Trial Master File Associate

TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full servicecapabilities resourcing and Functional Service (FSP) solutions.

Join Our Team as a Trial Master File Associate (TMF Associate) home based in Poland.

About this role

TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full servicecapabilities 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 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.

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:

Bachelors Degree preferred Knowledge of GCP/ICH guidelines

Good English written and communication skills

Good organizational and multitasking 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. Youll 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 27 years ago in Sweden in the city of Lund. As a fullservice global Contract Research Organization (CRO) we build solutiondriven teams working towards a healthier future. Bringing together over 800 professionals TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.

Our core values of Trust Quality Passion Flexibility and Sustainability are our guiding light serving as the framework for decisionmaking at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments resulting in high employee engagement and satisfaction. By aligning on these fundamental values we cultivate a unified force geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.