Performance driven professional with 8 years experience in clinical research.
Played a key role in clinical research that concluded in FDA submission and approval.
ICON Clinical Research, Pte. Ltd.January 2013 to April 2014Clinical Research Physician Singapore
Offer hands-on experience and leadership as a clinical and pharmacovigilance expert ensuring scientific integrity and data quality.
Build successful partnerships critical to project and program success.
Deftly call on medical background and years of clinical trials support and oversight and medical literature review to present highly complex data to audience of varied size and levels of understanding.
Adept at training safety team and other key personnel to meet clinical trial requirements.
Expertise includes quality assurance, individual case safety reports.
Ongoing safety review of individual patient laboratory reports generated by central laboratories.
Review of listing of safety data.
The expert medical resource for the trial team as regards study protocol issues.
Worked with Feasibility, Proposal Development and Business Development winning several multi-million global projects.
Performs all reviews and procedures required for database lock.
Ensured conduct of trial activities according to protocol, GCP, FDA and company SOPs through thorough understanding of regulations and standard operating procedures.
Identified adverse events requiring close follow up by thorough review of report.
Improved risk mitigation by responding to site queries in a timely manner and prompt communication of safety issues with concerned members of the team.
ICON Clinical Research, Pte. Ltd.May 2010 to December 2012Manager, Global Feasibility, Site Evaluation and Recruitment Planning Singapore
Collaborate with country directors, project managers, start-up/regulatory team in arriving at appropriate and agreed strategy in recruitment and timelines for proposal development and/or bid defense meetings
Lead the strategic feasibility and recruitment planning discussion at internal proposal/project kick-off meeting
Attend bid defense meetings and present appropriate country and site selection, patient recruitment and retention plans, including the management of the site selection process/recruitment plan implementation as required
Presents capabilities of the team along with protocol-specific recommendations as regards feasibility as well as site and country distribution to clients during bid defense meetings as required
Involvement in the strategic planning as to which countries are best placed to participate in clinical trials.
Conduct appropriate evidence- based feasibility to establish the operational viability of proposed projects through the verification of data relating to previous study performance metrics performed in similar indication/patient population, previous feasibility data, and development of external feasibility studies and consultation with internal and external experts and the investigator community.
Generate budget for paid feasibility proposals Assemble and lead a virtual team during the feasibility and site ID process to collect relevant, high quality data
Train CRAs on project-specific processes or feasibility process in general
Conduct feasibility analysis and prepare detailed client report
Document and track feasibility study results for future use
Develop, initiate, conduct, coordinate and report feasibility studies with support from operation departments
Preparation of internal project information to supported hoc requests for information from clients.
Communicate project status to Senior Feasibility team Build and maintain investigator relations
Mentoring and managing a team of CRAs
Involvement in process improvement within the team.
Quintiles East Asia, Pte. Ltd.March 2008 to May 2010Senior Feasibility Specialist Singapore
Discussion of feasibility issues and seeking clarifications with relevant parties
Providing input to external and internal customers regarding countries' and /or region's capability to conduct clinical trials.
Resource person for relevant information such as disease epidemiology and standards of managing the particular disease medically, patient pool, patient flow to determine which the most appropriate physicians to contact are.
Conduct interviews with KOL's for opportunities either upon sponsor request or to ascertain the veracity of the data gathered in the feasibility exercise if needed.
Contributor to training and development program for clinical coordinators Lead a team of CRAs in the conduct of the feasibility exercise and create a workflow to ensure efficient work processes
Participate in global and regional calls aimed at developing a research strategy
Participate in bid defense meetings
Formulate feasibility questionnaires in accordance with the requirements of the sponsor and the specifications in the protocol
Collate, analyze and generate report from feasibility exercises conducted and comes up with recommended solutions to possible challenges Provide critical information to sponsors on potential regulatory, ethics, and protocol-specific challenges faced in obtaining approvals and suggesting ways to overcome/manage these challenges Training and coaching new feasibility specialists
Interact with Project Management team and the Medical Services team to identify key challenges that may impact on patient recruitment.
Johns Hopkins SingaporeMay 2006 to February 2008Clinical Research Coordinator Singapore
Ensure that all clinical activities are carried out according to the established research protocol and are in compliance with all applicable laws, policies, regulations and procedural requirements
Provide assistance in the review of SAE/UPIRTSO reports for submission to EC/RA as needed, review of laboratory values as supported by the Investigator.
Contribution to the development, review and revision of protocols
Coordination of recruitment, care and treatment of research patients
Pre-screening of patients referred by other physicians prior to actual screening by the investigators
Submission of protocol application for approval to regulatory bodies
Preparation of reports to funding agencies, investigators and regulatory bodies as appropriate
Designing of case report forms in order to capture information required by protocol Drafting of patient informed consent form following GCP, applicable laws and policies as well as regulatory guidelines
Supporting investigator in IND submission to the FDA
Overseeing and planning, scheduling and carrying out of day to day research activities.
Tan Tock Seng HospitalMay 2001 to December 2005Clinical Fellow in Cardiology Singapore
Diagnosis and treatment of coronary artery disease, congestive heart failure, valvular heart diseases in patients both outpatient and in-patient
In-patient assistance to physicians of other disciplines in the diagnosis and management of cardiac problems
Management of critically ill patients in the coronary care and high-dependency units and wards
Risk stratification of cardiac patients for treatment and evaluation prior to non-cardiac surgery
Management of arrhythmias
Coaching and mentoring of medical students and junior doctors
Participation in clinical research as appointed by the Principal Investigator
Presentation in case conferences, journal clubs, etc.
The Doctors' Hospital, IncJanuary 1997 to December 1999Resident, Internal Medicine Bacolod City, Philippines, Negros Occidental
Performed physical examinations on adult patients.
Established medical diagnoses.
Identified acute and chronic illnesses and injuries.
Ordered and evaluated diagnostic studies.
Performed patient assessments in the outpatient and inpatient floors.
Evaluated and treated patients with acute and emergent conditions.
Managed patients with appropriate therapy, medication, education, referral and follow-up.
Determined appropriate imaging and laboratory exams needed.
University of the Philippines1999Bachelor of Science: BiologyIloilo City, Iloilo, Philippines
West Visayas State University1993M.D.: Doctor of MedicineIloilo City, Iloilo, Philippines