ఉద్యోగ వివరణ

About the Company

This global biopharmaceutical organization is dedicated to leading the advancement and commercialization of immune-based therapies for patients worldwide. With clinical development and operations extending globally, the company maintains a balanced portfolio focusing on first- and best-in-class autoimmune therapeutics addressing significant unmet medical needs. Through a strategic business development approach, they are expanding their pipeline, with a leadership team and partners committed to operational excellence and delivering potentially groundbreaking treatments for autoimmune and rare diseases.

Position Overview

Reporting to the Clinical Project Manager, the Clinical Trial Document Specialist will ensure the maintenance of high-quality Trial Master Files (TMFs) during ongoing and completed clinical trials. This role requires adherence to regulatory standards, ICH-GCP guidelines, and SOPs, focusing on the successful fulfillment of all TMF deliverables.

Core Responsibilities

Collaborate with Project Leads, Clinical Study teams, and Contract Research Organizations (CROs) to uphold TMF quality and compliance throughout study lifecycle.
Contribute to study setup by developing TMF Plans, Oversight Plans, Expected Document Lists, and handling archival or transfer as necessary.
Monitor operational metrics to oversee the TMF effectively.
Provide routine TMF reports to study teams, track completeness and trends, and coordinate corrective actions when needed.
Work with Project Leads to identify TMF-related risks and ensure regulatory compliance.
Supervise CRO and internal teams in managing clinical documentation, including preparation, distribution, filing, and archiving per procedures.
Conduct quality control reviews and maintain oversight of TMFs for assigned projects.
Manage TMF user access as needed.
Ensure TMF inspection readiness and document review outcomes.
Drive process improvements as the subject matter expert in TMF management.
Participate in departmental and trial-specific meetings as required.
Support audits and inspections related to TMFs.
Stay current on SOPs, DIA reference models, GCP, ICH guidelines, and relevant regulatory standards.

Qualifications

Bachelor's degree in biological sciences or a related discipline, or equivalent experience.
Experience in pharmaceutical or biotechnology industries, especially in records management within GCP-regulated environments.
Strong written and verbal communication capabilities.
Proficient in MS Word, Excel, and Project, with excellent analytical and problem-solving skills.
Highly detail-oriented with strong organization and time management abilities.
Experience using Veeva Vault electronic Trial Master File (eTMF) system.

Additional Information

Full-time employees are eligible for benefits including health insurance, life and disability coverage, as well as 401(k) plans.

The company embraces diversity and inclusion, ensuring equal employment opportunities regardless of personal attributes protected by law, including but not limited to sex, race, age, religion, gender identity, sexual orientation, disability, and veteran status.

Reasonable accommodations are provided for applicants with disabilities throughout the hiring process upon request.

Remote Clinical Trial Document Specialist - U.S.