Clinical Document Specialist
3 weeks ago
**Job Summary:**
We are seeking a highly skilled Clinical Document Specialist to join our team at ARDEM Data Services. This role involves reviewing and providing feedback on medical documents to ensure their accuracy, quality, and compliance with regulatory standards.
About the Role:
- Document Review: Conduct thorough reviews of various medical documents, including clinical trial reports, regulatory submissions, patient records, research papers, and medical communications.
- Feedback Provision: Provide detailed and constructive feedback on the content, structure, and clarity of medical documents, identifying errors and suggesting improvements.
- Quality Assurance: Ensure that reviewed documents meet internal quality standards and external regulatory requirements.
- Regulatory Compliance: Verify that documents comply with relevant regulations and guidelines, such as those from the FDA, EMA, ICH, and GCP.
Required Skills and Qualifications:
- Educational Background: A degree in life sciences, medicine, pharmacy, or a related field.
- Experience: Previous experience in medical writing, regulatory affairs, clinical research, or a related area.
- Attention to Detail: Strong attention to detail and ability to identify errors and inconsistencies.
- Communication Skills: Excellent written and verbal communication skills.
- Regulatory Knowledge: Familiarity with relevant regulations and guidelines.
- Analytical Skills: Strong analytical and critical thinking skills.
Salary Estimate: $60,000 - $80,000 per year, depending on experience.
About ARDEM Data Services:
ARDEM Data Services is a leading Business Process Outsourcing and Business Process Automation Service provider. We offer a dynamic work environment and opportunities for growth and development.
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