actively follow up study team is submitting documentation following the process described in The TMF Plan
- Actively collaborates in the training to study Team in regards to the TMF workflow and management

**Qualifications**:

- Bachelor’s Degree preferred
- Knowledge of GCP/ICH guidelines
- Good English - written and communication skills
- Good organizational and multi-tasking skills
- Good software and computer skills
- Able to work in a fast paced environment with changing priorities
- Able to effectively work in a team environment
- Effective time management

**What We Offer**:
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

**A Bit More About Us**:
Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.

**#Together we make a difference