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Work Background
ICON plcManager, Clinical Trial Management
Sep. 2023Lead and effectively line manage a group of global Clinical Trial Managers (CTMs) of various levels of seniority in multiple locations, to ensure appropriate performance in line with objectives, resourcing, and career development of CTMs and Sr. CTMs. Regular oversight of key clinical metrics, including but not limited to: Days on Site (DOS), Monitoring Visit reports (MVR) and Follow up Letters (FUL) timelines, Action Items (Al) and other quality metrics, to ensure they are met. Responsible for planning, scheduling and implementing the clinical aspects of projects in line with contract and budget, e.g., implementation of protocol and amendments, IP management, investigator payments, etc. Primary point of contact clinical aspects of designated projects, responsible for developing successful cross-functional relationships with internal/external stakeholders. Regular oversight of key clinical metrics, including but not limited to: Days on Site (DOS), Monitoring Visit reports (MVR) and Follow up Letters (FUL) timelines, Action Items (Al) and other quality metrics, to ensure they are met and followed-up as necessary. Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders. May act as the primary point of contact for smaller or single service projects. To work on multinational studies or take the role of a Global CTM. Responsible for coordinating, managing and mentoring the clinical project team to ensure high performance and productivity (e.g., Days on Site for CRAs), optimal utilization, continuous development and minimal turnover.
ICON plcClinical Trial Manager II
Mar. 2021 - Aug. 2023Acting as the functional lead from clinical operations with oversight of, and overall accountability for site selection; Site start up (including submissions and Investigator contract negotiation); Patient recruitment; Site monitoring; Data retrieval; Study close-out; Risk mitigation strategies, associated action plan and issue resolution, and contributions to the cross-functional project management plans; Overall responsibility for managing the clinical operations project team and ensuring compliance with ICON SOPs, study contracts, budgets and quality standards.
Syneos Health (Previously INC Research/inVentiv Health)Clinical Lead/Senior Clinical Research Associate II
Mar. 2014 - Mar. 2021Ortigas, Philippines
Site Management: Multicenter, International and local clinical trials, phase II, III, and IV
Experience in conducting pre-study, initation, interim and close out, good knowledge of ICH-GCP CRA Management: Observational and mentoring of new company/junior CRAs, feedback for annual appraisal assessments Project Management: Oversight of APAC and European CRA team; focus on metrics, budget and time usage and allocations, reporting to project leadership, trip report review, forecasting, audit support and CAPA management, local and virtual CRA meetings, support and or creation of plans and documents needed for operational conduct of clinical trials, collaboration with various departments (Site ID and Site Start-up, Data Management, Medical Monitor, Statistics, Pharmacovigilance, etc.) for the successful delivery execution of the project. Therapeutic Area of Experience:
Autoimmunity and Inflammatory: Knee and Hip Osteoarthritis, Rheumatoid Arthritis
CNS Neurology: Parkinson's Disease
CNS Psychiatry: Major Depression, Schizophrenia
Cardiovascular and Metabolic: Pulmonary Hypertension (Pediatric and Adults)
Dermatology: Psoriasis, Atopic Dermatitis
Endocrinology: Type 2 Diabetes Mellitus
Infectious Disease: Tuberculosis Infection (Multi-Drug Resistant), Complicated Urinary Tract Infection, Gram Negative Infections, HAP/VAP/HCABP
Oncology: Cancer, Breast, Cancer, Lung Non-Small Cell, Cancer, Lung HCC
Vaccines: Gynecological Cancer, Diphtheria/Tetanus/Pertussis, 5 in 1, Inactivated Poliovirus, Pneumococcal Conjugate Vaccine, Respiratory Syncytial Virus (pediatric and maternal)
Nutrition/Metabolism: Infants Nutrition
inVentiv Health ClinicalManager, Clinical Research
Dec. 2012 - Mar. 2014Region IVA - Calabarzon, Philippines- Hiring and performance review of direct reports
- Work prioritization of direct reports e.g. scheduling of monitoring visits, trial resource allocation
- Review billability and planning to ensure that resource allocation is optimal
- Ensure that CRAs review new SOPs & Policies prior to their effective date
- Ensure that CRAs complete accurate timesheet by the close of business day every Friday
- Review and approval of expense reports and vacation leave
- Complete a Site Visit Evaluation Form
- Ensure that CRA understands and demonstrates compliance of SOPs & Policies through his/her work.
- Review training needs and arrange for training as required
- Staff retention and motivation
- Deliver trial quality as evidenced by number of protocol deviations, audit findings, IPRF documents
- Ensure that project timelines are adhered
- Provide Project Team Meeting Minutes within 2 business days of the meeting, or per agreed upon timelines.
- Provide the Project Manager or Client with complete and accurate reports on agreed upon frequency.
- Manage tasks/processes as agreed upon with the client
PharmaNet/i3 Strategic ResourcingSenior Clinical Research Associate
Mar. 2007 - Dec. 2012· Assist in managing large scale clinical trial projects or function as project manager for small scale projects, ensuring on-time, on-budget performance
· Monitor (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance according to PharmaNet SOPs and/or client guidelines
· Recruit investigators
· Negotiate study budgets with investigators
· Obtain, review, and process regulatory and administrative documents from investigator sites
· Review and develop protocols
· Review and develop CRFs
· Coordinate and present at Investigators' Meetings
· Participate in proposal meetings with potential clients
· Prepare and review Serious Adverse Event (SAE) reports
· Prepare project management reports for clients, project personnel, and PharmaNet management
· Resolve issues, questions, and requests for additional study supplies
· Review and approve monitoring trip reports
· Review and verify completed CRFs
· Review clinical data in-house
· Resolve queries of CRF data with study site personnel
· Review Tables and Listings generated from study data
MSDClinical Research Associate
Jun. 2003 - Mar. 2007· Train and mentor CRAs on monitoring, internal procedures, and query resolution
· Submit essential/required documents to a central IRB or a country's central Ethics Committee, and, if necessary based on local requirements, the Competent Authority
· Assist in managing large scale clinical trial projects or function as project manager for small scale projects, ensuring on-time, on-budget performance
· Monitor (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance according to PharmaNet SOPs and/or client guidelines
· Recruit investigators
· Negotiate study budgets with investigators
· Obtain, review, and process regulatory and administrative documents from investigator sites
· Review and develop protocols
· Review and develop CRFs
· Coordinate and present at Investigators' Meetings
· Participate in proposal meetings with potential clients
· Prepare and review Serious Adverse Event (SAE) reports
· Prepare project management reports for clients, project personnel, and PharmaNet management
· Resolve issues, questions, and requests for additional study supplies
· Review and approve monitoring trip reports
· Review and verify completed CRFs
· Review clinical data in-house
· Resolve queries of CRF data with study site personnel
· Review Tables and Listings generated from study data
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