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Senior Document Management Specialist
2 weeks ago
As a Senior Document Management Specialist, you will play a pivotal role in ensuring compliance with our organizational values:
- Embracing and contributing to our culture of excellence and process improvement is paramount.
Beyond Compliance:
- You will develop and implement Trial Master File (TMF) specifications that align with program strategies and milestones.
- Support responses to regulatory authorities regarding documentation management for audits, questions, and issues.
- Review data quality and audit outputs to identify trends and ensure consistency across programs.
Process Optimization:
- Standardize processes and systems across all clinical trials.
- Identify and implement continuous improvement opportunities to enhance operational efficiency.
Audit and Inspection Support:
- Serve as the primary point of contact for internal and external audits related to study TMF queries.
- Support the preparation of audit and inspection responses.
Talent Development and Communication:
- Provide guidance and support to the Document Management Team to drive performance and resolve conflicts.
- Educate and mentor team members on good document management practices for clinical trials.
Cross-Functional Collaboration:
- Foster communication among stakeholders regarding TMF matters.
- Collaborate with Document Owners, Sponsors, Vendors, and Study Teams to ensure TMF readiness and compliance.
Why Join Our Organization?
- We offer competitive salary packages and annual bonuses based on performance.
- Comprehensive health-related benefits and retirement plans.
- A supportive environment that encourages personal fulfillment and drives lasting change
