Kelly FSP is looking for an Essential Document Specialist on behalf of a leading pharmaceutical client. The role involves ensuring the integrity and readiness of essential clinical trial documents, supporting Essential Document Specialists and Leads, and optimizing processes. The position offers the opportunity to work remotely in a dynamic team and contribute to clinical trials’ regulatory compliance.
Key Responsibilities:
- Support Essential Document Specialists and Leads in clinical trials.
- Develop strategies, procedures, and tools for document management.
- Maintain processing timelines and ensure compliance with regulatory requirements.
- Ensure the integrity of clinical trial documents and provide TMF (Trial Master File) status reports.
- Create, update, and maintain study-specific TMF Plans.
- Assist in document archival and review processes.
- Liaise with internal clinical teams and external partners.
- Ensure the trial’s inspection readiness and participate in audits.
Requirements:
- Minimum of 1 year of experience in clinical research.
- Strong time management skills and attention to detail.
- Ability to manage multiple projects with different deadlines.
- Proficient in Adobe Acrobat and Microsoft Office Suite (Word, Excel, Outlook).
- Knowledge of eTMF (electronic Trial Master File) preferred.
- Understanding of ICH-GCP (Good Clinical Practice) guidelines and relevant regulations.
- General knowledge of clinical trial management and quality management tools.
- High School Diploma required; Bachelor’s degree preferred.
