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SalaryAbout 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.
The Trial Master File Associate is responsible for creating, organizing, maintaining, and overseeing the Trial Master File (TMF)
As part of our TMF Delivery team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
Key Responsibilities
- Create the study TMF Index as directed by the PM
- Create the first draft of the TMF Plan, implement changes after review, generate final version and distribute final version to the study team
- For electronic TMF, the TMFa is requested to initiate with IT the eTMF at trial, country and site level
- Notify study team that TMF is created and ready for document submission
- Actively follow up that the study team is submitting documentation, following the process described in The TMF Plan and that the TMF is submission and inspection ready at all times
- Provides support and training to study team in regard to the TMF workflow and management
- Act as contact person for study team to support on all TMF issues/inquiries
- Identify areas with missing documentation and inconsistencies and follow up with the study team for resolution
Qualifications
- Bachelor’s Degree or equivalent work experience is preferred
- Knowledge of GCP/ICH guidelines
- Good 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
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 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven 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 cores values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making 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 unifed 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.
