Contractor - eTMF manager

As part of the Clinical Operations team, the temporary eTMF Manager oversees and manages the development and implementation of eTMF procedures, processes, systems, and training over the study lifecycle in compliance with SOPs and regulatory requirements. The eTMF Manager must have an in-depth knowledge of Inspection Readiness/Preparedness practices and procedures. In addition, the eTMF Manager must actively collaborate with clinical stakeholders and external stakeholders (CROs).Qualifications:   · Bachelor’s degree or equivalent is required. · Ideal candidate will have at least 5 years of relevant experience in either sponsor or CRO (at least 3 years eTMF management experience). · Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations. · Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects. · Experience managing and maintaining eTMF system · Must have extensive experience with Veeva Vault system (eTMF and CTMS) · Extensive knowledge of clinical documents that are maintained in the eTMF · Prior inspection readiness experience is highly desired.Responsibilities: · Oversee and manage the set-up, maintenance, and archival of the Trial Master File (TMF), including the tracking, reporting and analysis of metrics related to clinical trial documentation and administration of the electronic TMF (eTMF). · Maintain inspection/audit readiness while driving completion of the eTMF. · Serve as a business administrator of the eTMF. · Support TMF operations during eTMF implementation, audits, and/or regulatory inspections · Primary point of accountability for the TMF processes and systems; ownership of the eTMF system, including managing and maintaining the system. · Provide adequate training to study teams, including external partners and CRO staff, to ensure that TMF documents are processed in a timely manner and per SOP. · Represent TMF operations at study team meetings, participate in collaborative efforts, and play an important cross-functional role in TMF document retrieval and management. · Coordinate the long-term storage archival of original documents and maintain document integrity, per mandatory retention policies. · Ability to maintain a high level of accuracy and attention to detail in fast-paced environment with shifting priorities. · Demonstrate understanding of the TMF Reference Model filing structure, and clinical electronic document management systems (EDMS) · Self-motivated and able to thrive in a fast-paced, start-up environment.