Senior Clinical Document Specialist
21 hours ago
Job Title: Document Management Specialist
">- Process clinical study documents in accordance with client and project requirements, adhering to SOPs/WPs and relevant regulations.
- Liaise with project teams and other staff to ensure effective fulfillment of responsibilities.
- Complete assigned projects within specified timelines, ensuring adherence to regulatory standards.
- Maintain study files in compliance with client/project requirements and SOPs/WPs.
- Handle document receipt and processing tasks, including reviewing, scanning, indexing, and archiving.
- Provide necessary information for status reports as requested by clients and management.
- Inform the Manager of training issues, project activities, quality concerns, and timelines.
- Participate in audits and document archiving activities as needed.
- Assist in training sessions related to your responsibilities.
- Address project issues with clients under the direction of the Manager.
- Undertake special projects or additional duties as requested.
Required Skills and Qualifications:
">- 1-15 years of experience in TMF (Trial Master File) with strong knowledge of clinical study documents.
- Able to effectively liaise with project teams, staff, clients, and management.
- Excellent oral and written communication skills.
- Bachelor's Degree in Life Sciences preferred.
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