Talentify.io · 4 days ago
Tmf Specialist REMOTE
United States
Full-time
Remote
Mid Level
3+ years exp
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Responsibilities
Clean up and prepare Trial Master Files (TMFs) for inspection readiness
Identify and file missing documents in the TMF in collaboration with the study team
Confirm questions and resolve issues with the study team and Contract Research Organizations (CROs)
Maintain compliance with FDA regulatory requirements and ICH/GCP guidelines
Partner efficiently with CROs and vendors to facilitate study progress
Qualification
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Required
Minimum of 3 years of experience using TI/Veeva TMF & CTMS
Knowledge of FDA regulatory requirements and ICH/GCP guidelines
Excellent written and oral communication skills
Outstanding organizational skills
Ability to work proactively and efficiently in a dynamic environment
Preferred
Experience with TI is a plus but not mandatory
Demonstrated efficiency in partnering with CROs and vendors
Company
Talentify.io
Talentify.io exist to conceive and develop solutions that enable organizational leaders to cultivate a great work environment.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.5MKey Investors
Cielo Talent
2018-01-11Corporate Round· undefined
2015-05-05Pre Seed· $0.5M
Leadership Team
Othamar Gama Filho
Co-Founder & CEO
Company data provided by crunchbase
