Location
Boston, MA | United States
Job description
Responsibilities :
The TMF/CTMS Specialist will work with the Manager, Clinical Operations & team to support the Veeva TMF/CTMS. The TMF/CTMS Specialist will partner with the Study teams to ensure that the Veeva TMF & CTMS are following SOPs, FDA regulations and ICH/GCP guidelines.
- Work with Manager, Clinical Operations to update and maintain Veeva TMF & CTMS Job Aid
- Assist with UAT of newly configured changes in Veeva TMF & CTMS
- Update auto naming convention tracker with approved end user changes and requests
- Assist with the creation of a Quarterly QC and TMF Readiness process and assist with the rollout to end users.
- Notify end users on Quarterly Veeva Releases and inform vendors on any impactful changes to the Veeva functionality.
- Create a test study in Veeva Sandbox to ensure that the functionality and permissions align with SOPs, Job Aid and training documents and identify any issues with the functionality or permissions.
- Work with CTAs and Vendors to ensure Functional Areas are uploading their documents into Veeva in a timely manner and help streamline process.
- Upload backlog of documents into the Compassionate Use Study
Minimum Requirements: - Three or more years’ experience in clinical operations
- Proficiency and at least 3 years of experience using Veeva TMF & CTMS preferred.
- Knowledge of FDA regulatory requirements and ICH/GCP guidelines and the DIA Reference Model
- Work proactively and efficiently in a fast-paced, high change environment
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email
[email protected] for other accommodation options.
Job tags
Salary