TMF Associate (Contract) | BioNJ Talent Services

TMF Associate (Contract)

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHARTâ„¢) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

Position Summary

The TMF Associate is responsible for the day-to-day activities associated with filing in the TMF room as well as filing in the electronic TMF for all studies at Amicus. The TMF Associate supports the operational teams at Amicus. Works closely with the CTAs and CRAs. This role is entry level and an opportunity for someone with very little experience to get into clinical research.

Roles and Responsibilities
Files documentation in the TMF room for all Amicus studies
Scans and sends files to the electronic TMF at CROs as requested by CTM, CRA or CTA
Maintains orderly files in the TMF room on all studies, old and new
Maintains inventory logs for all studies
Pulls files from the TMF room as requested

Qualifications: 

Requirements
BA/BS required
Some knowledge of Clinical studies is helpful

Experience and Skills
Good organizational skills
Strong communication skills, both written and verbal
Experience with Microsoft Word, PowerPoint, and Excel

Travel
0-5%

Additional Job or Internship Information
Position Type: 
Contract
Function: 
Clinical Operations