Trial Master File Jobs in Massachusetts
of the trialmasterfile
Collaborate with internal colleagues, external regulatory and quality consultants, and external organizations, to support the timely execution of regulatory submissions, authoring of responses to questions, audits and inspections...
clinical study documentation in an electronic format. Ensures study compliance with OPUS SOPs and regulatory guidelines by performing periodic quality control audits of any trialmasterfile (TMF) maintained by the Service Provider (SP) before study...
SOP development and review, management of clinical systems, oversight of clinical metrics tracking and reporting), inspection readiness efforts and audit-ready TrialMasterFiles reviews (internal and at CRO).
Travel required: up to 40%
Requirements...
- Supports the development and implementation of department initiatives including input on certain SOPs, processes, and workstreams...
and communications to KOLs, CROs and other external vendors
- Organize and prepare study files related to study tracking and reporting and submit them to the TrialMasterFile within established guidelines, maintain up:to:date documentation for all study sites...
- Develop, review, and implement SOPs relating to GCP, as needed; support development and implementation of Quality Management System
- Stay abreast of changes in applicable FDA...
- Ensure Meticulous Documentation: Oversee clinical and regulatory files, including the essential TrialMasterFile (TMF).
Requirements
About you...
- Conduct a Quality Assurance review of clinical study reports and audit trialmasterfiles for applicable regulatory compliance.
- Develop, review, and implement SOPs relating to GCP, as needed; support development and implementation...