Massachusetts Veterans Jobs

Description:

• Main role would be to clean up a couple TMFs; furthermore, needs to bring the TMF to inspection readiness.

• Must be able to identify what's missing and file it in the TMF.

• Confirm questions with the study team and work with the CRO

• Work with multi-functional teams (internal and external) to ensure the maintenance and readiness of TMFs.

• Tracks effective and expiration dates of external documents (e.g., clinical laboratory certifications, Medical Licenses, and curriculum vitae (CVs)).

• Collects, reviews, and indexes essential documents in accordance with TMF structure.

• Uploads TMF documents and/or other document files, e.g., as “working documents” while the study is ongoing.

• Acts as TMF Subject Matter Expert (SME) and point-of-contact for study teams and TMF stakeholders.

• Performs other tasks and assignments as needed and specified by management.

Skills:

Etmf, Trial Interactive, Clinical trial

Top Skills Details:

Etmf,TI,Clinical trial

Additional Skills & Qualifications:

-Experience with is a plus but not a must have

-Proficiency and at least 3 years of experience using TI/Veeva TMF & CTMS preferred.

-Knowledge of FDA regulatory requirements and ICH/GCP guidelines

-Demonstrated efficiency in partnering with CROs and vendors.

-Work proactively and efficiently in a fast-paced, high change environment

-Excellent written and oral communication skills

-Outstanding organization skills

Experience Level:

Expert Level

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.