Clinical Trial Management System
MARK JAY ARMADA, RPh
Quality Specialist / Senior CRA 3 / Lead CRA / Licensed Pharmacist
Quezon City,Metro Manila
Summary
Accomplished Senior Clinical Research Associate with 11 years of Site Management experience for several global clinical trials (Phase 2 to Phase 4) including 1.5 years in Quality Management, APAC Feasibility Lead for rare disease and as Site Start Up Specialist for COVID-19 vaccine study. Mentored and supported less experienced Clinical Research Associate. Managed studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of ICH-GCP, regulatory requirements and quality standards.
Overview
2
2
Languages
9
9
Certifications
4
4
years of post-secondary education
12
12
years of professional experience
Work History
Quality Specialist
IQVIA
Metro Manila, Philippines
08.2019 - 01.2021
- Provided Quality Management support to the CRA and site for the successful conduct of an EMA Site Inspection (Oncology, 2019) including timely closure of Corrective and Preventive Action Plan
- Maintained Quality Key Performance Indicators in control (green metrics) and monitored execution of Country Quality Plan regularly; discussed gaps and action plan with the local management
- Managed clinical operations risks and quality issues through data review and quality control, provided support in risk mitigation, in planning corrective/preventive actions and improvement
- Worked closely with Quality Assurance (assigned internal Quality Auditor) in case of Quality Issues and in management of audit reports
- Mentored and Conducted Lessons Learned training sessions for the local team based on gaps, quality issues, common audit/inspection findings
- Provided consultation, advice and support to operational teams within the assigned business line, including Clinical Research Associates, Line/Site Network Managers, Resource Managers and other key stakeholders on all aspects of GCP compliance, quality control, risk management, and corrective/preventive actions
- Provided regular updates to team leadership (Head of Site Management for Southeast Asia and Head of Quality Management for APAC) on quality metrics and process gap improvements
- Contributed to the development and implementation of a Regional/Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program and monitored the implementation and delivery
Senior Clinical Research Associate 3
IQVIA
Metro Manila, Philippines
07.2019 - 01.2021
- Monitored and supported successful conduct of Sponsor Site Audit(Lupus, 2019) which resulted to zero major or critical findings including timely closure of Corrective and Preventive Action Plan
- Supervised less experienced CRAs especially those who are new to therapeutic indication by conducting weekly catch up, co-monitoring, training and consultation to ensure that project knowledge is consistent within the team and to facilitate accomplishment of study milestones
- Acted as mentor and local Lead CRA for Lupus and Vaccine studies, communicated and coordinated country-level progress and status to the Project Manager and assisted the Project Team on the delivery of study milestones for Philippines from recruitment to database lock
- Delivered key study milestones such as recruitment and database cleaning ahead of schedule (averaging 2 weeks to 1 month ahead of target completion)
- Conducted Accompanied Site Visits and skill evaluation to both Junior and Senior CRAs to ensure that monitoring skills are achieved, and their gaps are addressed
- Assisted the Quality Manager in performing Focused Site Visit (site quality visit and assessment) and Country Risk Assessment
- Received recognition for Quality, Project Delivery and Leadership
- Exceeded annual performance goals on productivity and quality
- Drove company's revenue by adhering to the number of visits and Days On Site (DOS) according to Clinical Operations Plan and by performing onsite visits equivalent to an average of 8-10 days per month
- Reduced time in drafting reports by making master visit report per study based on visit report annotation and customized it per site and visit
- Prepared and submitted visit reports within 3 days of the site visit without overdue reports
- Same responsibilities as enumerated for Junior CRA role
Regulatory and Start up Specialist
IQVIA
Metro Manila, Philippines
09.2020 - 01.2021
- Special Assignment / Interim Role
- Completed start up and site activation activities for a COVID-19 vaccine study such as Ethics Committee and Regulatory submissions/approvals, budget/contract discussions and distribution of completed documents to 10 investigative sites within 90 days from site selection
- Prepared site regulatory documents and reviewed them for completeness and accuracy
- Reviewed, tracked and followed up the progress, the approval and execution of documents, regulatory, ethics committee (EC), Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines and implemented contingency plan as needed
- Served as Single Point of Contact between sites, sponsor, Site Activation Manager, Project Management team, and other departments as necessary
- Ensured adherence to standard operating procedures (SOP), Work Instructions (WIs), quality of designated deliverables and project timelines
- Ensured accurate completion and maintenance of internal systems, databases and tracking tools with project specific information
- Reviewed and provided feedback to management on site performance metrics
- Informed team members of completion of regulatory and contractual documents for individual sites
- Provided local expertise to Site Activation Manager and project team during initial and on-going project timeline planning
- Performed quality control of documents provided by sites
Regional Feasibility Lead
IQVIA
Metro Manila, Philippines
06.2020 - 07.2020
- Special Assignment / Interim Role
- Performed, managed, and led activities associated with feasibility for a rare disease (Post-Herpetic Neuralgia) across APAC region through therapeutic area research using numerous internal & external databases, scientific literature, the Internet, and seeking expert medical knowledge to provide background information and conclusion
- Performed country outreach, interpreted feasibility results and provided feedback, recommendations and reporting to determine IQVIA commitments for future studies in terms of recruitment rate, timelines and screen failure rates.
- Developed feasibility analysis systems and data collection tools in Excel, PowerPoint or other Business Intelligence platforms to support the collection of country feasibility metrics.
Senior Clinical Research Associate 2
IQVIA
Metro Manila, Philippines
04.2015 - 06.2019
- Monitored and supported successful conduct of Sponsor Site Audit (Lupus, 2018) and US FDA Site Inspection (Oncology, 2018) which resulted to zero major or critical findings including timely closure of Corrective and Preventive Action Plan
- Addressed recruitment gaps for lupus studies, exceeded country target by 20% which positively affected global recruitment target
- Supervised less experienced CRAs especially those who are new to therapeutic indication by conducting weekly catch up, co-monitoring, training and consultation to ensure that project knowledge is consistent within the team and to facilitate accomplishment of study milestones
- Acted as mentor and local Lead CRA for Lupus and Vaccine studies, communicated and coordinated country-level progress and status to the Project Manager and assisted the Project Team on the delivery of study milestones for Philippines from recruitment to database lock
- Delivered key study milestones such as recruitment and database cleaning ahead of schedule (averaging 2 weeks to 1 month ahead of target completion)
- Conducted Accompanied Site Visits and skill evaluation to both Junior and Senior CRAs to ensure that monitoring skills are achieved, and their gaps are addressed
- Assisted the Quality Manager in performing Focused Site Visit (site quality visit and assessment) and Country Risk Assessment
- Received recognition for Quality, Project Delivery and Leadership
- Exceeded annual performance goals on productivity and quality
- Drove company's revenue by adhering to the number of visits and Days On Site (DOS) according to Clinical Operations Plan and by performing onsite visits equivalent to an average of 8-10 days per month
- Reduced time in drafting reports by making master visit report per study based on visit report annotation and customized it per site and visit
- Prepared and submitted visit reports within 3 days of the site visit without overdue reports
- Same responsibilities as enumerated for Junior CRA role
Senior Clinical Research Associate 1
IQVIA
Metro Manila, Philippines
10.2013 - 03.2015
- Supervised less experienced CRAs especially those who are new to therapeutic indication by conducting weekly catch up, co-monitoring, training and consultation to ensure that project knowledge is consistent within the team and to facilitate accomplishment of study milestones
- Exceeded annual performance goals on productivity and quality
- Drove company's revenue by adhering to the number of visits and Days On Site (DOS) according to Clinical Operations Plan and by performing onsite visits equivalent to an average of 12-15 days per month
- Reduced time in drafting reports by making master visit report per study based on visit report annotation and customized it per site and visit
- Prepared and submitted visit reports within 3 days of the site visit without overdue reports
- Same responsibilities as enumerated for Junior CRA role
Clinical Research Associate 2
IQVIA
Metro Manila, Philippines
10.2012 - 09.2013
- Monitored and supported successful conduct of US FDA Site Inspection (Vaccine, 2012) which was the very first Regulatory Inspection for IQVIA Philippines. No major/critical findings were noted
- Drove company's revenue by adhering to the number of visits and Days On Site (DOS) according to Clinical Operations Plan and by performing onsite visits equivalent to an average of 12-15 Days per month
- Reduced time in drafting reports by making master visit report per study based on visit report annotation and customized it per site and visit
- Prepared and submitted visit reports within 3 days of the site visit without overdue reports
- Performed site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
- Negotiated legal study contracts and financial arrangements with sites within agreed limits including documentation and coordination of timely payments to sites
- Supported the development, adaptation and tracking of project subject recruitment plan on a per site basis
- Conducted site trainings and able to do training materials and presentations
- Provided site management for a variety of protocols, sites and therapeutic areas
- Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations including timely escalation of quality issues
- Managed 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 accurately and timely
- Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Collaborated and liaised with study team members for project execution support as appropriate
Clinical Research Associate 1
IQVIA
Metro Manila, Philippines
08.2010 - 09.2012
- Drove company's revenue by adhering to the number of visits and Days On Site (DOS) according to Clinical Operations Plan and by performing onsite visits equivalent to an average of 12-15 Days per month
- Reduced time in drafting reports by making master visit report per study based on visit report annotation and customized it per site and visit
- Prepared and submitted visit reports within 3 days of the site visit without overdue reports
- Performed site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
- Negotiated legal study contracts and financial arrangements with sites within agreed limits including documentation and coordination of timely payments to sites
- Supported the development, adaptation and tracking of project subject recruitment plan on a per site basis
- Conducted site trainings and able to do training materials and presentations
- Provided site management for a variety of protocols, sites and therapeutic areas
- Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations including timely escalation of quality issues
- Managed 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 accurately and timely
- Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Collaborated and liaised with study team members for project execution support as appropriate
Clinical Research Associate Trainee
IQVIA
Metro Manila, Philippines
02.2010 - 07.2010
- Completed 6-month CRA Core Development Program
- Performed site monitoring in accordance with contracted scope of work and good clinical practice under supervision of Senior CRA and Line Manager
- Provided site management for a variety of protocols, sites and therapeutic areas
Education
Bachelor of Science - Pharmacy
University of Santo Tomas
Philippines 06.2005 - 03.2009
Skills
Trial Management / Site Management
undefinedAdditional Information
- COVID-19 Vaccine / Phase 2,3
- Japanese Encephalitis Vaccine / Phase 3
- Influenza Vaccine / Phase 3
- Systemic Lupus Erythematosus / Phase 2,3,4
- Cutaneous Lupus Erythematosus / Phase 2,3
- Rheumatoid Arthritis / Phase 3
- Relapsing Multiple Sclerosis / Phase 3
- Breast Cancer / Phase 3
- Non-Small Cell Lung Cancer / Phase 2,3
- Schizophrenia / Phase 3
- Chronic Obstructive Pulmonary Disease / Phase 3b
- Type 2 Diabetes Mellitus / Phase 3
Certification
Passed the Philippines Pharmacist Licensure Exam
Accomplishments
- IQVIA Impact Program - Spotlight Award (Quality) - APAC PAIR Recognition, Q3 2019
- IQVIA Impact Program - Ovation Award (Project Delivery) - Lupus Study, 2019
- IQVIA "Because It Matters Program" Shout Out Award (Project Recruitment) - Flu Vaccine Study, 2019
- IQVIA "Because It Matters Program" Shout Out Award (Project Delivery) - Lupus Study, 2019
- IQVIA "Because It Matters Program" Shout Out Award (Project Recruitment) - Lupus Study, 2018
- IQVIA "Because It Matters Program" Bravo Award (Project Recruitment) - Lupus Study, 2018
- IQVIA "Because It Matters Program" Shout Out Award (Exceeded Days On Site target, 100% SVR/FUL Compliance and Management of Action Items), Q2 2018
- IQVIA "Because It Matters Program" Shout Out Award (Exceeded Days On Site target, 100% SVR/FUL Compliance and Management of Action Items), Q1 2018
- IQVIA "Because It Matters Program" Bravo Award (Project Quality - Zero major/critical findings) - Lupus Study, 2018
- Quintiles "Because It Matters Program" Applause Award (Project Delivery and Lead CRA) - Lupus Study, 2018
- Quintiles "Because It Matters Program" Applause Award (Project Delivery) - COPD Study, 2017
- Quintiles Customer ThankQ Award (Teamwork/Database Cleaning) – Lupus Study, 2016
- Quintiles "Because It Matters Program" Applause Award (SVR Compliance), 2016
- Quintiles Achievement Award (Teamwork/Site Visit), 2016
- Quintiles Triumph Award (Leadership/100% SVR Compliance), 2016
- Quintiles Outstanding Engagement Award (Teamwork), 2015
- Quintiles Salute Award (Teamwork/Recruitment) - Lupus Study, 2015
- Quintiles Shout Out Award (Teamwork /Database Cleaning) – Diabetes Study, 2015
- Quintiles ThankQ Award (Teamwork – Investors in People), 2015
- Quintiles Special Achievement Award 2 (Customer Service), 2015
- Quintiles Special Achievement Award 1 (Customer Service) - Lupus Study, 2014
- Quintiles Applause Award (Leadership), 2014
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Software
Infosario
Inform
Medidata RAVE
OC-RDC
Microsoft Office (Word, Excel and PowerPoint)
Quote
All progress takes place outside the comfort zone.
Michael John Bobak
Timeline
Regulatory and Start up Specialist
IQVIA
09.2020 - 01.2021
Regional Feasibility Lead
IQVIA
06.2020 - 07.2020
Fundamental GCP Training Course and Accreditation Exam (English) 4.0
01-2020
Quality Specialist
IQVIA
08.2019 - 01.2021
Senior Clinical Research Associate 3
IQVIA
07.2019 - 01.2021
Expert GCP Accreditation Exam (English) 3.0
01-2018
Barnett Accreditation: Good Clinical Practice for Clinical Trials - Expert
01-2016
Senior Clinical Research Associate 2
IQVIA
04.2015 - 06.2019
Barnett Accreditation: Good Clinical Practice for Clinical Trials - Expert
01-2014
Senior Clinical Research Associate 1
IQVIA
10.2013 - 03.2015
Clinical Research Associate 2
IQVIA
10.2012 - 09.2013
Barnett Accreditation: Expert GCP EXAM for managers and staff interacting with investigational sites
01-2012
ICH GCP and E2A Refresher
01-2011
Barnett Accreditation - Good Clinical Practices for Clinical Trials for Staff Interacting with Investigational Sites
12-2010
Clinical Research Associate 1
IQVIA
08.2010 - 09.2012
Core Clinical Research and GCP/SOP Training
07-2010
Clinical Research Associate Trainee
IQVIA
02.2010 - 07.2010
Passed the Philippines Pharmacist Licensure Exam
07-2009
Bachelor of Science - Pharmacy
University of Santo Tomas
06.2005 - 03.2009
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