Eve-Marie Whitsun-Jones, Associate, has been with Waife & Associates since 2004. She has a diverse background in clinical project management, postmarketing research, regulatory systems, and clinical finance, with additional experience in managing EDC implementation from the clinical operations perspective. At W&A, she has worked on one of the largest cardiovascular postmarketing trials, has led EDC and eTMF implementations, worked on safety surveillance optimization, and various audit and training services. Before joining Waife & Associates, Ms. Whitsun-Jones spent twelve years at Pfizer, where she was active in eSubmissions, finance systems, implementation of ASP-based EDC, and clinical operations.

She and other W&A staff have also managed projects that extract, transpose and deliver study-level data into Clinical Data Warehouses for inclusion into statistical programming efforts and submission of new product registrations. She and other W&A staff have direct experience in the use of typical CDW tools such as SAS Drug Discovery and JReview, and is also familiar with ODM and SDTM data models and their downstream use by statisticians, either as SDTM or ADaM data sets.

In a series of management positions at Pfizer, her experience included managing the development and implementation of a system to track regulatory events & activities as they related to submissions to Health Canada, managed the development and implementation of a CTMS to track and Canadian clinical and financial R&D activity for Phase 3b-4 trials, and developed a clinical supplies management system which ensured GMP-compliant tracking and inventory management. Ms. Whitsun-Jones was a representative on the APETI (Advisory Panel on the Electronic Transfer of Information).

She received her undergraduate degree in Biology from McGill University. She is fluent in French and staffs our Montreal office.