Chris Hay Email & Phone Number

New Westminster, Bc, Ca

Vancouver, British Columbia, Canada

Vancouver, British Columbia, Canada

* Responsible for project team, site/network, NGS/biomarker & patient surfacing vendors and central IRB oversight for PEN - IQVIA’s on-demand (21 day “just in time”) patient identification and site start-up program for oncology clinical trials. * Responsible delivery of and adherence to Key Performance Indices (KPIs). * Manage and direct efforts between cross-functional project teams to drive milestone delivery.* Lead budget allocation and vendor management/selection activities into project delivery.* Develop work plans in conjunction with all stakeholders. Monitor variance and report project(s) status(es) on an ongoing basis.* Responsible for tracking work execution in relation to delivery and monitoring of vendor costs, reviewing, querying and paying approved invoices and forecasting spend.Oversee preparation, review and present project updates for internal and external audiences, including sponsors and sites.

* Overall responsibility for project delivery managing the “critical path”, key project milestones and scope.* Manage, coordinate and oversee efforts of cross-functional project teams to support milestone achievement and manage study issues and obstacles ensuring consistent use of study tools, systems and training materials in compliance with standard processes, policies, procedures, guidelines and quality standards (e.g. ICH/GCP, Global and Country specific regulations). * Project teams comprised of subject matter experts from, but not limited to, Clinical Operations, Regulatory, Data Management, Safety, Medical, Statistics, Drug Supply as well as 3rd party vendors (IRT, ePRO, central labs, central IRBs/ECs etc).* Prepare and present project information at internal and external meetings, including program governance and stage gate reviews.* Collect and report information on team performance against contract, customer expectations, and project baselines.* Serve as primary project contact with sponsor to ensure communication is maintained and reporting schedules are adhered to.* Lead problem solving and resolution efforts to include management of risk, contingencies and issues.* Develop study management plans, together with team assignments and accountabilities and oversight.* Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.* Manage project budgets (revenue recognition, team utilization, Estimate At Completion [EAC], billable units,). * Participate in proposal development in the RFP/bid-defense process.

Home Based - Vancouver, Bc

Home Based- Vancouver, Bc

* Lead Clinical Research Associate (CRA) who assists the regional and global project managers in clinical operations and management overseeing a team of CRAs across the globe.* Apply clinical research expertise in monitoring and site support across multiple countries, through directly working with CRAs, site and study staff, ensuring process and practice methodology is applied consistently and in accordance with the protocol, SOPs, policies, good clinical practices and applicable regulatory requirements. * Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Visits included site selection, pre-study activities, site initiation, routine interim monitoring, and site close-out visits across Western Canada and USA.* Ensure protocol compliance along with Health Canada & FDA regulations and GCP guidelines.* Function as the primary liaison between site staff and sponsor.* Provide site specific training on protocols, study conduct, and good clinical practices.* Provide ongoing support to site staff to encourage continuous enrollment in order to meet study timelines.

Vancouver, Canada Area

Home Based

Victoria, Bc

B.Sc, Molecular Biology And Biochemistry

Activities and Societies: -Certified Clinical Research Professional (CCRP) -Society of Clinical Research Associates (SoCRA)– 2008.

Bachelor'S Degree With Honors, Molecular Biology And Biochemistry, Molecular Biology And Biochemiestry