BHABES LOUISE SANTOS
Baliwag
Summary
Experienced leader with a strong background in team guidance, project management, and strategic objective achievement. Skilled in developing efficient processes, maintaining high standards, and aligning efforts with organizational goals. Recognized for collaborative approach and unwavering commitment to excellence.
Overview
11
11
years of professional experience
1
1
Certification
Work History
CLINICAL TRIAL MANAGER II
PRA Health Sciences
02.2023 - Current
- Ensures quality of the clinical monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools
- Interacts with the client and other functional departments related to clinical monitoring and site management activities and deliverables
- Participates in business development proposals, defense meetings and proposal development
- Provides development and delivery of initial and ongoing training to the study team
- Plans and leads regular clinical study team calls to provide status updates, ongoing training and accountability to deliverables
- Evaluates staff's competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs) according to company standards and process
- Adheres to scope and routinely reviews Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Data Visualization dashboards (where available) to oversee site and study team conduct, to ensure timely entry of all operational according to plan, and to oversee site and study team conduct and identify any risks to delivery or quality
- Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct
- Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines
- Understands the monitoring strategy required for the study and where required participates in the development of the study risk assessment plan
- Is accountable for the clinical teams understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans
- Adheres to scope to ensure assigned clinical staff routinely assess site processes, perform review of all Source Documents and medical records, and perform Source Document Verification (SDV) per the CMP/SMP and reviews identified and newly emerging risks
- Develops and executes corrective action plans at site and study level, proportionate to the risks identified
- Utilizes systems and tools to assess Key Risk Indicators (KRIs) and ensures that monitoring visits/calls are occurring in line with CMP/SMP
- Proactively collaborates with the data management functional lead to plan towards data cut and lock deadlines
CLINICAL TRIAL MANAGER I
Syneos Health
11.2020 - Current
- Company Overview: formerly INC Research
- Ensures quality of the clinical monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools
- Interacts with the client and other functional departments related to clinical monitoring and site management activities and deliverables
- Participates in business development proposals, defense meetings and proposal development
- Provides development and delivery of initial and ongoing training to the study team
- Plans and leads regular clinical study team calls to provide status updates, ongoing training and accountability to deliverables
- Evaluates staff's competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs) according to company standards and process
- Adheres to scope and routinely reviews Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Data Visualization dashboards (where available) to oversee site and study team conduct, to ensure timely entry of all operational according to plan, and to oversee site and study team conduct and identify any risks to delivery or quality
- Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct
- Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines
- Understands the monitoring strategy required for the study and where required participates in the development of the study risk assessment plan
- Is accountable for the clinical teams understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans
- Adheres to scope to ensure assigned clinical staff routinely assess site processes, perform review of all Source Documents and medical records, and perform Source Document Verification (SDV) per the CMP/SMP and reviews identified and newly emerging risks
- Develops and executes corrective action plans at site and study level, proportionate to the risks identified
- Utilizes systems and tools to assess Key Risk Indicators (KRIs) and ensures that monitoring visits/calls are occurring in line with CMP/SMP
- Proactively collaborates with the data management functional lead to plan towards data cut and lock deadlines
SENIOR CENTRAL MONITORING ASSOCIATE II
Syneos Health
09.2020 - 10.2020
- Company Overview: formerly INC Research
- Performs remote site qualification, site initiation, interim site monitoring calls, and closeout visits ensuring regulatory, ICH-GCP and protocol compliance
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
- Leads the development of the sections of the Clinical Monitoring Plan (CMP)/Site Monitoring Plan (SMP) and tools required for Remote Aggregated Data Review (RADaR) in line with the WI and RADaR guideline
- Conducts project level review and may conduct site level reviews, if CMAs are not assigned to this activity
- With supervision, develops corrective actions / preventative actions and provides direction to CMAs and on-site CRAs
- Understands project scope, budgets, and timelines for own and others in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
- Acts as primary liaison with project site personnel, in collaboration with the onsite CRA
- Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
- Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable)
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
- Provides direct supervision, training and/or mentorship to more junior-level CMAs
- Performs training and sign off visits for junior CMA staff, as assigned
SENIOR CENTRAL MONITORING ASSOCIATE I
Syneos Health
08.2018 - 08.2020
- Company Overview: formerly INC Research
- Primary contact for project site personnel, in collaboration with the on-site CRA
- Responsible for site management including; performance of remote site qualification, remote site initiation, remote interim site monitoring calls (SMCs), and remote close-out visits ensuring regulatory, ICH-GCP and protocol compliance, and completes required actions as requested by clinical leads
- Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
- Performs site-level Remote Accumulated Data Review (RADaR) utilizing the appropriate tools to identify, respond to and manage issues in line with the associated guidelines
- Monitors site performance metrics and with guidance implements action plans for sites not meeting expectations
CENTRAL MONITORING ASSOCIATE III
Syneos Health
01.2018 - 07.2018
- Company Overview: formerly INC Research
- Responsible for remote monitoring and site management of Phase II-IV clinical research studies, conducting all types of remote monitoring visits, inclusive of monthly site monitoring calls
- Maintaining effective communication with sites, establishing solid relationships with Investigators and all other site staff
- Remotely reviews electronic data completed by sites and assists the site in resolving queries and/or other identified data issues
- Completes and submits visit reports according to SOP/Works Instructions (WI) or Sponsor requirements
- Manages assigned sites via inbound and outbound telephone calls/emails and oversees study site activities to ensure the integrity of clinical data
- Monitors site performance metrics and independently implements the majority of action plans for sites not meeting expectations
- Conduct of Site-Level Remote Accumulated Data Review (RADaR) and corresponding follow-up with Clinical lead, Clinical Research Associate (CRA), and/or site personnel as applicable for assigned studies
CENTRAL MONITORING ASSOCIATE II
Syneos Health
07.2016 - 12.2017
- Company Overview: formerly INC Research
- Primary contact for project site personnel, in collaboration with the on-site CRA
- Responsible for site management including; performance of remote site qualification, remote site initiation, remote interim site monitoring calls (SMCs), and remote close-out visits ensuring regulatory, ICH-GCP and protocol compliance, and completes required actions as requested by clinical leads
- Performs site-level Remote Accumulated Data Review (RADaR) utilizing the appropriate tools to identify, respond to and manage issues in line with the associated guidelines
- Monitors site performance metrics and with guidance implements action plans for sites not meeting expectations
CLINICAL RESEARCH ASSOCIATE I
PAREXEL Clinical Research (Philippines) Ltd. Corp.
02.2015 - 07.2016
- Perform the clinical monitoring aspect of designated projects in accordance with study specific procedures, applicable SOPs, and regulations
- Act as direct contact with assigned clinical sites and use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites
- Responsibilities include, but are not limited to, applying expertise and independent judgment to independently verifying patient safety and patient rights, performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, and data collection), collecting regulatory documentation (when required), ensuring timely and high quality data, and performing monitoring of investigational sites in accordance with ICH GCP guidelines
CLINICAL RESEARCH ASSOCIATE I
Covance Asia Pacific Inc.
06.2014 - 12.2014
- Company Overview: Philippine Branch
- Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
- Responsible for all aspects of site management as prescribed in the project plans
- Recruitment of potential investigators, submissions preparation, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
- Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
Education
Bachelor of Science - Pharmacy
University of Santo Tomas
Manila, España01.2013
High School - undefined
Holy Child Catholic School
Manila, Tondo01.2008
Elementary - undefined
Holy Child Catholic School
Manila, Tondo01.2004
Skills
- Study coordination
- Data management
- Site monitoring
- Study documentation
- Fluent in english
- Time management
- Multitasking
- Effective communication
- Active listening
- Detailed documentation
- Training and mentoring
- Document review
Certification
- Certified Central Monitor, International Academy of Clinical Research or IAOCR, 08/30/17
- Clinical Lead Essentials Accredited Training Program, IAOCR 5-star accredited training program, 02/03/20
Licensure Examination
Philippines' Pharmacists Licensure Examination, 06/25/13, 06/26/13, 89.27%
Timeline
CLINICAL TRIAL MANAGER II
PRA Health Sciences
02.2023 - Current
CLINICAL TRIAL MANAGER I
Syneos Health
11.2020 - Current
SENIOR CENTRAL MONITORING ASSOCIATE II
Syneos Health
09.2020 - 10.2020
SENIOR CENTRAL MONITORING ASSOCIATE I
Syneos Health
08.2018 - 08.2020
CENTRAL MONITORING ASSOCIATE III
Syneos Health
01.2018 - 07.2018
CENTRAL MONITORING ASSOCIATE II
Syneos Health
07.2016 - 12.2017
CLINICAL RESEARCH ASSOCIATE I
PAREXEL Clinical Research (Philippines) Ltd. Corp.
02.2015 - 07.2016
CLINICAL RESEARCH ASSOCIATE I
Covance Asia Pacific Inc.
06.2014 - 12.2014
High School - undefined
Holy Child Catholic School
Elementary - undefined
Holy Child Catholic School
Bachelor of Science - Pharmacy
University of Santo Tomas
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