Karl D Kendall Email and Phone Number

Directed and provided oversight of client-sponsored clinical development projects according to company Standard Operating Procedures, GCP and ICH Guidelines with total responsibility for oversight and delivery of contracted programs >$100M per client• Serve as primary project contact with internal and external customers to ensure appropriate communication channels are maintained and reporting schedules adhered to. • Work with Business Development to finalize the project budget and Scope of Work and manage project budget(s) to meet financial and company goals, proactively ensuring adherence to change control processes. • Supervise content, format and maintenance of project management information and data tracking systems. • May direct and lead project activities for team members related to their project-oriented tasks to ensure that project/program milestones are met. • Evaluate impact of risk, develop and implement quality and risk management plans for minimizing negative impact on project objectives and deliverables. • Act as the key relationship manager for assigned clients; recommend courses of action regarding customer management issues; implement corrective plans following approval by senior management. • Accountable for the financial oversight and goals for projects of assigned customers to meet company realization targets. • Participate in RFP and budget development, evaluate feasibility of potential programs and impact on company operations and goals. • Participate in sales/proposal presentations in face-to-face meetings with potential customers. • Provide technical expertise and insights into Project Management experience to Project Manager(s)/Direct-Reports and training efforts. • Serve as a Project Management liaison with other groups or departments within company. • May take Project Management Lead role for specified customer(s), including acting as team member on Operations and/or Steering Committees with strategic partners.

Worked in collaboration with other Global Product Directors and clinical development leaders, both U.S. and Central Europe, to develop and test new analgesic compounds & new anti-depressive/anti-psychotic compounds and therapies. Effectively managed cross-cultural team activities in accordance with divisional/departmental goals and objectives by:•Implementing and encouraging “lean thinking”; identifying inputs to the flow of materials, documents and/or information from the early development stages to regulatory filing, and systematically removing redundant or non-value added activities from the flow.•Key point-of-contact, along with Clinical Development Leader, for managing and coordinating tasks/activities/deliverable items from primary CRO; Quintiles Transnational on Duragesic project. Conduct bi-weekly status meetings with Quintiles’ Project Manager and project team to ensure effective cross-company communication and timely resolution of budget or resource issues.

Responsible for directing from start to finish, featured clinical trials services and in development and deployment of MiniDoc hardware products; primarily the Remote Study Management (RSM) system and Electronic Diary. Responsible for working with clients in the US, Europe, South America and the Middle East to understand their clinical / technical / pharmaceutical needs according to project-specific protocols for Phase II – IV clinical trials, define and specify products/features to meet those needs, and steer the project with the development team to deploy the right product on time and within budget.