Senior TMF Associate at Fortrea

Mumbai, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

11 Jan, 26

Salary

0.0

Posted On

13 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Document Classification, eTMF Management, Regulatory Requirements, Quality Checks, Audit Readiness, GCP Guidelines, ICH Guidelines, Microsoft Office, Adobe Acrobat, Interpersonal Skills, Training, Mentoring, Business Improvement, Clinical Research, Operational Issue Resolution, Client Satisfaction

Industry

Biotechnology Research

Description

Job Overview:Manages the document classification under Smart Inbox and ARC review (as applicable) as well as document deletion. Summary of Responsibilities:•Maintains an understanding of applicable regulatory requirements.•Managing electronic Trial Master Files (eTMF), (Trial, Country, and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Study Team Member -•Responsible for document classification under Smart Inbox (when applicable), ARC review, document deletion. TMF Classifiers or Start Up team members as part of the SSU Vault Model typically fulfil this role (TMF Classifier).•Maintains the TMF in a state of audit readiness for quality and compliance by:•Visual quality checks of e-documents prior to release to confirm image clarity and readability.•Performing Audit Ready Checks on individual documents uploaded in the eTMF system for every study, ensuring context is accurate;•Comply with metrics established for performance.•Process and track final essential artifacts required throughout all phases of the study in accordance with company SOPs, sponsor SOPs, GCP and ICH guidelines.•Manages the identification of operational issues and resolutions related to the TMF.•Prepares the TMF for QA or Sponsor audits, the resolution with identifying and implementing corrective actions to findings in audit reports.•Participates in Internal Audits & Client Audit as per study requirements. •Collaborates with all members of BP&S.•Ensures overall client satisfaction for all studies.•Participates in business improvement initiatives to drive quality, productivity, and continuous improvement of business processes.•Maintains an understanding of applicable regulatory requirements.•Attend internal or external study team meetings as required.•Perform Training & Mentoring as required.•And all other duties as needed or assigned. Qualifications (Minimum Required):•Bachelor’s Degree with a' Life Sciences/Business focus. Experience (Minimum Required):•Minimum 3 to 6 years’ experience working in a clinical research environment.•Clear understanding of GCP and ICH guidelines.•Knowledge of Regulatory/Clinical document requirements.•Knowledge of Microsoft Office products, web-based applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs.•Excellent interpersonal skills. Preferred Qualifications Include:•Masters’s Degree with a Life Sciences/Business focus.•Equivalent experience within clinical research environment of a minimum of 3 to 6 years, may be substituted for education requirements.•Experience working in clinical electronic systems. Physical Demands / Work Environment:•Minimal (less than 10%) as required for Sponsor Kick-Off Meetings, Face to Face Client Meetings, when requested. Learn more about our EEO & Accommodations request here. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.

Responsibilities

The Senior TMF Associate manages document classification and deletion for electronic Trial Master Files (eTMF) in clinical studies. They ensure audit readiness and compliance with regulatory requirements while collaborating with study personnel.