Nancy May

• Acted as a primary lead in the set-up, organization and maintenance of clinical study documentation (e.g. Study Files, CRFs, safety reports, etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archival with minimal to no oversight by PM/CTM
• Assisted in the processing of Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study
• Supported with various tracking reports including but not limited to team member tracking and training, by updating the Clinical Trial Management systems, providing access to systems and addressing any discrepancies with minimal supervision.
• Assisted in verification and co-ordination of study related payments or document translation when required.
• Mentored and trained new/less experienced Clinical Trial Assistants (CTAs), including identification of training needs
• Anticipated the needs of the study team and keep CTM/PM informed of any issues requiring attention.
• Primary lead in the coordination of meetings/attend the meetings, preparation activities and the generation of meeting agenda and minutes with minimal to no supervision and regularly attend and contribute to project / client specific meetings.

Protocol Therapeutic Experience

• Cardiology/Vascular Diseases- Phase III
• Gastroenterology- Phase II
• Inflammation/Immunology- Phase III
• Vaccines- Phases I, II, III, IV

• Assisted in the coordination and administration of clinical trials, ensuring compliance with protocols and regulatory requirements.
• Maintained and organized clinical trial documentation, including study files, essential documents, and regulatory submissions.
• Supported the preparation of study-related materials, such as informed consent forms and case report forms.
• Worked with cross-functional teams to facilitate communication and ensure smooth trial execution.
• Contributed to the tracking and reporting of clinical trial metrics and milestones.