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Senior Clinical Document Management Specialist
3 weeks ago
We are seeking a Senior Clinical Document Management Specialist to join our team at Beacon Hill Life Sciences in Boston. The ideal candidate will have a minimum of 5 years of experience in clinical document management, with a strong understanding of electronic Trial Master Files (eTMFs) and Good Clinical Practice (GCP).
Job Responsibilities- Manage the quality and control of clinical documents and eTMFs across various projects and teams.
- Develop and maintain standard operating procedures (SOPs) and work instructions for clinical document management.
- Provide training and support to staff on eTMF systems and best practices.
- Collaborate with Clinical Operations Management to drive new procedures and processes within the department.
We offer a competitive salary range of $110,000 - $140,000 per year, depending on experience. In addition to a comprehensive benefits package, we also provide opportunities for professional growth and development.
Requirements- Bachelor's degree or equivalent combination of education/experience in science or health-related field.
- Minimum 5 years of experience in clinical document management, including eTMF systems and GCP.
- Thorough knowledge of DIA Reference Model and International Council for Harmonization (ICH) GCP principles.
- Experience with electronic TMF applications and software development.
