Olivia Oliveros-Cuenco
Dixon,CA
Summary
Experienced clinical research professional with expertise in overseeing operations across teams and stakeholders. Skilled in process optimization, performance management, and strategy implementation to enhance efficiency and reduce costs. Proven leader in team motivation, strategic planning, and conflict resolution, driving successful project outcomes.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Sr. Clinical Trial Leader
Genentech, Inc.
South San Francisco, USA
07.2020 - Current
- Participate in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICF), protocols, site and country budget templates, electronic data capture (EDC), interactive response technology (IRT), central/specialty lab, electrocardiogram (ECG/EKG), imaging, and patient reported outcome (PRO) specifications, drug supply and biomarker/sample management plans, trial master file (TMF), and clinical study report (CSR)
- Liaised with cross-functional team members, including Study Management Team (SMT), to gather input for project alignment
- Draft and implement study plans, including vendor oversight, risk, quality, safety, communication
- Lead a Phase 2 Oncology trial
- Contributed clinical operations expertise to Medical Plans and study design, enhancing overall study strategy
- Managing assigned clinical trial operations, and assuming accountability for such, to ensure delivery of operational activities to meet Study Plans outlined in Medical Plans
- Provided leadership and direction to SMT, ensuring clarity in project goals and team alignment
- Providing Contract Research Organization (CRO) and other vendor oversight
- Ensuring assigned SMT and vendor partners deliver on commitments to agreed targets
- Ensuring study adherence to budget, ICH-GCP standards, Genentech/Roche SOPs and other operating guidelines and regulatory requirements
- Compliantly developing and cultivating productive relationships with external partners/stakeholders
- Contributing to study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting continuous improvement
- Driving and making clear decisions in the project team environment
- Track budget, timelines, milestones, and critical study activities; identifying issues and proposing potential resolutions
- Partner closely with medical colleagues to provide strategic operational input on protocol feasibility
- Provide input into the study budget and manage assigned vendor budget(s); communicate variances in actual versus forecasted spend in vendor budgets and present an action plan for resolution
- Participate in selection of vendors (participate in the Request for Proposal [RFP] process)
- Utilize outputs from operational analytical tools to enhance and improve study execution
- Oversee delegated outsourced activities to ensure CRO and vendor delivery against contracted scope of work
- Contribute to study site selection and management
- Oversee protocol, country, and site feasibility assessments
- Assist with all activities related to site selection, contracting, set-up and maintenance
- Partner with Site Contracts on development of site budget template and budget negotiations
- Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness
- Ensure accuracy and timeliness of CTMS, timeline planning tools and other core systems
- Ensure study adherence to ICH/GCP and SOPs
- Stay current on relevant therapeutic knowledge and clinical research best practices
- Provide support, mentoring and study-specific training to other U.S. Medical Clinical Operations team members
- Served as subject matter expert on task forces, initiatives, and various working groups
- Core team member for the A.I.R. (Advancing Inclusive Research) Site Alliance Committee
- U.S. Medical Business Unit Lead for A.I.R. Site Alliance
- Served as primary contact for City of Hope within the A.I.R. Site Alliance, facilitating communication and collaboration.
- Oversaw patient education initiatives for the A.I.R. Site Alliance, enhancing participant understanding of clinical trials.
- A.I.R. Core Team Member of the Patient education and Healthcare Provider (HCP) education working groups
- Help develop company sponsored patient and Healthcare Provider (HCP) education resources for the A.I.R. Site Alliance
- Lead and motivate team of employees, achieving goals through collaborative efforts
- Monitor and provide feedback to the team on job performance, disciplinary issues and team objectives
- Make data-driven decisions under pressure, considering various perspectives and potential outcomes
- Develop and implement strategic plans, aligning team goals with overall company objectives
- Build positive, inclusive work environment where team members feel valued and supported
- Present ideas persuasively to stakeholders, securing buy-in and resources for strategic initiatives
- Communicate vision, goals, and expectations clearly and concisely to the team, fostering engagement and alignment
- Delegate tasks strategically based on team member strengths, fostering individual growth and development
- Provide ongoing coaching and feedback, empowering team members to excel and reach full potential
- Cultivate culture of high performance, accountability, and continuous improvement
- Facilitate productive discussions to reach consensus and resolve complex issues effectively
- Set performance goals for staff members and helped teams meet important deadlines
- Streamline workflow processes to reduce costs and improve productivity
- Conduct employee evaluations and documented overall progress
Study Management Associate III
AbbVie Inc.
North Chicago, USA
01.2018 - 06.2020
- Asia-Pacific and Europe Regional Lead for a Phase 3 Global Immunology trial
- Study Lead for a Phase I Global Immunology trial
- Coordinated cross-functional team activities, ensuring timely initiation and completion of start-up activities
- Supported the development of the clinical study design and associated systems and documents (for example: source documents, Study Specific Language [SSL], EDC, IRT)
- Developed study-related training for the study team, study sites, and vendors
- Identified and escalated study-related issues and opportunities, enhancing operational efficiency
- Updated cross-functional teams and stakeholders on study status, facilitating informed decision-making
- Led Site Feasibility and helped support site identification/selection activities
- Managed the clinical schedule, critical path and milestones
- Actively participated in vendor selection activities and scope development
- Reviewed and approved invoices related to the clinical study budget.
Study Management Associate III
AbbVie Inc.
North Chicago, USA
05.2016 - 12.2017
- Australia and Asia-Pacific Regional Lead for a Phase 3 Global Oncology Trial
- Led the coordination of activities of a cross-functional team to ensure initiation and completion of start-up activities
- Managed ICF review/approval process and IRB submissions at country and site levels, ensuring compliance and timely approvals
- Ensured inspection readiness at all times by providing TMF quality control checks and oversight; worked closely with our affiliates to ensure essential study documents were filed timely and accurately
- Supported review and data cleaning activities for Asia-Pac, contributing to 50% of overall study enrollment in preparation for interim data monitoring committee (IDMC) meetings
- Actively participated in weekly internal team meetings by providing key study updates
- Facilitated bi-weekly teleconference affiliate team meetings
- Vendor management and oversight (training, issue identification/escalation and SOP compliance)
- Coordinated with external vendors to ensure timely delivery of goods and services
- Ensured vendor contracts aligned with organizational standards
- Reviewed forms, emails and correspondence to facilitate proper routing and data integrity
Sr. Clinical Trial Management Associate
Gilead Sciences Inc.
Foster City, USA
02.2016 - 04.2016
- North America Regional Lead for a Phase 3 Global Oncology Trial
- U.S. Site Lead
- Led site start-up activities for the randomized phase
- Managed ICF review/approval process and IRB submissions, ensuring compliance at country and site levels
- Actively participated in weekly CRO meetings by providing key study updates
- Reviewed pre-study site visit (PSSV) reports and was responsible for site selection
- Reviewed and approved start-up packages, streamlining site activation process
- Provided back-up support for the Clinical Trial Manager by facilitating Dose Escalation Teleconferences and SMT meetings
- Vendor management and oversight (training, issue identification/escalation and SOP compliance)
- Engaged in the Tools and Training Initiative to assist in developing study tools such as the RECIST 1.1 Toolkit.
- Worked with the Clinical Contracts and Finance group to address site contracts and budget issues.
- Participated as a presenter at the North America Investigator Meeting
- Coordinated with external vendors to ensure timely delivery of goods and services
- Reviewed forms, emails, and correspondence to ensure accurate routing and maintain data integrity
Clinical Trial Management Associate
Gilead Sciences Inc.
Foster City, USA
12.2013 - 02.2016
- Lead CTMA for a Phase 1b and Phase 2 Global Oncology trial
- Actively contributed to achieving study timelines by ensuring deliverables were completed in a timely manner
- Coordinated site selection, study implementation, and ongoing study site management, directly or via CRO.
- Coordinated the site feasibility assessment process to identify suitable study sites.
- Developed Study Start-Up documents (Site Feasibility Questionnaires, subject materials, study binders, etc.).
- Directed the development and finalization of informed consent forms (ICFs) for studies.
- Conducted review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and study management plans
- Reviewed protocols, informed consents, and case report forms, monitoring plans, Important Protocol Deviation (IPD) plans, Dose Escalation plans, study documents, training and presentation materials
- Closely interacted with investigators and site staff by providing protocol clarification and issue resolution
- Resolved administrative issues by engaging with vendors and applying independent judgment.
- Performed routine data review and escalated issues identified to CRAs and to the Data Management team for timely resolution
Education
Post-Bacccalaureate Program -
University of California, Davis
Davis, CA06-2007
Bachelor of Science - Biology
St. Mary's College of California
Moraga, CA06-2002
Skills
- Clinical trial management
- Protocol development
- Study design
- Regulatory compliance
- KPI development
- Budget management
- Vendor oversight
- Project management
- Contract management
- Risk assessment
- Risk mitigation
- Continuous improvement
- Process improvement
- Performance management
- Operations management
- Workflow management
- Issue resolution
- Incident resolution
- Decision-making
- Negotiation skills
- Strategic planning
- Objectives planning
- Stakeholder engagement
- Cross-functional collaboration
- Financial acumen
- Expense control
- Data analysis
- Documentation and reporting
- Team leadership
- Staff management
- Talent development
- Line management
- Team motivation
- Change management
- Relationship building
- Quality control
- Effective communication skills
- Problem solving skills
Certification
- Phlebotomy Training
- Medical Assistant
References
Available upon request.
Publications
- Variance of Pain Prevalence and Associated Severity during the Transfusion Cycle of Adult Thalassaemia Patients., Green, Sage T., Marie B. Martin, Dru Haines, Susan Carson, Thomas Coates, Olivia Oliveros, Eric Gerstenberger, Felicia Trachtenberg, Janet L. Kwiatkowski, British Journal of Haematology, 166, 5, 2014, 797-800, https://doi.org/10.1016/j.cct.2023.107416
- Pain over Time and Its Effects on Life in Thalassemia., Oliveros, Olivia, Felicia Trachtenberg, Dru Haines, Eric Gerstenberger, Marie Martin, Susan Carson, Sage Green, Diane Calamaras, Pauline Hess, Robert Yamashita, Elliott Vichinsky, American Journal of Hematology, 88, 11, 2013, 939-43, https://doi.org/10.1016/j.cct.2023.107416
- Pain in Thalassaemia: The Effects of Age on Pain Frequency and Severity., Haines, Dru, Marie Martin, Susan Carson, Olivia Oliveros, Sage Green, Thomas Coates, Jennifer Eile, Leann Schilling, Bogan Dinu, Tito Mendoza, Eric Gerstenberger, Felicia Trachtenberg, Elliott Vichinsky, British Journal of Haematology, 160, 5, 2012, 680-87, https://doi.org/10.1016/j.cct.2023.107416
- Use of Electronic Data Collection to Assess Pain in Thalassaemia: A Feasibility Study., Trachtenberg, Felicia L., Marie Martin, Sage Green, Olivia Oliveros, Susan Carson, Eric Gerstenberger, Racquel Allen, Jennifer Eile, Dru Haines, International Journal of Palliative Nursing, 18, 9, 2012, 441-45, https://doi.org/10.1016/j.cct.2023.107416
Awards And Acknowledgements
Advancing Inclusive Research (AIR) Site Alliance: Facilitating the inclusion of historically underrepresented people in oncology and ophthalmology clinical research, Gregory A. Vidal, Patricia Chalela, Andrea N. Curry, Bassel El-Rayes, Balazs Halmos, Alex F. Herrera, Kapil G. Kapoor, Supreet Kaur, Daruka Mahadevan, Ruben Mesa, Amelie Ramirez, Barry Sleckman, Alan L. Wagner, Ruma Bhagat, Isabel Brown, Leia Cruz, Audrey Funwie, Quita Highsmith, Nicole Richie, Meghan McKenzie, Contemporary Clinical Trials, 137, 2024, 107416, 1551-7144, https://doi.org/10.1016/j.cct.2023.107416
Timeline
Sr. Clinical Trial Leader
Genentech, Inc.
07.2020 - Current
Study Management Associate III
AbbVie Inc.
01.2018 - 06.2020
Study Management Associate III
AbbVie Inc.
05.2016 - 12.2017
Sr. Clinical Trial Management Associate
Gilead Sciences Inc.
02.2016 - 04.2016
Clinical Trial Management Associate
Gilead Sciences Inc.
12.2013 - 02.2016
Post-Bacccalaureate Program -
University of California, Davis
Bachelor of Science - Biology
St. Mary's College of California