Darshika Mistry

Clinical Project Consultant Clinical Research Specialist @Profound Medical Inc.

Leadership in Clinical Projects: Managed complex, high-profile projects, stepping into roles such as Global Study Manager, Sr Trial Manager, Clinical Data Manager, Senior Monitor, and Start-up and Close-out Specialist.• Cross-functional Collaboration: Worked with business units across North America and Europe, directly partnering with Sponsors and CROs to implement clinical studies.• Stakeholder Communication: Collaborated with business leaders and/or Program owners to identify and prioritize programs/projects, translating business strategy into project goals and measurable objectives.• Project Planning and Execution: Developed, managed, and implemented charters and project plans, outlining work plans, timelines, roles, and resources for multiple workstreams. Directed project execution by assigning tasks, managing resources, and tracking project schedules.• Risk and Issue Management: Tracked and managed risks, actions, issues, decisions, and metrics for overall projects, escalating and driving risks/issues to resolution. Developed and executed contingency plans.• Compliance and Quality Assurance: Ensured compliance with sponsor/investigator obligations, regulatory requirements, and quality standards. Conducted routine follow-ups, audits, and regulatory inspections, ensuring projects received ratings of compliance and good standing.• Subject Safety: Supervised subject safety and adverse event reporting to sponsors and IRB/IEC. Oversaw data snapshots, interim analyses, and database locks.• Mentorship: Acted as a mentor, providing project management guidance and coaching to team members and others outside the project.• Communication and Training: Developed and executed project communication and training plans, providing updates to senior management and stakeholders on project progress through reports, meetings, and other channels.