Trial Master File Associate

Overview

TFS HealthScience is excited to be expanding our

**Clinical Operations Unit** and we are looking for an experienced, highly motivated

**Trial Master File Associate (TMF Associate) **who shares our vision of providing clinical research excellence. Our

**Clinical Operations Unit** is a highly experienced international group of professionals led by an industry expert.

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.

Our cores values of Trust, Quality, Flexibility and Passion are what makes 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 organisation.

**Together we make a difference.**

TFS HealthScience is looking for a

**Trial Master File Associate (TMF Associate) to work hybrid in Barcelona**

**.**

**What can we offer you?**

A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.

**Spain**

**benefits include**

• Private Health Insurance
• Global General Liability Insurance
• Global Travel Insurance
• Lunch Allowance
• Homebased Allowance for home-based employees
• Pre-tax scheme for employees who use the nursery ticket system
• Flexible working schedule - which encourages a balanced work and home life

**Responsibilities**

The

** Trial Master File Associate (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.

• 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
• TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the _
• privacy notice_
• for further details._
• TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits._