Sunee Chuasuwan

- Serve as a primary contact for an assigned vaccine development program with funder, key stakeholders (internal and external).

- Supports the development and management of the vaccine development program (i.e., initiating, planning, executing and closing) within agreed timelines, budget, scope and required quality

- Provide collaboration with the cross functional team leaders and workstream leaders, ensuring tasks are prioritized and diligently completed.

- Support project discussions with the workstream leaders, the functional Leads and key stakeholders including provide guidance to the team members.

- Collaborate with project finance administrative team in preparing the finance and technical progress report for program director to review and submit to funder.

- Coordinates and facilitates cross-functional information sharing, decision-making and issue resolution within the project team to ensure a seamless project conduct and delivery.

- Clinical Project Leader direct or manage in the execution of complex, multi-regional or global clinical study(ies) per contract, from initiation through to closeout.

- Serve as primary contact to Sponsor;

- Direct or Supervise team performance against contract, customer expectations, and project baselines and any resolution efforts.

- Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles

- Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.

- Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.

- Lead problem solving and resolution efforts to include management of risk, contingencies and issues.

- Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.

- Provide input for the development of proposals for new work and manage project budgets.

- Provide input to line managers of their project team members’ performance relative to project tasks.

- Prepare and present project information at internal and external meetings.

- Participate in proposal development and in the bid-defense process.

-Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.

-Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.

-Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.

-Collect information on team performance against contract, customer expectations, and project baselines.

-Lead problem solving and resolution efforts to include management of risk, contingencies and issues.

-Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.

-Provide input for the development of proposals for new work and manage project budgets.

-Provide input to line managers of their project team members’ performance relative to project tasks.

-Prepare and present project information at internal and external meetings.

-Participate in proposal development and in the bid-defense process with guidance and supervision.

-Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team.

- Manages the clinical team’s resources in supporting monitoring activities (Aug 2006-May 2010)

-Trains and develops team members’ skill of conducting study -Ensures the project within clinical team managed in accordance with the clinical operation’s SOPs and ICH GCP

-Supervises and performs clinical monitoring activities -

Assists in project and business development plan Managed projects in CTL and PM roles as required (Jan 2010-May 2010)

-Manage and co-ordinate efforts of cross functional teams to support milestone achievement

-Manage study issues and obstacles

-Ensure use of study tools and materials are compliance with standard processes, policies and procedures

-Ensure high performance and efficacy of the clinical team member through the scheduling of accompany site visits

-Develop study management plans and set up clinical system for study -Review site visit reports

-Identify quality issues within study to implement appropriate corrective action plan to appropriate parties

-Serve as primary project contact with sponsor

-Lead problem solving and resolution efforts include management of risks/issues.

-Provide input to sale/bid defense for new work and manage project budget

-Develops protocol, SOPs, and study case report forms

-Provides protocol training and GCP training to all research site staffs -Supervises completion of quality control of study monitoring and data collection

-SAE management

-Before trial activities; protocol development, investigator site selection, document preparation and approval, and start-up meeting -During trial activities; monitoring, data management, adverse event reporting, and clinical trial management

-After trial activities; study close out, and study report archiving -Ensure all aspects of clinical trials are maintain to meet GCP, and regulatory standard

-Prioritize clinical trial activities to achieve time frame

-Respond to enquired medical information within time frame