Job Description :
TMF Specialist
6 Months
San Rafael, CA

Responsible for working with study teams to manage trial master file (TMF) records, both electronically and paper based. Management responsibilities includes creating and maintaining TMF governance documentation, performing quality reviews of TMF content and ensuring that study specific TMF’s are inspection ready at all times. The role accurately identifies and tracks content inventory and coding of the TMF documents as assigned. Generates and manages reports of TMF inventory, errors, missing documents, misfiled documents for all assigned studies.
Working consistently with study teams to manage trial master file (TMF) records, both electronically and paper
Creating and maintaining TMF Management Plans
Creating and maintaining TMF Content Plans
Scheduling and facilitating TMF Comprehensive Reviews
Collection of study specific TMF content, (both external and internal to client)
QC of TMF content and coding
Ensure proper close-out of TMF related issues
Point person for study team’s TMF questions
Providing input on the improvement of TMF processes
Facilitating TMF Meetings
Archiving of the TMF content
Generating inventory reports and all associated mitigation activities of the TMF.
Reviewing TMF records and reconciling them in client’s records management databases, such as the Records Management Database, Livelink and CTMS as assigned.
performing inventory activities for off-site storage of Development Sciences records in accordance with the DevSci Records Management (DSRM) SOP.
Responsible for understanding, supporting, revising and using Records Management database programs (e.g., Access databases, Livelink or other
May provide input on the revision of TMF related Work Instructions and SOP’s
Coding TMF documents per DIA and legacy client coding formats.
May generate and present Records Management procedures to various internal stakeholders (e.g., other document management staff, customers, etc.
May represent DSQ at various team meetings.
May participate or lead in the training of DevSci personnel, either in groups or individually.

MS Office
eTMF experience preferred

BA/BS or eight plus years industry experience required.
Combination of educational and work experience providing competencies to perform the required responsibilities specific to position.

Clinical Research Associate (CRA) or equivalent experience desired
Relevant Records Management experience working with TMFs
Has an advanced understanding of the clinical study phases involved in drug development and the corresponding records requirements
Worked successfully on large teams in the support of clinical trials while demonstrating strong interpersonal skills