Ira Katrina Valerio
Senior Clinical Review Specialist @Ppd
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WORK HISTORY
Senior Clinical Review Specialist @Ppd
Trained and mentored newly hired Clinical Review Specialists Conducts start up tasks (eg. DVM review, Listing Specifications review, etc). • Review patient data in accordance with GCP, SOPs/WPDs, and DVMs. • Liaise with colleagues in other functional groups and management regarding data review activities for allocated studies. • Read and understood project protocols and DVMs. • Review patient data in accordance with the Clinical Listings Review Plan in the DVM. • Identify data issues and work with PPD team to resolve. • Ensure data accuracy according to departmental operating procedures. • Ensure applicable data review activities are completed in a timely manner and meet quality expectations. • Provide support for clinical data review to the CDM project team.
EDUCATION
St. James College of Quezon City
Primary Education, Grade 1-6
St. Paul College of Quezon City
High School, Junior High/Intermediate/Middle School Education and Teaching
Trinity College of Quezon City
Bachelor of Science in Nursing, Registered Nursing/Registered Nurse
United Doctors Medical Center - Southeast Asian College
Bachelor of Science in Nursing, Registered Nursing/Registered Nurse
ABOUT IRA KATRINA VALERIO
Senior Clinical Review Specialist PPD, Part of Thermofisher 1APR2021-Ongoing Clinical Review Specialist- Data Management Division PPD Pharmaceutical Product Development 11MAY2015-31MAR2021 CLINICAL RESEARCH EXPERIENCE: 1.) Clinical Trial Coordinator (Phase 4) under Novartis: National Kidney Transplant Institute: July 2014 to 22 Apr 2015 2.) Clinical Trial Coordinator (Phase 2) under Quintiles: Lung Center of the Philippines: June 2013 to 27 Apr 2015 3.) Clinical Trial Nurse (Phase 3) under Parexel: Lung Center of the Philippines: October 2012-February 2014 Knowledge in Data Management, Drug Safety, Monitoring Experienced External Site Audits for Phases 2 (Study Coordinator) PASSED External Site Audit for Phase 3 (Study Nurse) PASSED Focused Site Visit (Phase 2 as Study Coordinator) by Quality Manager and Director:PASSED MEDICAL EXPERIENCE: Private Duty Nurse at St. Pio Health Care Services: August 2012-September 2012 Company Nurse at Health Delivery System Inc: October 2011-November 2011 Staff Nurse at Wellness Place Care Home: September 2010-November 2010
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