Employment Classification : Regular/Permanent
Job details :
Position Summary:
The Sr. Manager, Records Management will be responsible for oversight of all study level Trial Master Files including set-up, periodic and final QC and final transfer and archival. The position will develop oversight and TMF archival SOPs and manage the TMF archival platform.
Job Duties and Responsibilities: 
Develop and implement a comprehensive records management strategy including oversight and archival SOPs and set-up and management of a TMF archival platform.
Select and onboard/implement an archival TMF platform.
Oversee the TMF archival process, ensuring that all documents are properly filed, indexed, and accessible.
Ensure inspection readiness state for outsourced TMFs by conducting periodic quality control reviews and following up to ensure timely and appropriate resolution of findings.
Prepare for and support health authority inspections (trial master file QCs, pulling documents during inspections.
Stay current with regulatory requirements and industry best practices related to records management and TMF.

Position Summary:
The Sr. Manager, Records Management will be responsible for oversight of all study level Trial Master Files including set-up, periodic and final QC and final transfer and archival. The position will develop oversight and TMF archival SOPs and manage the TMF archival platform.
Job Duties and Responsibilities: 
Develop and implement a comprehensive records management strategy including oversight and archival SOPs and set-up and management of a TMF archival platform.
Select and onboard/implement an archival TMF platform.
Oversee the TMF archival process, ensuring that all documents are properly filed, indexed, and accessible.
Ensure inspection readiness state for outsourced TMFs by conducting periodic quality control reviews and following up to ensure timely and appropriate resolution of findings.
Prepare for and support health authority inspections (trial master file QCs, pulling documents during inspections.
Stay current with regulatory requirements and industry best practices related to records management and TMF.
Adress : USA