Our client is a growing clinical-stage, publicly traded, international pharmaceutical company.
They have engaged Afton Consulting Group to help them identify and hire a Trial Master File (TMF) Manager.Description:The Trial Master File (TMF) Manager is responsible for the company’s TMF processes including the implementation and overall management of both paper-based and electronic processes and systems (e.G., eTMF system), day-to-day operations, development and oversight of TMF procedural documents such as TMF SOPs and standards, and development and generation of reports and key performance indicators to measure completeness, accuracy, and timeliness of study documents with a strong focus on ensuring that document management operations are performed in accordance to company standard operating procedures (SOPs), ICH-GCP and regulatory guidelinesQualificationsPrefer candidates with BA/BS degree and 2 years of organizing and coordinating Trial Master Files for clinical trialsExperience working with electronic TMF systems (ideally Veeva Vault)Experience with the DIA Reference model and a good understanding of records management best practicesExperience working on global/international studies is advantageousResponsibilitiesThis is a global role and will require working with global Project Team members, Clinical Research Organizations, 3rd Party Vendors, and Quality AssuranceProvide primary support to ensure inspection readiness of the Trial Master Files (TMF)Deliver technical expertise in the Trial Master File management and will provide oversight of clinical trials throughout the lifecycle of the trialLocationThis position is 100% remote