
Senior Clinical Document Management Specialist
3 days ago
Job Description
">- We are seeking an experienced Clinical Document Management Specialist to join our team. In this role, you will be responsible for managing clinical documents under the eTMF system, ensuring they are classified and reviewed correctly.
- You will also ensure that the eTMF is maintained in a state of audit readiness by performing visual quality checks on e-documents before release, and conducting audit-ready checks on each document uploaded.
- The ideal candidate will have a strong understanding of GCP, ICH guidelines, and regulatory/clinical document requirements, as well as proficiency in Microsoft Office and web-based applications.
Requirements
">- Education: Bachelor's Degree in Life Sciences, Business, or a related field.
- Experience: A minimum of 3-6 years of experience in a clinical research environment, with a solid understanding of clinical document management and eTMF processes.
- Technical Skills: Proficiency in Microsoft Office, web-based applications, Adobe Acrobat Standard, and the ability to apply software tools related to document management, scanning, and eTMF systems.
Benefits
">- This is a full-time position with minimal travel required (less than 10%) for Sponsor Kick-Off Meetings, Client Meetings, or as requested.
Others
">- You will work closely with internal teams and external partners to ensure client satisfaction and support the timely and efficient completion of clinical trials.
- The company offers a competitive salary and benefits package, including health insurance, retirement plan, and paid time off.
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