Joana Ride Leitao

As a Global Principal Clinical Team Manager:

• Drives and owns the clinical deliverables at a global level ensuring timelines, resources and quality are maintained and adequate;
• Leads team of regional CTMs to drive and achieve consistency on study deliverables across regions;
• Provides project-specific training, leadership and therapeutic knowledge to the clinical team to achieve project goals and maintain motivation;
• Develops functional project plans and tools including appropriate system set-up as needed;
• Leads the development of the monitoring strategy at a project level accounting for potential risks and bringing solutions when issues arise. Utilizes data sources available to proactively identify emerging risks;
• Forecasts and reconciles clinical budget in accordance with scope, proactively identifying and partnering with Project Lead and sponsor to address any out of scope tasks;
• Collaborates with the Project Lead, Project Functional leads and other stakeholders to prepare, organize and present during internal or external meetings.

• Oversaw daily line management responsibilities of assigned team.
• Served as positive leadership and professional role model for respective staff, which may be inclusive of CRAs, Project Assistants (PAs), Remote Site Monitors (RSM) and other clinical focused staff.
• Provided direct coaching and development support to operational teams.
• Ultimately responsible for effective resourcing, alignment, training, and on-going professional and technical development for staff.
• Collaborated with Clinical Management senior management and executive staff on strategic planning and business development as required.
• Primary focus online and performance management of team members.
• Acted as point-of-escalation regarding performance concerns and training needs to ensure adherence to PPD SOPs and WPDs.
• Worked in collaboration with the leadership team for resourcing needs.

• Performed and coordinated all clinical monitoring and site management processes, ensuring that trials were conducted in compliance to the study Protocol, ICH-GCPs, local regulations and applicable SOPs.
• Responsible for all monitoring visit types, from pre-study visits (PSVs) until study close-out visits (COVs).
• Supported feasibility and start-up teams on the earlier stages of a trial, on site identification and selection, as well as supporting on Ethics and Regulatory submissions.
• While on site during site's monitoring visits, was responsible for review of source data/documentation, source data verification, and for review of CRF data and data collected in any applicable study-specific collection tools. Was also accountable for IP accountability tasks and for study supplies review.
• Closely worked with sites during studies' Interim Analysis and Database Locks, to ensure that studies' milestones were achieved.
• Attended to several CRA and Investigators meetings.
• As a Senior Clinical Research Associate, besides the tasks listed above, was responsible for mentoring and supporting junior CRAs.
• As a Lead Clinical Research Associate, assisted Clinical Team Managers and/or Project Managers on large multinational studies to supervise and coordinate the clinical activities of CRAs within the project and assisted in the clinical deliverables of the project being met.

Provided support to Clinical Research Associates and Clinical Team Leaders in all clinical related activities.