Bernadette Vinarao

• Led and supervised clinical programs within Clinical Operations and Scientific Leadership, ensuring compliance with quality standards, regulations, and budget
• Primary oversight of all aspects of project delivery, project quality and financial accountability and managing the Sponsors expectations in all areas for assigned project or program
• Work directly with the Business Development (BD) team on all proposals and pricing related to allocated projects
• Provides regular reporting on project metrics, status of deliverables and risks/issues with the associated management plan to client
• Leads and directs cross-functional team leaders and third parties/vendors and establish and maintain a culture focused on high performance
• Ensure allocated staff are working as a cohesive team and an effective team communication plan is in place
• Guides and supports team leads in prioritizing, trouble-shooting and contingency planning

Achievements:

• Secured multi year service contract for additional studies within the assigned cardiovascular program improving topline growth
• Transformed the EU regulatory and start up to be more metrics driven by galvanizing and enabling a team of CTMs and Start Up PMs facilitating the successful EU CTR submissions and timely approval of new awards
• Facilitated the delivery of robust trainings to Project Managers, Clinical Operations and Business Development teams on the EU CTR requirements
• Engaged with internal stakeholders and external partners to communicate clearly defined processes and workflows, and risks to ensure full compliance under the EU-CTR
• Supported BD and proposals team with the revision of budget algorithms to take into consideration the new EU CTR submission requirements and UK Combined Submissions
• Developed PM tools and training materials for GC's Project Leads Fundamental Trainings
• Designated EU Trainer for EU Project Leads and CTMs, and successfully delivered 10 PM training sessions for EU staff with focus on financial stewardship and key project lead competencies

• Company Overview: PRA Legacy
• Delivered projects on time, on budget and to client expectations and appropriate quality standards
• Ensures project team has relevant strategies in place to maintain bid profitability
• Served as the primary liaison with the client and manages client contractual, organizational and relationship needs/expectations
• Contributed to positive team dynamics through active effective listening and communication including interactive participation in team meetings, sharing of information and proactive problem identification/solving
• Led and directed cross functional team leaders and third parties/vendors
• Managed all project contractual deliverables through review of project progress, monitoring of dashboards/metrics, and proactive identification, resolution/mitigation, and escalations of risks and/or issues
• Serves as a point of escalation for project teams
• Managed project costs and ensures resources are in line with budget and deliverables
• Participated and led the project teams in bid defense process
• Identified and promoted succession planning for assigned staff working with functional management to promote individual development and supportive team dynamics
• Served as deputy/ cover for the Director of Project Delivery

Achievements

• Successfully mentored talented individuals from external roles to progressed into Junior PM via the PRA PM Academy Program
• Through development of mentoring plan and project shadowing
• PM academy instructor: delivered Financial Management Mindset and Scope Management trainings
• Consistently ensured the execution of assigned clinical projects/programmes in compliance with quality standards, established timelines, and budget, and for the oversight of Strategic Partners and other vendors to meet PRA's obligations described in ICH-GCP, local regulations

• Primarily responsible for the oversight and execution of large complex studies or program or portfolio of studies
• Project includes a large cardiovascular study involving 461 sites across the NA, LATAM and EU regions
• Provided oversight to a group of PMs who are managing projects ranging in size and complexity involving full scope, multiple protocol projects
• This includes managing the scope of work, objectives, quality, resources, risks and other project management activities
• Drove the management of the executed contract and financial aspects of assigned projects including review of study budgets along with the Global Project Lead and expenses
• Led and ensure consistency in contingency planning and risk mitigation strategies to ensure successful delivery
• Drove performance improvement, process optimization, and operational efficiencies
• Expected to support and led the operational contributions to proposal development and business development activities at project level
• Provided Line Management to APDs/ Sr PMs
• Participated in PM and PD selection and onboarding of new PMs/ PDs

Achievements

• Led global company initiatives through participation in pilot projects enabling the development of training tools and delivery of project essential trainings to Financial Analysts and Project Management teams on the use of Clinical dashboards and finance and bridging tools for monthly project reviews
• Tapped as an expert in the development and deployment of tools to generate/ automate weekly executive summaries for clients and SynH Executives and Business Unit Leaders
• Supported the hiring of new and talented PMs and Associate Project Directors through active participation during interviews and de-brief meetings, providing robust assessment of applicants performance during the case study presentation

• Provides strategic and operational leadership in driving the end- to end global operation of a large Phase III Program comprising of 3 Chronic Kidney Disease Studies that involves a team of 2 Global Project Leads, 3 Regional PMs, 10 LCRAs, 5 Project Assistants and 30 CRAS, 20 CMAs
• Oversees interdisciplinary clinical research studies and/ or programs ensuring compliance with GCP, relevant SOPs and regulatory requirements
• Ensure delivery of clinical project commitments on time, within budget and in compliance with contract, regulations and SOP
• Acts as primary liaison and/ or facilitator between Synh and Customer to ensure project launch, conduct, and close out according to the Customer's and SynH contractual agreement
• Serve as escalation point, develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals
• Identifies and implements performance improvement and operational efficiencies
• Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports
• Participate in global improvement groups, training newcomer managers and monitoring forms revision committee
• Business Development: develops and maintain relationship with current and prospective clients to continue to generate business
• Supports the business development by providing relevant information on Company and therapeutic capabilities to develop budgets and scope of work
• Successfully oversaw multiple complex clinical studies from initiation to closeout, ensuring compliance with global regulations, company standards, and study timelines
• Led cross-functional study teams to achieve objectives on time and within budget, promoting collaboration and communication
• Developed strategic plans for study execution, including risk management strategies, and fostering strong stakeholder relationships to facilitate regulatory compliance and enhance study quality

• Lead and guided cross functional global teams for the execution and oversight of high profile Oncology Trials (Multiple Myeloma and NSCLC studies) across multiple regions, >100+ across NA, LATAM, EU and APAC regions
• Ensure that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices
• Develop and executed 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 continuously improved and reporting schedules are adhered to
• Develop proactive contingency plans to mitigate clinical risk
• Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans
• Escalate findings and action plans to appropriate parties
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles
• Participate in proposal development
• Lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff
• Provided oversight on cross-functional teams, including clinical operations, data management and regulatory affairs (etc.) to achieve project goals and ensured that activities were carried out in accordance with standard procedures and processes, leading to improved operational efficiency and consistency in project delivery
• Successfully led and managed multiple clinical projects simultaneously, ensuring they are completed on time, within budget, and meet quality standards leading to high client satisfaction and repeat business opportunities
• Proactively identified, resolved, and escalated project/program risks and issues, ensuring adherence to protocols, regulations, and ICH-GCP guidelines, and maintaining compliance and data integrity throughout the project lifecycle

• Manage the execution of the clinical component of large, global complex study protocols/ global projects in in the areas of renal failure, and oncology in accordance with the scope of work, contracted timelines and study budget
• Lead and mentored a group of regional CTLs assigned to the same project
• Establish appropriate clinical tools and processes for the study team to support the execution of clinical deliverable and study timelines
• Manage clinical study set-up and follow-up study activities through ongoing tracking and review of study progress
• Report progress to appropriate clinical management and project management forums
• Collaborate with other functional groups within the company such as data management, pharmacovigilance, and biostatistics where necessary to support milestone achievement and to manager study issues and obstacles
• Develop the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution with the Project Manager
• Develop proactive contingency plans to mitigate clinical risk
• Identify quality issues within the study through regular review of the clinical team communications including site communications, monitoring visit reports, data flow information and quality assurance audit findings

• Manage a group of Clinical Team Leaders and Senior CRAs in accordance with organization's policies and applicable regulations
• Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems
• Participate in the selection and onboarding process for new clinical staff by conducting candidate review and participating in the interviewing process
• Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs
• Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training
• Manage the quality of assigned staff's clinical work through regular review and evaluation of work product
• Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management

• Assigned as the Global Clinical Team Lead for a large renal failure study and accountable for achieving the final clinical deliverable within the time period specified in the contract with the clients and within budget
• Responsible for the overall coordination and management of global and regional clinical trials from start up through close out across countries in Asia Pacific
• Direct technical and operational aspects of the project to ensure compliance with ICH GCP, FDA CFR, QUINTILES and client's SOP
• Work across functional areas to identify and evaluate any issues, interpret data and implement solutions in order to ensure successful completion of trials
• Oversees project specific training for project team members and identifies and performs any required trouble shooting activities
• Develops Clinical tools e.g
• Monitoring Plan, Monitoring Guidelines in conjunction with Data Quality Plan
• Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team
• Built a high performing team of CRAs, Sr
• CRAs and Junior CTMs, maximizing performance and improving employee engagement
• Zero resignations during this period, 4 promotions of Sr
• CRAs to CTMs during my tenure as Line Manager

• Company Overview: Local CRO partner of Parexel in APAC
• Set up the Philippine office of Apex Pharmaceutical (later on acquired by Parexel) through securing business by setting up multiple high performing clinical trial sites and continued support of business development activities/ initiatives
• Built a high performing team of CRAs, Sr CRAs and Clinical Trial Assistants and grew the team to 12 headcounts in a span of 1 year
• Served as the primary decision-maker for a clinical study, ensuring alignment with objectives and regulatory requirements, and overseeing all study management aspects
• Directed the study team in executing activities, monitoring progress, and addressing issues to maintain study timelines and quality