Support the successful migration/indexing of clinical study trial Master files into the new eTMF system (Pharma TMF) through the provision of support to the CPSSO Study Accountable Person (SAP) and their Study Team members e.g. Clinical Development Scientists and Clinical Data Scientists (as appropriate)) to agreed quality and data integrity standards.
Provide support to the CPSSO clinical development or data scientist team members as needed (e.g. instream review of data, drafting and preparation of documents etc.) to support their TMF migration/indexing and study deliverable targets.
Serve as point of contact for the migration/indexing study teams for TMF matters, and liaise with the other TMF Subject Matter Experts (SMEs) and process owners to help their understanding of requirements and associated solutions to ensure the migrated and indexed TMFs are inspection ready
Support the analysis and identification of business problems/opportunities that may arise during the migration/indexing and, support the implementation of high quality solutions
Address requests in a timely and efficient manner
May assist in the development and delivery of training materials providing subject matter expertise and know how
Knowledge and experience of using clinical trial master file (TMF) systems (paper or electronic) and associated business processes
Knowledge of Trial Master File industry accepted standards, such as the DIA’s TMF Reference Model
Knowledge of electronic document management applications (e.g., Documentum, SharePoint, Livelink)
Excellent working knowledge of International Conference on Harmonization/ Good Clinical Practice (ICH/GCP) regulations for sponsor study records
Excellent interpersonal skills, including the ability to establish and maintain effective working relationships with customers, peers and stakeholders
Proven record of being customer driven and providing effective consultation and training
Self starter, able to work in independence as well in matrix team environment
Analytical / logical, with superior attention to detail and an inclination to spot patterns and outliers
Bachelors Degree in a scientific discipline
Minimum of 3 years experience from a CRO or Pharma working in clinical research, clinical operations or data scientist roles (eg Study Manager, Clinical Research Scientist, Clinical Data Scientist, Data Manager and/ or in records management).