Experience

Belite Bio

• United States
• Biotechnology Research
• 1 - 100 Employee

• Clinical Project Manager

  • Feb 2023 - Present

  - Provide sponsor oversight for two (2) Phase 3 global clinical trials - Collaborate with investigative sites, CROs, and vendors to ensure timely subject enrollment and study deliverables - Serve as primary point of contact for study communications - Conduct weekly meetings to discuss study progress - Provide sponsor oversight for two (2) Phase 3 global clinical trials - Collaborate with investigative sites, CROs, and vendors to ensure timely subject enrollment and study deliverables - Serve as primary point of contact for study communications - Conduct weekly meetings to discuss study progress



Lexitas Pharma Services

• United States
• Research Services
• 100 - 200 Employee

• Senior Clinical Study Manager

  • Aug 2022 - Jan 2023

  • Serve as a study contact for Sponsor and project vendors • Provide oversight to CRAs and CRCs in the planning, implementation, and closeout of clinical research projects. Serve as a point of contact for issue escalation • Develop or oversee development of key study documents, including but not limited to, Clinical Management Plans, Monitoring Plans, Informed Consent Forms, Case Report Forms, Study Reference Manuals/Regulatory Binders, and source document templates • Review or oversee review of monitoring visit reports • Manage vendors, including the implementation and coordination of vendor’s Scope of Work (SOW) • Manage study budget and timelines. Identify, resolve, or escalate issues involving study timelines and deliverables • Develop, implement, and oversee enrollment plans and strategies • Oversee system development, ensuring suitable fit for the protocol • Collect, track and report established Key Performance Indicators such as query resolution, safety data collection or issues, drug reconciliation/shipment, site and patient enrollment, protocol deviations • Identify and establish the suitability of study investigators and their investigative sites and liaise with them to ensure compliance with all necessary study requirements, approvals, and agreements (e.g., financial and confidential) • Ensure study conduct in accordance with appropriate SOPs, ICH/GCP Guidelines and local regulations Show less



Promedica International, A California Corporation

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Project Manager

  • Dec 2019 - Aug 2022



Allergan

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Assoc., Clinical Trial Manager

  • Jun 2019 - Dec 2019



City of Hope

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Manager, Multicenter Research Operations

  • Jun 2018 - Apr 2019

  Provided leadership as well as operational and general oversight of City of Hope’s (COH) Multicenter Research to ensure standardized practices are compliant with all institutional and regulatory requirements. Oversaw a team of Multicenter Clinical Research Monitors in monitoring and managing the timely study planning, start up, administration, and close-out of City of Hope initiated clinical trials conducted at COH and participating institutions. • Led the day to day operations and provided guidance to the Multicenter Research Operations (MCRO) team in proactively identifying and implementing solutions to improve efficiency, effectiveness, and timeliness of the activation of clinical trials at COH and outside cancer centers, as well as study compliance through effective and robust study monitoring. • Participated in cross-functional teams for protocol review, case report form development, safety reporting, safety monitoring, and deviations management. Served as the CAPA Lead in response to Corrective Actions and development of Preventative Actions. • Liaised cross-functionally with the Clinical Trials Office, Office of Clinical Trials Auditing and Monitoring, Office of Regulatory Affairs, Clinical Research Regulatory Support Services, Clinical Trials Support Services (Contracts Team), Clinical Trials Billing, Quality Assurance, Data Safety and Monitoring Committee, Office of IRB, Systems Informatics (CRF Development Team), and OnCore Support Team. • Collaborated closely with the Director of Safety and Data Quality in developing SOPs, guidance documents, work instructions, and tracking tools and metrics related to the data and safety monitoring of multicenter trials. • Recruited, hired, and trained new staff and provided the necessary development plan and executed disciplinary action, where applicable. Show less



Doheny Eye Institute

• United States
• Non-profit Organizations
• 100 - 200 Employee

• Manager, Project Management (Clinical Operations)

  • Jan 2016 - Mar 2018

  Lead, supported, and mentored the Project Management Team in the timely delivery of quality data for Phase I, II, and III Ophthalmic Clinical Trials while meeting or exceeding client expectations and maintaining positive relationships. (Held an interim dual role of Manager, Project Management and Operations for a period of 6 months.)• Provided oversight to a team of 12 Project Managers in clinical trials set-up, maintenance, and close-out activities.• Responsible for interviewing, hiring, and training Project Managers. Performed annual performance assessments, developed improvement plans for staff on probation due to performance/behavioral issues, provided counseling, and executed staff termination.• Collaborated cross-functionally with Technical Development, Compliance, Quality Assurance, and other stakeholders to design an in-house web-based database (ARCOS - Application for Reading Center Operations and Submissions) that allowed clinical sites to submit study materials electronically and enabled digital receipt, processing, assessment, and reporting of study-related materials. ARCOS resulted in the workflow’s transition from a paper-based system to an electronic system.• Spearheaded Operational Excellence projects to standardize processes and re-vamp departmental and global Standard Operating Procedures (SOPs) and Work Instructions (WIs).• Worked with Operations, Quality Assurance, and Compliance to ensure appropriate checks and balances were in place, adequate resources were available, staff training requirements were current, and GCP/GDP requirements were met. • Negotiated milestones and deliverables with sponsors and CROs with SMART goals in mind. • Designed continuous education training programs and conducted training for various departments. Show less

• Project Manager

  • Sep 2013 - Jan 2016

  Clinical Trials Management in the field of Ophthalmology – A blend of project management, clinical study coordination, client services, and leadership. • Managed multiple Phase I, II, and III Clinical Trials (start to finish oversight) – study set-up, maintenance, and close-out. Served as point of contact for sponsors, clinical sites, investigators, and monitors. • Study Set-up: Reviewed Clinical Protocol, SOW, and budget; scheduled initial teleconference with sponsor to review key study aspects, finalized grading variables, and established communications plan; created project plan and tracking tools; developed study materials (Site Instruction Manual for clinical sites, Project Specific Manual of Procedures, Study Specific Grading Protocol, grading worksheets, and study forms); collaborated with sponsor’s data manager in the development, review, and testing of the eCRF/EDC system; and prepared presentation for kick-off meeting. • Study Maintenance: Monitored status of study progress; maintained study budget; provided budget forecasting to sponsor; performed monthly reconciliation and billing; managed contract amendments; delivered image deliverables and reports to sponsor; updated study materials as needed; hosted sponsor and monitor visits; scheduled conference calls and prepared meeting minutes; provided ongoing direction to study coordinators in the performance of study-related tasks; resolved queries; identified and addressed non-conformances; organized files for interim data locks; and ensured audit-readiness of Trial Master Files.• Study Close-out: Developed Image/Data Transfer Agreement and Project Close-out Plan; performed full study reconciliation; prepared study materials for long-term off-site archival; performed data transfer for final data lock; and prepared final study invoice.• Trained and mentored new Project Managers and coordinated cross-training for existing Project Managers. Show less



Allergan

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pharmacovigilance Specialist (Consultant)

  • May 2012 - Apr 2013

  Processed SAEs and non-SAEs in the ARGUS Safety Database for post market and investigational products being assessed in clinical studies in accordance with FDA, EMA, and ICH guidelines. Responsible for safety reporting of ophthalmic products and Botox. • Provided preliminary triaging of incoming safety reports and performed follow up activities with local affiliates, consumers, and healthcare professionals. • Responsible for accurately processing SAEs and non-SAEs that included writing case narratives, assessing listedness of event terms, and reporting to local and foreign health authorities. • Prepared submission records and provided support for the reconciliation of data in the Argus Safety Database. Show less



Actavis plc (now Allergan)

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Drug Safety Associate (Consultant)

  • Jul 2011 - Sep 2011

  Drug Safety Associate – Consultant (JUL 2011 – SEP 2011)Evaluated post market compliance reports and analyzed the seriousness criteria of adverse events based on FDA guidelines for reporting of individual case safety reports (ICSRs). Responsible for safety reporting of oral contraceptives.• Analyzed and processed product complaints for the fulfillment of regulatory reporting responsibilities by corresponding with patients/complainants, evaluating the seriousness of adverse events, writing case narratives, sending requests for investigations, and preparing correspondences and reports. • Served as a core member of the FDA Compliance Team. Assisted with audit preparations, performed transcription of notes for the FDA audit, and revised SOPs in response to CAPAs. Show less

• Project Coordinator

  • Jan 2010 - Jul 2011

  Developed project plans in support of Operational Excellence projects for Quality Operations and Laboratory Operations. Executed product launches, conducted weekly meetings, and measured performance against timelines. Prepared metrics and presented presentations at stakeholder meetings.• Coordinated team of chemists in development of reference standards in-house that resulted in control of turn-around time, eliminated need to outsource materials, and provided cost savings of $600K annualized.• Established time management study to reduce cycle time in completing change controls, closing deviations, and meeting FDA compliance deadlines for completion of CAPAs.• Created laboratory workbook template for recording laboratory data to reduce documentation time, improve clarity, and provide consistency in method of data collection, resulting in 75% reduction of documentation time.• Wrote SOPs and prepared change control forms. Show less

• Corporate Quality Systems Coordinator

  • Aug 2007 - Jan 2010

  Managed workflows for the approval and archival of R&D’s Test Methods and SOPs. Provided Quality Assurance support to R&D’s product launches.• Performed final review of QA reports and R&D’s Test Methods, and managed workflows via LiveLink (electronic data management system) to make documents effective or obsolete.• Wrote departmental and global SOPs. Facilitated and managed departmental training and maintained rate of 100% compliance with SOP, cGMP, and other regulatory requirements.• Formulated Excel spreadsheets to track performance and prepared monthly metrics for senior management. Show less

• Executive Assistant

  • Apr 2005 - Aug 2007

  Performed administrative functions to support Executive Vice President, 2 Senior Vice Presidents, Executive Director of Project Management, and team of 7 Project Managers in Technical Operations.• Scheduled meetings and events, organized logistics, and prepared meeting materials and PowerPoint presentations.• Provided support in scribing meeting minutes at Leadership Meetings.• Processed confidential and sensitive documents at an executive level.• Prepared expense reports and maintained department budget. Show less



Elan Pharmaceuticals

• Ireland
• Biotechnology
• 300 - 400 Employee

• Senior Study Financial Coordinator

  • May 2003 - Apr 2005

  Negotiated and managed contracts/budgets for Phase I, II, and III Clinical Trials and served as liaison between Clinical Operations, Regulatory Affairs, Medical Affairs, Legal, Finance, Purchasing, and Investigator Sites. Therapeutic areas included Cardiovascular, Rheumatoid Arthritis, Neurology, and Crohn’s Disease.• Generated clinical trial agreements, developed study protocols and related documents, and managed study budgets and timelines.• Analyzed outsourcing contracts and developed comparison tables to optimize fee-for-service, resulting in a streamlined list of preferred CRO vendors.• Managed CRO performance and liaised with Legal and other departments as needed to resolve compliance issues.• Facilitated Clinical Steering Committee Meetings and served as point of contact for key opinion leaders and stakeholders. Show less

• Clinical Operations Associate

  • May 2002 - May 2003

  Managed CRO and Clinical Site contracts for Phase I, II, and III Clinical Trials. Responsible for overseeing budget across all studies.• Prepared agreements and budget for initiation of Clinical Site start-up activities.• Reviewed CRO vendor proposals and made recommendations based on fee-for-service options and Scope of Work.• Coordinated payment of expenses to CROs and Clinical Sites for the duration of clinical trials.

• Clinical Operations Assistant

  • Nov 2001 - May 2002

  Provided general support to the Clinical Operations department and assisted in the establishment and maintenance of contracts with Clinical Sites for Phase I, II, and III Clinical Trials.• Corresponded with Clinical Trial Managers, Clinical Research Associates, Legal, Finance, Purchasing, and Clinical Sites to establish clinical trial agreements and related costs.• Coordinated with Purchasing and Accounting to ensure timely payment to Clinical Sites and outsourced vendors per contract terms.• Performed data entry of study participants for various Clinical Studies and tracked study budgets. Show less



Madison Square Properties

• Property Manager

  • Aug 1997 - Sep 2001

  Collaborated with property owners, brokers, attorneys, lenders, and vendors in managing 2.5 million square feet of commercial properties. • Negotiated contracts and established preferred vendor list, delivering quality service at optimal cost. • Handled general correspondence concerning lease terms, complaints, requests, repairs, etc. • Reconciled monthly statements and prepared profit and loss statements. • Generated invoices, processed payments, and resolved delinquencies and tenant default with attorneys. Show less