What are the responsibilities and job description for the TMF Specialist position at Actalent?
Description:
• People o Ability to collaborate with internal and external teams on projects and deliverables o Experience training users on eTMF systems • Process o Experience with DIA Reference Model o Extensive knowledge of TMF clinical documentation o Run and perform review of reports and dashboards within eTMF to track and maintain eTMF health o Conduct quality checks on study rooms o Work with study teams to resolve outstanding items o Filing and/or archiving paper and electronic records o Serve as back-up Administrator for eTMF system o Facilitate requests for information o Assist with oversight of eTMF vendor o Serve as SME on TMF document management process • Systems o Experience working with eTMF systems (Veeva, Trial Interactive, etc.) Key activities: Trial Master File DIA TMF Reference Model Clinical document management Electronic trial master file Trial Interactive eTMF (preferred) Veeva eTMF
Skills:
Etmf, Veeva, Document management, TMF, trial interactive
Top Skills Details:
Etmf,Veeva,Document management,TMF
Additional Skills & Qualifications:
o 5 years’ experience minimum o Bachelor’s degree required o Attention to detail o Admin for eTMF system o Experience working with global teams o Knowledge of CFR Title 21 and ICH GCP guidelines o Strong communication skills
Experience Level:
Entry Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $40 - $50
