TMF Associate
TMF Associate
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1 Vacancy
Job Description
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.
The Trial Master File Associate is responsible forcreating organizing maintaining and overseeing the Trial Master File (TMF)
As part of our TMF Deliveryteam 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
- Bachelors Degree or equivalent work experience is preferred
- Knowledge of GCP/ICH guidelines
- Good written and communication skills
- Good organizational and multitasking skills
- Good software and computer skills
- Able to work in a fastpaced 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. 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 cores 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 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.
Employment Type
Full Time
