About the Role
The Associate II, TMF Operations is responsible for processing, maintaining and archiving essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practices. This global role requires working with project team members to ensure management of essential documents.
* Process, review and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats for complex studies or sponsor portfolios.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, sponsor and industry best practices.
* Review, classify and process Essential Documents using Electronic Document Management and electronic TMF Systems.
* Communicate trends and issues related to the TMF with the RMC Lead and escalate quality issues in a timely manner.
* Provide administrative support for the RMC Lead including filing and maintaining internal documents on study SharePoint.
Key Responsibilities
The successful candidate will be responsible for:
* Proficiency in use of an electronic document repository or eTMF and document recognition skills.
* Strong interpersonal skills in a fast-paced, deadline-oriented environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Requirements
To be considered for this role, candidates should have:
* University degree preferred, Life Science desirable.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry desirable.
About You
Candidates should possess strong analytical and problem-solving skills, excellent communication and teamwork abilities, and a keen eye for detail. They should also be proficient in software applications such as Microsoft Office and electronic document management systems.