Our clinical stage pharmaceutical client here in Boston, MA is growing and looking to add an Associate Director, Clinical Documentation Operations (REMOTE) to their team! This role will serve as a SME and primary point of contact for activities associated with ensuring the Trial Master Files (TMFs) meet compliance, quality, archival, and inspection readiness standards. In addition, support functional areas to oversee end to end TMF management including activities outsourced to CROs and Third-Party Vendors. Other responsibilities include but not limited to:
Define TMF management related processes and develop related tools.
Support functional areas with execution of processes related to TMF management in accordance with the company guidelines and standard operating procedures.
Support to produce inspection ready TMFs for ongoing and legacy studies.
Define the TMF oversight process and support functional areas with its execution.
Manage activities related to the TMF transfers from CROs and Third-Party Vendors and their long-term archiving in Veeva eTMF (Archive).
Coordinate the work of contracted TMF Specialist(s) and CSV consultant(s).
Provide TMF management related guidance and training to the company functions executing TMF management processes.
Collaborate with CRO functions on development of study specific TMF process and on TMF quality issue follow-up until resolution.
Performs activities related to the system administration of Veeva eTMF (Archive) incl. execution of change control process, if applicable, and Risk Impact Assessments related to the system upgrades.
Requirements:
BS/BA degree or equivalent (background in life sciences preferred) AND at least 5 years+ of TMF experience.
Familiar with ICH GCP and FDA regulations.
Detailed understanding of TMF and eTMF systems, principles, practices, and workflows.
Experience maintaining and reviewing TMFs, including TMF artifact and indexing.
Experience with the CDISC TMF Reference Model.
Experience with oversight of TMF management activities performed by CROs and Third-Party Vendors.
Ability to manage multiple projects and effectively prioritize activities.
Experience with the TMF inspection preparations.
Experience with Veeva Vault eTMF. (preferred)
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