Mary Anne Osorio - Senior Project Manager, Pi Health Inc

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Work Background

Pi Health Inc. (PiVOT)Senior Project Manager

Jul. 2024Pasig, National Capital Region, Philippines• Lead and manage multiple complex clinical trials simultaneously, ensuring successful execution from initiation to close-out • Develop and implement project plans, timelines, and budgets in collaboration with sponsors and internal teams • Monitor project progress, identify and mitigate risks, and implement corrective actions as needed • Conduct regular project team meetings and provide status updates to stakeholders • Serve as the primary point of contact for sponsors, maintaining strong relationships and ensuring client satisfaction • Manage sponsor expectations and negotiate project changes when necessary • Present project updates and results to sponsors and senior management • Lead, mentor, and develop project team members, including CRAs, and other functional specialists • Allocate resources effectively across projects and manage team workload • Conduct performance evaluations and provide ongoing feedback to team members • Ensure all projects adhere to ICH-GCP guidelines, local regulations, and company SOPs • Oversee the development and implementation of risk management strategies • Collaborate with Quality Assurance to prepare for and manage audits and inspections • Financial Management • Develop and manage project budgets, ensuring profitability and cost-effectiveness • Monitor and control project expenses, providing regular financial updates to management • Identify and pursue opportunities for process improvement and cost savings • Contribute to proposal development and bid defense presentations • Participate in client meetings and presentations to support business development efforts • Provide input on feasibility assessments for potential new projects

Pi Health Inc. (PiVOT)Senior Quality Assurance Officer

Jul. 2024• Serve as a Senior Quality Assurance Officer, overseeing quality standards across multiple projects • Conduct quality oversight reviews of project documentation and processes • Develop and implement organization-wide quality processes and procedures development/updates with personnel training on time • Collaborate with the Quality Assurance Manager to enhance and standardize quality processes • Develop and implement organization-wide Corrective and Preventive Action (CAPA) plans • Monitor and track CAPA effectiveness across projects • Lead the preparation, management, and follow-up of audits and inspections • Establish and maintain quality metrics reporting systems

FortreaClinical Operations Manager II

May. 2019 - Nov. 2023Philippines• Has regulatory oversight of direct reports by ensuring regulatory training is executed, understood and implemented • Escalate issues and follow them till proper resolution • Ensures training record compliance with training matrix and ensures training records are up to date • Provide input to relevant SOPs and standard plans/templates when applicable • Assist with coordination and implementation of on-boarding of new direct reports ensuring GCP training before study-related activities begins • Hold staff accountable for issue escalation to the management team, the sponsor and QA, as appropriate and determine regional implications for corrective action plans • Hold staff accountable for quality and compliance with project plan and adherence to contract obligations • Coach staff to own effective Investigator relations and Investigator oversight when applicable • Report status of assigned workload of direct reports and ensure allocation reports are updated • Perform weekly review of direct report billable hours and utilization (in context of project allocation, supply and demand); escalate of outliers and assists management team for mitigation • Adheres to global tools for monitoring and utilization forecasting • Assist with staff recruitment through screening and interviewing • Financial authority in accordance with current signature approval matrix • Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports • Liaise with internal and external customers in relevant process improvement initiatives • Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity • Support the company/department processes (e.g. Quality Control Visits) • Identify, develop, and implement measures to improve the efficiency of the department • Responsible for staff time management, PTO and salary reviews • Might be requested to work in a client facing environment

Integrated Development Associates Co. Ltd.Manager Quality Management

Dec. 2017 - Apr. 2019Manila Responsibilities: • Establish and maintain IDA QM Systems and processes including ensuring audit readiness of all key functions, ensure completion of CAPA responses to clients and regulatory authorities • Undertake company-wide planning of necessary training of IDA staff and develop training program, directly and facilitate actual training • Take lead in identifying IDA SOP Development needs and drafting and facilitating finalization of SOPs. • Assist Line Manager in assessing, establishing and documenting IDA company business operational processes including both clinical trial management services, administration and BD. • Ensures all functions are managed pursuant to best practice standards and governmental regulations are followed in a consistent manner. • Responsible for developing, maintaining, adhering and evaluation of systems, processes, policies, and procedures for all quality management and training activities that promote compliance. • Acts as project manager for QM and training related projects. • Monitors processes to ensure compliance with contracting requirements and standards. • Updates and disseminates all forms and documents to maintain compliance with confidentiality/privacy laws and regulations. • Develops, implements and documents internal and external audit processes, which ensure that all procedures are current and accurate. • Planning, conducting, reporting and following up of Internal and Sponsor Audits • Ensure inspection Readiness • Analyze data to identify areas for improvement in the quality system. • Prepare reports to communicate outcomes of quality activities (e.g. CAPA, Audit Reports, etc.) • Coordinate and support on-site audits conducted by external providers. • Provide other assistance as reasonably requested by Line Manager.

Integrated Development Associates Co. Ltd.Clinical Operations Manager

Feb. 2015 - Dec. 2017Muntinlupa City, Philippines• Act as Line Manager to CRAs and Clinical Project Assistants / QC Staff. • Responsible for overall management of the study/ project assigned from start up through study close-out, in compliance IDA processes and regulatory requirements. • Communicates with clients, regulators, CROs and other vendors to ensure the successful conduct of IDA studies. • Develop, review, and/or approve on Informed Consent Form (ICF), Case Report Form (CRF), Data Management (“DM”), and documents used in the study in coordination with the Project Team • Ensure project timelines and quality of deliverables required by the sponsor/ client are met • Oversee of site feasibility and selection process • Assist in regulatory document maintenance including document collection and submission to regulatory authorities and Independent Ethics committee(IEC)/Institutional Review Board(IRB) • Assist in Review labeling for compliance with regulatory requirements • Assist in the Management of a process related the study drug including importation, returning to sponsor or destruction • Provide or facilitate training to clinical study teams on assigned protocol specific topics • Mentoring CRA including training, communication with site staffs and monitoring activities, as necessary. • Responsible for implementation and compliance to key contract provisions while informing management and client for out of scope activities • Communication and collaboration with the internal project team, clients, and vendors providing accurate labor forecasts, reviewing pass-through costs and ensuring timely invoicing • Assist in the management importation/ exportation and accountability of IP and Non-IP clinical materials • Oversee site visit compliance and review site visit reports • Perform co-monitoring visits with CRA as necessary • Perform periodic review of issues to identify any trends for communicating and taking appropriate action with CRA and escalation to Sponsor/ Client and/or QA as necessary

NovotechLead CRA / Senior Clinical Research Associate

Aug. 2013 - Jan. 2015• Acting as a site manager to ensure that clinical trials are conducted and documented as per ICH GCP guidelines, global and local regulatory requirements and Novotech/Client SOP • Providing mentorship to less experienced staff • Providing support to the project manager as required • Performing site selection visits to ensure sites have adequate resources to conduct studies

ReSearch Pharmaceutical ServicesSenior CRA / Local Trial Manager

Apr. 2012 - Aug. 2013• Knowledge of applicable SOPs, guidelines and study procedures. • Assist with protocol and CRF review. • Develop informed consent forms. • Conduct study feasibility and site selection activities. • Assist with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials. • Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities. • Assist with investigator meeting activities. • Conduct site management activities, including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits. • Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines. • Write study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines. • Coordinate timely shipment of clinical supplies and study drug to sites. • Ensure proper storage, dispensation and accountability of clinical supplies and study drug. • Follow up of drug safety issues and safety reports in timely manner, if applicable. • Communicate site study issues, concerns, and progress Project Manager, Clinical Team Lead and Clinical Research Manager accordingly. • Development and implementation of corrective actions when appropriate. • Prepare /review all patients tracking records. • Input and maintain study information concerning subject status of financial reimbursement to sites. • Mentor for CRA I and/or CRA II, when assigned. • Conduct on the job training and formal training to other CRAs and Clinical Trials Assistants. • Collaborate with Clinical Research Manager/ study teams to resolve site issues. • Review study visit reports, follow-up letters and site communication generated by other CRAs for timeliness, quality, consistency, and appropriate documentation and resolution of issues

QuintilesClinical Research Associate 2

Apr. 2009 - Apr. 2012Manila, Philippines• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. • May provide assistance to more less experienced clinical staff

GlaxoSmithKlineClinical Research Associate

Aug. 2006 - Mar. 2009Manila, Philippines• Responsible for the performance of the Vaccine Post-Marketing Surveillance (PMS) studies, and ensures that studies are performed according to quality standards and within timelines • Reviews visit reports prepared by the Clinical Research Associates (CRAs), supervises CRAs to identify and escalate burning issues to upper management (if applicable) and ensures the timely resolution of these issues • Provides coaching and project specific training to CRAs • Proposes workload allocation to the Clinical Operations Manager, and assigns back-up of CRAs • Responsible for over-all tracking of PMS expenditures • Assists the Clinical Operations Manager and Medical Director by providing input to the budget forecasting exercises • Inputs into the periodic review and update of Standard Operating Procedures (SOPs) • Assesses study process and initiates improvement as necessary and shares best practices with the team • Ensures competency of CRAs through joint site visits • In collaboration with the Local Trainer, identifies individual/team training needs • Monitors PMS studies according to protocols, respecting Good Clinical Practice (GCP)/international Conference on Harmonisation (ICH) guidelines, GSK and specific GSK Biologicals SOP and provides accurate and valid data for further statistical evaluation and clinical report

Bureau of Food and Drugs (BFAD)Drug Evaluator

Jul. 2005 - Jul. 2006