Saranyaporn Phrutisunakon
CTI Clinical Trial & Consulting Services
Singapore
1
Certification
30
years of professional experience
Clinical Pharmacist, Senior Operations and Project Manager with over 20 years of clinical and industry experience in all phases of drug development, including cardiology, oncology, rare diseases, vaccines, bioequivalence and bioavailability.
Work History
Senior Operations Manager
5 Years 6 Months- Provides leadership role in facilitating management of multiple trials (Phases I-IV) across functional areas in Singapore, Thailand, and Asia-Pacific (APAC) region including Australia and China.
- Serves Regional Project Manager and global lead role to manage projects in multiple countries across APAC region including Singapore, Australia, Taiwan and China.
- Managed day-to-day operations of CTI Singapore office, ensuring efficient workflows and effective resource allocation.
- Ensures all assigned staff deliver their project on time, on budget, and with an acceptable level of quality.
- Works with assigned study team and functional leadership to assure client expectations are met or exceeded.
- Synthesizes and analyzes project information and reports outcomes of that analysis to CTI Senior Management and clients.
- Serves as high-level external operational contact at project level and works with management team to develop process improvements across clinical group and across all clinical studies.
- Facilitates management of multiple projects from planning-budgeting-analysis phase for delivery to client.
- Ensures assigned study team coordinates project organization and implements management activities between all functional areas and the client.
- Serves as primary senior interface on project(s) with senior-level associates at CTI and Sponsor.
- Oversees preparation of Project Plan and project timelines, and monitors against project progress; ensures project activities are in compliance with the Plan.
- Suggests and implements alternative solutions to problems with study timelines, schedules, resources, budgets, etc; takes corrective action where necessary.
- Assesses resource needs with functional area managers and establishes appropriate Project Team in conjunction with study team; monitors ongoing resource needs to projects.
- Collaborated with Clinical Project Manager to facilitate staff training sessions on project-related topics.
- Oversees management of budget (hours) by CPM, who evaluates and manages project budget against project milestones; ensures CPM takes corrective measures where necessary to keep project in line with budget expectations.
- Ensures CPM assesses scope of work (SOW) against client contractual agreements and assists in change-in-scope (CIS) orders; provides ultimate sign-off of CIS.
- Conducted high-level analysis of project progress against contractual milestones and sponsor expectations, ensuring timely corrective actions by CPM.
- Reports study progress, issues, and SOW considerations to Senior Management.
- Provides input for Business Development (BD) proposals, assists in project budget preparation / review and represents study management services to BD client presentations; participates in business recruitment and marketing activities; seeks BD opportunities when appropriate and communicates these opportunities to those responsible.
- Supervised and mentored staff, fostering independence and skill development to enhance team capabilities.
- Reviews and assesses internal / external generalized quality control (QC) reports for assigned projects and assures corrective action as necessary by Study Management Team.
- Provides suggestions and works on implementation of process improvement initiatives across clinical programs.
Associate Clinical Project Manager
1 Year- Monitored projects on regular basis, evaluating progress and quality, and managing issue resolution process to ensure corrective actions were taken.
- Conducted project meetings to clarify roles and expectations for CRAs, CPAs, and other team members, ensuring effective access to necessary tools and training.
- Monitored projects regularly, evaluated progress and quality, and managed issue resolution process to implement corrective actions promptly.
- Worked with CPM and management team to report analyzed data and communicated results.
- Developed additional tools and refined processes to help all projects run effectively; e.g., Study trackers, essential documents tracker.
- Developed tools and refined processes, including study trackers and essential documents tracker, to enhance project efficiency and organization.
- Scheduled and organized project activities to ensure timely progress.
- Study / site budgets were set up, estimated, and monitored to ensure budgets were correct estimation and paid.
- Analyzed and discussed potential risk or benefit involved in using specified technology solution to address project requirements.
- Developed and implemented project plans, aligning resources with study objectives.
- Led cross-functional teams to ensure timely execution of clinical trials.
- Managed project budgets and timelines, ensuring compliance with regulatory standards.
- Facilitated communication between stakeholders, enhancing collaboration and problem-solving.
- Mentored junior staff on best practices in clinical trial management.
- Analyzed project performance data to identify areas for improvement and efficiency gains.
- Established risk management strategies to mitigate potential project challenges.
- Fostered relationships with external partners to support strategic project goals.
- Implemented innovative strategies to improve patient recruitment and retention rates in clinical studies.
- Improved clinical trial efficiency by streamlining project management processes and implementing best practices.
- Optimized resource allocation across multiple concurrent projects by utilizing advanced scheduling tools.
- Oversaw contract negotiation and vendor selection for clinical projects, securing cost-effective solutions without compromising quality or timelines.
- Facilitated strong relationships between study sites, sponsors, and internal teams through regular updates and effective communication strategies.
- Coordinated site visits and audits for ongoing quality assurance during all phases of the clinical trial process.
- Reduced project timelines for successful clinical trials by effectively managing resources and maintaining clear communication with stakeholders.
- Streamlined data management processes for efficient analysis and reporting of results from clinical studies.
- Enhanced patient safety during clinical trials with rigorous monitoring and strict adherence to protocols.
- Collaborated closely with medical experts, investigators, and external partners to ensure accurate data collection in line with research objectives.
- Managed cross-functional teams, resulting in seamless collaboration and increased productivity in clinical projects.
- Conducted thorough risk assessments for each project, proactively mitigating potential issues before they escalated.
- Championed continuous improvement initiatives resulting in increased efficiency and cost savings for clinical projects.
- Developed strong partnerships with key stakeholders to facilitate smooth handovers during project transitions.
- Achieved timely completion of all assigned clinical projects while remaining within budget constraints.
- Established a culture of excellence within the team, leading by example and fostering an environment where high-quality work was consistently delivered.
- Developed comprehensive training programs for new hires, ensuring a high level of competency within the team.
- Mentored junior team members through skill development workshops and one-on-one coaching sessions to enhance their abilities in managing complex projects successfully.
- Communicated effectively with staff members, physicians, and patients, employing active listening and interpersonal skills.
- Delegated tasks to staff members, monitored completion of all duties and provided support to enhance performance.
- Regularly evaluated employee performance and provided feedback.
- Promoted high morale and staff retention through dynamic communication, prompt problem resolution, proactive supervisory practices and facilitation of positive work environment.
- Identified opportunities to improve clinical practices, devised strategies and implemented plans to increase patient care standards and enhance operational procedures.
- Oversaw overall operation of nursing services and patient care.
- Delivered effective onboarding and training to new and existing employees and cross-trained staff members in other job roles to maximize coverage.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Senior Clinical Research Associate / Lead Clinical Research Associate
2 Years- Participated in the Investigator recruitment process; performed site evaluation visits of potential Investigators; evaluated capability of site(s) to manage and conduct clinical study.
- Coordinated activities with start-up team and site(s) to ensure seamless preparation for study initiation.
- Obtained regulatory documentation for successful implementation, monitoring, evaluation of clinical trials.
- Worked with start-up team and site staff to obtain regulatory (Institutional Review Board [IRB] / Independent EC [IEC]) approval of study specific documents.
- Performed study initiation activities, reviewed protocol with site personnel for regulatory issues, study procedures, and provided training on completion of electronic case report form (eCRF); monitored ongoing activities and study close-out activities.
- Trained site staff on the electronic data capture (EDC) system and verified site computer system.
- Assured adherence to GCPs, Investigator integrity, and compliance with all study procedures through on-site monitoring visits (MVs); performed validation of source documentation.
- Prepared MV reports (MVRs) and follow-up letters per timelines defined.
- Documented accountability, stability, and storage conditions of clinical trial materials; performed investigational product (IP) inventory; ensured return of unused materials to designated location or verified destruction.
- Reviewed quality and integrity of clinical data through (1) in-house review of eCRF data and (2) on-site source document verification (SDV); worked with sites to resolve data queries.
- Reviewed draft study documents, including study manuals, and prepared study-related documents and templates.
- Acted as primary point of contact between Sponsor and Investigator, managing all correspondence and facilitating timely clinical data transmission with study site.
- Assisted CTM and/or CPM in project budget review, monitored costs, potential overruns, and proposed / implemented cost effective solutions.
- Assisted study management in identifying and generating CISs.
- Performed study close-out visits (COVs) per study specific Clinical Monitoring Plan including final IP reconciliation and disposition, site study file reconciliation, data query resolution through to database lock (DBL) and resolution of outstanding action items.
- Ensured all study deliverables were completed as per study timelines.
- Served as mentor for junior CRAs and those new to the company and/or study.
- Participated in performance appraisal program by providing timely and accurate feedback regarding performance of perspective CRA.
- Reviewed and approved CRA travel expenses and time sheets.
- Executed various assigned tasks to support team operations., as requested.
- Led clinical trial monitoring activities, ensuring compliance with regulatory and protocol requirements.
- Mentored junior staff on best practices in clinical research methodologies and regulatory guidelines.
- Collaborated with cross-functional teams to optimize study design and execution for improved outcomes.
- Conducted site evaluations and feasibility assessments to identify potential challenges early in the process.
- Streamlined data collection processes, enhancing accuracy and reducing turnaround time for study results.
- Presented findings to stakeholders, facilitating informed decision-making throughout the project lifecycle.
- Drove continuous improvement initiatives, increasing operational efficiency within clinical research projects.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Achieved project objectives by troubleshooting experiments and testing practical and creative solutions.
- Facilitated seamless transitions between study phases through proactive planning, coordination, and communication with internal stakeholders.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
Senior Clinical Research Associate
1 Year- Performed site selection, initiated and monitored Investigator sites, and closed out sites following Parexel international SOP and regulations.
- Facilitated study preparation and submission processes to IRB/IEC in Thailand and Singapore, and to HA in Thailand.
- Provided guidance and support to junior clinical research associates to enhance their skills and knowledge.
Senior Clinical Research Associate
2 Years- Conducted site selection, initiation, monitoring, and close-out of investigator sites in compliance with Parexel SOP, regulations, and ICH/GCP guidelines.
- Supported study preparation and submission to IRB/IEC in Thailand and Singapore, facilitating regulatory approvals.
- Provided guidance to junior CRAs in clinical trial processes.
- Led clinical trial management, ensuring compliance with regulatory standards and protocols.
- Mentored junior associates, enhancing team performance and promoting best practices in research methodologies.
- Conducted site visits to assess trial progress, identify issues, and provide strategic solutions for resolution.
- Reviewed study documentation for accuracy, ensuring adherence to Good Clinical Practice (GCP) guidelines.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Clinical Research Associate I/II
1 Year- Performed clinical monitoring activities from site initiation to close-out according to ICON’s SOPs and local regulations.
- Executed study start-up preparation, including IRB/IEC submissions and coordination with Thailand Food and Drug Administration (TFDA).
- Collaborated with local CRA in Vietnam (4 sites) for co-monitoring to address backlogs and uphold study file quality as requested by Sponsor.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Clinical Research Associate
1 Year- Monitored vaccine trial from study start-up to close-out according to Sanofi Pasteur’s SOPs and local regulations.
- Set up site for TFDA inspection by organizing necessary documentation and ensuring compliance with regulations.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
Clinical Research and Safety Manager
3 Years- Led phase IV study to ensure compliance and safety standards.
- Established communication channel for safety reporting between marketing team and stakeholders.
- Developed local SOPs for pharmacovigilance to streamline safety reporting processes.
- Performed product training to sales representatives and pharmacy students.
Hospital Pharmacist
6 Years- Drug Counseling in asthma, HIV, diabetes, hypertension (HTN), and other drug non-compliance.
- Provided safe and effective medication delivery to support patient health.
- Provided drug counseling for asthma, HIV, diabetes, hypertension, and other non-compliance issues, improving patient understanding and adherence.
- Participated in adverse drug reaction monitoring team, identifying and reporting reactions to enhance patient safety.
- Delivered unit dose medications to ensure timely access for patients.
- Trained pharmacy students and health care practitioners in pharmaceutical care tasks, fostering knowledge and skills for improved patient outcomes.
Education
Master of Science - Clinical Pharmacy
Bachelor’s Degree - Pharmaceutical Science
Skills
Project management expertise
Regional project management
Clinical trial systems
APAC monitoring
Regulatory submissions expertise
Regulatory compliance
Contract negotiation
Feasibility assessments
Regulatory oversight
Vendor management
EDC
CTMS
eTMF experienced
Forecasting
Facility management
Budget administration
Workforce planning
Operational excellence
Operations management
Affiliations
Member, Thai Pharmacy Association
Certification
Thai Pharmacist License, a11766 (1997 – Present)
Languages
Thai (mother tongue), English (fluent: speaking, reading; business level: writing), Japanese (basic)
CTI Clinical Trial Experience
- Phase I relative bioavailability single-site study (CPM: Australia)
- Phase III multicenter, randomized, double-blinded, placebo-controlled study to assess efficacy and safety of xxx in patients with pulmonary hypertension (PH) with interstitial lung disease (ILD); WHO group 3 (Regional CPM : Australia, Taiwan, Singapore, and China)
- Phase III open-label study of long-term neurocognitive outcomes in children with phenylketonuria (PKU) (CPM: Australia)
- Phase III randomized, placebo-controlled study to assess efficacy and safety of xxx in addition to standard of care (SOC) in classical homocystinuria (HCU) due to cystathionine beta synthase deficiency (CPM: Australia, and New Zealand)
- An Open-Label, Phase 3 Long-Term Extension (LTE) Study to assess the safety, tolerability and efficacy of Treatment with Classical Homocystinuria (HCU) due to cystathionine beta synthase deficiency (CPM: Australia)
- Phase I dose-escalation study assessing safety and pharmacokinetics (PK) of xxx in healthy volunteers (HVs) (unblinded CPM: Australia)
- Phase I first-on-human (FIH), multiple-part, single-ascending and multiple-dose study of xxx in healthy participants and in participants with PKU (unblinded CPM 2 countries: Australia, US)
- Frameless neuronavigation with real-time tracking for ventricular catheter placement (medical device trial, 2 sites Singapore)
- Phase I/II randomized, observer-blind study of safety, reactogenicity, and immunogenicity of 3 SARS-CoV-2 RNA Vaccine Candidates (novel COVID-19 vaccine, in 3 countries: Singapore, US, South Africa)
- Phase I/II, randomized, double-blinded, placebo controlled, ascending-dose study to assess safety, tolerability, and immunogenicity of xxx in healthy adult subjects (novel COVID-19 vaccine, 1 site Singapore)
- Phase IIa, open-label extension (OLE) study to assess safety and long-term immunogenicity of xxx (novel COVID-19 vaccine, 1 site Singapore)
- Phase IIb/III, prospective, randomized, double-blind, sham-controlled trial of xxx in subjects with neurologic manifestations of Niemann-pick type C1 (NPC1) disease (1 site Singapore)
- Phase II, multicenter, prospective, randomized, open-label study of efficacy and safety of once-a-day xxx tablets compared to twice-a-day xxx capsules in de novo liver transplant recipients (Feasibility)
- Phase II, prospective, randomized, open-label, safety, and efficacy of xxx in subjects with type 2 diabetes mellitus (T2DM) and chronic kidney disease (Feasibility)
- Phase IIa, double-blind, placebo-controlled study to evaluate pharmacodynamics (PD), PK, and safety of xxx administered orally in subjects with idiopathic pulmonary fibrosis (Feasibility)
- Phase II, randomized, open-label, controlled study to evaluate efficacy and safety of xxx in subjects with CSG or HC-MP GN
- Phase II, open-label, single-arm study to evaluate safety, tolerability, and biologic activity of xxx in pediatric patients with paroxysmal nocturnal hemoglobinuria (Feasibility)
Other Clinical Trial Experience
- Phase II/III, multicenter randomized double-blinded, placebo-controlled, repeat-dose study to evaluate efficacy, safety, PD, and PK of xxx in patients with acid sphingomyelinase deficiency (7 sites across USA, the Netherlands, United Kingdom [UK])
- Prospective surveillance of hospitalized dengue patients in Asia – preparation phase of vaccine effectiveness study (3 sites Malaysia)
- Randomized, double-blind, triple-dummy trial to compare efficacy of xxx with unfractionated xxx + xxx in patients with unstable angina / non-ST segment elevation myocardial infarction scheduled to undergo an early invasive strategy (10 sites Thailand)
- Multicenter, double-blind, parallel-group, placebo-controlled study of efficacy and safety of xxx in patients with relapsing multiple sclerosis (2 sites Thailand)
- Multinational, randomized, double-blind study of xxx vs placebo with Irinotecan / 5-FU combination (FOLFIRI) in patients with metastatic colorectal cancer (MCRC) after failure of an oxaliplatin based regimen (3 sites in Singapore)
- Randomized, double-blind, placebo-controlled, parallel-group trial for assessing clinical benefit of xxx BID on top of standard therapy in patients with permanent atrial fibrillation (AFIB) and additional risk factors (4 sites Thailand)
- Randomized, double-blind, placebo-controlled, parallel-group study to evaluate effect of xxx on occurrence of cardiovascular events in patients who have recently experienced an acute coronary syndrome (3 sites Singapore, 2 sites Malaysia)
- Randomized, double-blind, parallel-group study to evaluate efficacy and safety of xxx vs xxx in Asia in high cardiovascular risk patients with hypercholesterolemia not adequately controlled with their statin therapy (4 sites Thailand)
- Randomized, double-blind, multicenter placebo-controlled study assessing clinical benefits of xxx added to conventional disease modifying anti-rheumatoid drugs (DMARDs) in Asian patients with moderately to severely active rheumatoid arthritis (RA) who are inadequate responders to conventional DMARD therapy (3 sites Thailand)
- Disease registry for Fabry, Gaucher, Mucopolysaccharidosis (MPS) I and Pompe (1 site Malaysia, 1 site Singapore)
- Multicenter, uncontrolled extension study evaluating efficacy and safety of xxx in patients with active RA (2 sites Thailand, 2 sites Taiwan, 2 sites Malaysia, and 2 sites Philippines)
- Cross-sectional study of renal function in treatment-naïve, young male patients with Fabry disease (1 site Taiwan)
- Multinational, cross-sectional, observational study to describe glycemic control and quality of life for T1DM adult patients (3 sites Taiwan)
- Retrospective analysis to review efficacy and safety of xxx in the immunosuppressive therapy for treating aplastic anemia (1 site Singapore, 1 site Malaysia)
- Bioequivalence studies in HVs for 7 molecules (1 molecules / 1 BE center India)
Therapeutic Experience
- Autoimmune Disease
- Rheumatoid Arthritis
- Cardiology
- Central Nervous System
- Huntington Disease
- Niemann-Pick
- Congenital / Genetic Disorders / Rare Disease / Orphan Drug
- Mucopolysaccharidosis
- Pompe Disease
- Homocystinuria
- Phenylketonuria
- Device
- Endocrinology / Metabolism
- Diabetes
- Healthy
- Drug-to-Drug Interaction
- Single- and Multiple-Ascending Dose
- Food Drug Interaction
- Hepatology
- Alcoholic Hepatitis
- Cirrhosis
- Hepatic Impairment
- Non-Alcoholic Steatohepatitis
- Infectious Disease
- COVID-19
- Cytomegalovirus
- Hepatitis C
- Influenzas
- Immune System Disorders
- Immunosuppression
- Musculoskeletal
- Osteoarthritis
- Nephrology
- Acute Kidney Injury
- Chronic Kidney Disease
- Oncology
- Blood
- Leukemia
- Lymphomas
- Hodgkin’s Lymphoma
- Non-Hodgkin’s Lymphoma
- Multiple Myeloma
- Gastrointestinal / Genitourinary
- Lung
- Pediatric
- Vaccines
- Pulmonology
- Asthma
- Sleep Apnea
- Pulmonary Hypertension WHO class 3
- Surgical
- Heart
- Vaccine
- Japanese Encephalitis
- Dengue Vaccine
- Flu
- H5N1
- Bioequivalent Trials
- Bioavailability Study
Publications and Presentations
A comparison of the efficacy and tolerability of lipid lowering between atorvastatin 10 mg daily and 10 mg every day in patients with hypercholesterolemia, ASEAN Heart Journal, 2003;10(1):1-7.
Awards / Accomplishments
December 2021: CTI Spotlight, December 2022: 5-year Anniversary with CTI
Timeline
Senior Operations Manager
CTI Clinical Trial & Consulting Services
01.2021 - CurrentRead More
Associate Clinical Project Manager
IQVIA
01.2016 - 01.2017Read More
Senior Clinical Research Associate / Lead Clinical Research Associate
IQVIA
01.2013 - 01.2015Read More
Senior Clinical Research Associate
Parexel International Pte, Ltd.
01.2012 - 01.2013Read More
Senior Clinical Research Associate
Parexel International Pte, Ltd.
01.2010 - 01.2012Read More
Clinical Research Associate I/II
ICON Clinical Research Pte, Ltd.
01.2009 - 01.2010Read More
Clinical Research Associate
Sanofi Pasteur Pte, Ltd.
01.2008 - 01.2009Read More
Clinical Research and Safety Manager
Takeda Pte, Ltd.
01.2004 - 01.2007Read More
Hospital Pharmacist
Chumphon Hospital
01.1997 - 01.2003Read More
Chulalongkorn University
Master of Science from Clinical Pharmacy
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Prince of Songkhla University
Bachelor’s Degree from Pharmaceutical Science
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