Summary
• Support QC/completeness checks on all global TCO study TMFs in accordance with Novartis SOPs, working practices and ICH/GCP Guidelines. Follow-up with the CTT to resolve quality issues identified and escalate potential SOP/WP deviations.. • Maintain up to date knowledge of the TMF Reference Model. Support documentation of appropriate oversight and tracking of TMF QC activities.
About the Role
Your responsibilities include, but are not limited to:
• Support QC/completeness checks on all global TCO study TMFs in accordance with Novartis SOPs, working practices and ICH/GCP Guidelines. Follow-up with the CTT to resolve quality issues identified and escalate potential SOP/WP deviations..
• Maintain up to date knowledge of the TMF Reference Model. Support documentation of appropriate oversight and tracking of TMF QC activities.
• Execute trial TMF QC activities in accordance with TCO portfolio and Clinical Operations Transition Decision Point (TDP) and Clinical Study Report (CSR) dates. Support CTTs with audit/inspection prep activities.
• Track TMF key quality indicators (KQIs) and overall compliance to the TMF processes and regulations. Provide training to the CTTs on TMF processes and QC measures.
• Participate in CTT and TMF Ops Service meetings supporting resolution and close out of TMF review findings. Serve as SuperUser (SU) on document management systems (e.g. CREDI, Subway, Novartis Clinical Vault (NCV)).
• Serve as a SuperUser for ARONDA, the archival document management system, supporting teams with retrievals of documents on request. Participate and/or lead meetings related to TMF processes and trainings (e.g., Clinical Compliance Forum meetings)
• Participate in the on-boarding and training of new ClinOps staff as related to document management process in TCO.
• May serve as TCO representative on TMF process improvement initiatives, committees, work streams and governances. May perform Clinical Project Associate (CPA) tasks as assigned
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
• A minimum of 1 year experience in the Pharmaceutical Industry with knowledge and experience in quality management reviews of the Trial Master File, preferred.
• Ability to work effectively on either self-managed projects or as a team member.
• Ability to adjust to multiple demands, shifting priorities, and unexpected events in a fast-paces environment while maintaining a positive work attitude.
• Self-motivated with a high degree of ownership and accountability for results.
• Developed or have participated in the development of guidance documents, work practices and tracking tools.
• Provided training and mentorship to a colleague on a 1:1 basis or in a meeting setting.
• Bachelor’s degree or equivalent education/degree qualification in life science/healthcare required.