Senior Clinical Data Manager
hace 1 semana
About the Role
We are seeking a skilled Sr TMF Analyst to join our team at IQVIA Argentina, working in a full home-based setting with a location in Mexico. This role offers an exciting opportunity to work on Trial Master File (TMF) management and provide operational support to clinical trial teams.
Key Responsibilities
- Manage the sponsor TMF structure and records in the system, ensuring accuracy and completeness.
- Create file plans for document requirements using Veeva Vault, our preferred eTMF platform.
- Maintain expected numbers of documents in the sponsor eTMF by supporting signpost management.
- Perform quality and completeness reviews of the TMF.
- Support inspection readiness activities as needed.
- Collaborate with other teams/roles to create training materials and job aids.
- Resolve issues in collaboration with other teams, identifying gaps and escalating if necessary.
Requirements
- Bachelor's degree, preferably in a scientific discipline, is required.
- Demonstrated proficiency with TMF Management, with a minimum of 4 to 5 years of experience with eTMF systems/platforms.
- Strong knowledge of DIA Reference Model for TMFs, ICH GCP, regulatory requirements, and regulations.
- Familiarity with eTMF platforms, particularly Veeva Vault, is a plus.
- Working knowledge of clinical research documents and study life cycle milestones in Veeva Set up, EDL management, tailoring.
- Demonstrated current knowledge of ICH, GCP, and other regulatory guidance applicable to clinical documentation management.
- Ability to work in a fast-paced environment with changing priorities.
- Excellent communication and teamwork skills.
- Attention to detail and accuracy in work.
- Experience with Microsoft Office suite, with proficiency in Excel being a plus.
Estimated Salary Range: $65,000 - $85,000 per annum, based on qualifications and experience.
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