Donna Carter, Mcpm Email & Phone Number

Whitby, On, Ca

Toronto, Ontario, Canada

● Executed site initiation administrative tasks with meticulous organization, adhering to timelines, regulations, and guidelines. Compiled comprehensive documentation to qualify clinical sites, study teams, and committees before their initial site visit.● Conducted quality assessments on essential documents, improving document integrity and compliance through communication and staff retraining. Maintained audit readiness at all times, successfully reducing document error rates to below 8%. ● Contributed to the development of guidance documents that provided oversight in the management of complex clinical trials. This resulted in enhanced working instructions for management plans, training matrices, and decision logs that improved comprehension and clarity for optimal performance among study team members.● Participated in project meetings, facilitating updates from team members, scribing minutes for accurate documentation. Actively managed project risks, actions, decisions, and issues within a collaborative team-oriented environment that contributed to 100% regulatory compliance in study start up.● Successful vendor oversight in the transfer of clinical data and study documentation to meet end of study deliverables. Prepared and executed long-term sample storage contract with vendor. ● Reviewed and reported on clinical trial budgets exceeding $3M by managing amendments, executing change orders within specified parameters reducing costs by 6%.

Provided project and operational support for global Clinical Operations in Canada and United States.● Accomplished seamless communication and content management across teams to achieve regulatory readiness in clinical trial applications by coordinating and leading cross-functional team meetings. This involved creating agendas, preparing and distributing meeting materials in a digital repository.● Served as subject matter expert (SME) for project management tool used for integrated planning of clinical trials. Developed country & site-level templates, addressing critical path requirements while optimizing schedule performance. ● Accomplished the optimization of clinical trial operations by establishing a robust operational process. Implemented a centralized system for distributing safety information from across 50 trials at over 500 sites, reducing administrative burden on individual Canadian clinical trial sites and streamlining reporting to central ethic boards.● Led team of eight (8) colleagues over six months conducting 30 in-person strategic meetings that streamlined document management processes while transitioning to a new digital platform. This resulted in strengthening expertise levels within the team and enhancing access, retrieval, and organization of 500,000 electronic records.

Provided administrative and operational support for Canadian Clinical Operations and its directors, project leaders, and regional managers.● Demonstrated initiative and problem-solving skills by coordinating, executing, and integrating a global call center into a local on-site platform. Achieved the result of delivering and maintaining consistency for the in-bound patient caller experience.● Proposed and implemented a new reimbursement model for clinical trial sites, which improved payment efficiency, met financial policy compliance, and enhanced the flow of reimbursements to clinical trial sites within payment terms.● Served as subject matter expert in time-entry project for the R&D division, creating tools and training associates that ensured accurate data entry and annual reporting for R&D finance. ● Designed reports and aggregated information across multiple systems to provide information-on-demand required for evaluation and analysis of site performance in a dynamic, fast paced work environment driving performance improvements. ● Organized meetings, workshops and conferences for global clinical organization taking care of travel, accommodation, venue, catering, and meeting materials.

Administrative support to the Associate Director, Regional Research Managers, and therapeutic area clinical trial project managers providing support in schedule, communication and information management, and all aspects of office management.● Gathered requirements to design MS SharePoint team collaboration site and managed content in accordance with global record retention schedule as SharePoint SME in data steward and site collection administrative role.● Compiled clinical data information for distribution to executives across the organization, maintaining compliance with principles of medical research policies (privacy) and procedures.● Managed multiple calendars and screened for conflict resolution optimizing resources, time and space requirements.● Prepare travel schedules, book travel arrangements, and make reservations for leadership team.● Managed office space configurations. Demonstrated autonomy to facilitate floor plan changes during phases in major office renovations, relocations. ● Supervised and coached summer students, ensuring successful experience for individuals and company. ● Engaged and influenced fellow colleagues to participate at company’s community volunteer event.● Subject Matter Expert (SME) in various areas including clinical trial performance metrics and SOPs.

Assistant to Vice President of Rogers iMedia, General Manager of Springboard.ca and provided administrative support to team members. Translated sales concepts into project plans, time line and responsibility charts. Coordinated responsibilities of team members for micro site project, set timeframes and delivered on deadline.

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