Donna Carter, Mcpm Email & Phone Number

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• 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.
• 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.
• 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.
• 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.
• 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.

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.

Master Certification In Project Management (Mcpm), Project Management, Honours

Professional Coaching

Foundations, , Adler School of Professional Studies

Introduction And Intermediate Html

Marketing, Ryerson, April 2001

Teambuilding And Leadership Certificate

Computerized Business Systems

High School Diploma, Honours