Job Description
We are seeking a skilled Associate II to join our team in TMF Operations. The successful candidate will be responsible for the processing, maintaining and archiving of all essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practice.
The role requires strong interpersonal skills in a fast-paced, deadline oriented environment and the ability to work independently with minimal supervision.
* Process, review, and resolve rejected Trial Master File (TMF) documents in both electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Work with Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
The ideal candidate will have proficiency in use of an electronic document repository or eTMF, document recognition skills, and strong analytical skills. Additionally, they should possess a university degree preferred in Life Science and 1-2 years of relevant experience.
Main Responsibilities:
* TMF Documentation: Process, review, and resolve rejected Trial Master File documents.
* TMF Quality Control: Perform periodic quality control checks to ensure adherence to regulatory requirements.
* Document Management: Work with Electronic Document Management and electronic TMF Systems to manage essential documents.
* Communication: Communicate directly with RMC Lead to report trends and issues.
Requirements:
* Proficiency in electronic document management systems.
* Strong analytical and problem-solving skills.
* Excellent communication and interpersonal skills.
* University degree preferred in Life Science.
* 1-2 years of relevant experience.
About the Role:
This is a global role requiring collaboration with Worldwide Project Team members. The successful candidate will support the delivery of department objectives by ensuring the management of essential documents in compliance with relevant regulations and industry best practices.