Salary: Not specified
Job Description:
The Associate II, TMF Operations role is responsible for managing essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices. This global position requires collaboration with Worldwide Project Team members to ensure the management of essential documents.
This includes processing, maintaining, and archiving all necessary documents in electronic and hard copy formats. The Associate will also perform periodic Quality Control checks to ensure adherence to regulatory requirements, ICH GCP, Sponsor, and industry best practices.
Main Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolios of studies in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Lead to report trends and issues related to the TMF.
* Elevate any TMF Quality issues in a timely manner to RMC Lead.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
Key Skills and Qualifications:
* Proficiency in using an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in fast-paced, deadline-oriented, rapidly changing environments.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Requirements:
* University Degree preferred, Life Science desirable.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry desirable.
Key Requirements:
Required Skills:
- Proficiency in electronic document repository or eTMF
- Strong communication skills
- Ability to work in a fast-paced environment
Preferred Skills:
- University Degree, Life Science desirable
- 1-2 years of relevant experience
Working Conditions:
- Global role
What You Will Do:
As an Associate II, TMF Operations, you will be responsible for ensuring the accuracy and completeness of trial master files in compliance with regulatory requirements. This involves reviewing, classifying, and processing essential documents, as well as communicating with project team members and escalating any quality issues.
You will also provide administrative support to the RMC Lead, including filing and maintaining internal documents on study SharePoint. Additionally, you will participate in periodic quality control checks to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
Your expertise in electronic document management systems, combined with your strong interpersonal skills, will enable you to effectively collaborate with colleagues and communicate complex information in a clear and concise manner.
Ultimately, your goal will be to contribute to the success of the team by ensuring the accurate and efficient management of trial master files.
Why It's Important:
In this role, you will play a critical part in ensuring the integrity and quality of trial master files. Your attention to detail, organizational skills, and ability to work effectively in a team environment will make a significant contribution to the success of the organization.
How We Work:
We operate in a fast-paced, dynamic environment where innovation and collaboration are key. Our teams are dedicated to delivering high-quality results while maintaining a focus on customer satisfaction.
Our employees enjoy a range of benefits, including opportunities for professional development, flexible working arrangements, and a supportive team environment.
Join Our Team:
If you're looking for a challenging and rewarding role where you can apply your skills and experience to make a real difference, we encourage you to apply.