Lisa Mulcahy

Lisa Mulcahy is aversified clinical research professional with more than 25 years of experience in the pharmaceutical research industry. Her current focus is clinical research document management, tying all previous work experiences together to develop and implement high-quality document management processes focusing on the Trial Master File, and QC of TMF documents. She has extensive experience in conducting clinical trials, evaluating quality within clinical trial processes, and the management of documents created during the conduct of clinical trials, all according to ICH-GCP Guidelines.

• TMF management and process assessment and improvement; TMF content mapping to TMF RM; eTMF implementation, and TMF procedural documentation development and associated training.
• Clinical research trial management/coordination and quality control activities associated with clinical research documents
• Business domain expert, and/or content architecture and structure (taxonomy) Clinical document and records management; including participation in the establishment of clinical processes for the trial master file, development of clinical record retention schedules, & development/revision of clinical research record management procedures.
• Preparation/review of procedural documents (SOPs, manuals, guidelines, etc.)
• Current Steering Committee Member of the TMF Reference Model Team
• Current Chair of the DIA Document & Records Management Community (previously called SIAC)