Mary Eugenia Alas
Tampa,USA
Summary
Over 16 years of experience working in clinical research with over 8 years of experience as Clinical Research Associate, and 8 years as a Clinical Trial Manager. Functional Lead with responsibility for delivery of all clinical aspects of clinical Trials. Trial management for multi-study, multi-national, multi-center program. Experience handling and supporting clinical trials in the United States, Brazil, Peru, Korea, Singapore, Japan, West and South Africa, Bangladesh, and Thailand. Experience with Protocol Development of draft near final protocols, and final or almost final versions of Protocols, Investigator’s Brochures or current Package Insert; Informed Consent Form Templates; Manual of Procedures and appendices; draft Case Report Forms, and/or Data Collection Forms capturing original data source data; and Study Product Accountability Logs and/or Pharmacy Worksheets/Instructions or forms. Ability to critically analyze documents to identify discrepancies and other impediments to protocol execution; with demonstrated ability to use clear, concise, and plain language to describe findings; and timely communication of potential safety concerns and potential safety risks. Accomplished in driving studies, site management, ensuring consistency with ICH/GCP, applicable regulations, developing Monitoring Plans, study specific templates, implementing strategies for onboarding of international staff, supporting Sponsor and Sites with international regulatory inspections (PMDA and MFDS) and FDA inspections and competent in delivery of unblinded monitoring of investigational product aspects. Successful performer while working under pressure for expedited timelines with proven Sponsor recognition; and continuously meeting timelines, goals, deliverables and expectations.
Overview
26
26
years of professional experience
Work History
Sr. Clinical Trial Manager
ICON Clinical Research
Tampa, USA
04.2021 - Current
Unblinded Clinical Trial Manager
ICON Clinical Research
Tampa, USA
09.2021 - 01.2023
- Responsibilities include Delivery of unblinded monitoring of investigational product aspects
- Serve as the liaison between the Project Manager and two unblinded Clinical Research Associates (CRAs) assigned to given sites for the management of all unblinded aspects of investigational product monitoring and, ensuring consistency with ICH/GCP and applicable ICON Standard Operating procedures (SOPs), applicable regulations
- Responsible for planning, scheduling and implementing unblinded monitoring in line with contract and budget, protocol deviation prevention, tracking and reporting; and IP management
- Regular oversight of key clinical metrics, including but not limited to: Days on Site (DOS), Monitoring Visit reports (MVR) and Follow up Letters (FUL) timelines, Action items (Al) and other quality metrics, to ensure they are met and followed-up as necessary
- Oversight of visit report review and approval, including site issue escalation and resolution
- Ensure clinical data is entered into the ICON CTMS in a timely manner
- Responsible for the maintenance of the Blinding Plan
- Ensure the core clinical portions of the Trial Master File are up-to-date and maintained in accordance with SOPs and the File Master Plan (FMp)
- Study Assignments: Non-DMID Portfolio
- Phase 2 multicenter, randomized, double-blind, placebo-controlled, multiple dosing interval, 2-period study of the safety, tolerability and effectiveness of adoptively transferred XXXX – XXXXX multivirus-specific T cells in kidney transplant recipients with either high or low levels of BK viremia
Clinical Trial Manager
ICON Clinical Research
Tampa, USA
11.2014 - 03.2021
- To act as the Functional Lead from Clinical Research Services with responsibility for delivery of all clinical aspects of clinical studies
- To oversee and serve as the liaison between the Project Manager and a group of Clinical Research Associates (CRAs) assigned to a given clinical study for the delivery of all aspects of monitoring and site management, ensuring consistency with ICH/GCP and applicable ICON and Sponsor Standard Operating procedures (SOps), ensuring monitoring and reporting of safety related events, applicable regulations, the Monitoring and ensuring the clinical portion of the study is inspection ready at all times
- May also act as a single service project manager, or as a project manager for small studies
- Study Assignments: DMID Research Portfolio
- A multi-study, multi-national, multi-center program supporting the Division of Microbiology and Infectious Diseases across their Clinical Research Operations Portfolio: DMID-CROMS
- Responsibilities: Countries handled: United States (37 sites – 4 protocols), Brazil (1 site – 1 protocol), Peru (1 site – 1 protocol), Uganda (1 site – 1 protocol), Papua New Guinea (1 site – 1 protocol), Kenya (2-sites – 1 protocol)
- Study stages handled: Study start-up, Monitoring, Study Closeout
- Study phases: I, II, IIa, IIb, III, IV
Associate Clinical Trial Manager
ICON Clinical Research
Tampa, USA
10.2013 - 11.2014
- Responsibilities include: acting as liaison between the Project Manager/CTM and a group of Clinical Research Associates
- Primary point of contact for assigned CRAs to ensure the delivery of site management activities from site selection to the close out visit, in adherence with ICH/GCP, SOPs, applicable regulations, Monitoring Plan and study contract/budget
- In addition, assisting the CTM in the development of study specific documents, providing training/mentoring to CRAs and ensuring a timely dissemination of information on study progress, issues, and/or processes to all team members related to the clinical deliverables
- Ensure accurate tracking of any relevant study information and assist the PM/CTM in implementing quality standards and ensuring compliance with study metrics requirement as set by the contract and the PM/CTM
- Study Assignments: DMID Research Portfolio
- A multi-study, multi-national, multi-center program supporting the Division of Microbiology and Infectious Diseases across their Clinical Research Operations Portfolio: DMID-CROMS
- Responsibilities: Countries handled: United States (6 sites – 6 protocols), South Africa/Africa (4 sites – 4 protocols), Philippines (2 sites – 2 protocols)
- Study stages handled: Study start-up, Monitoring, Study Closeout
Principal Clinical Research Associate
ICON Clinical Research
Tampa, USA
07.2010 - 10.2013
- Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies
- Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON Standard Operating Procedures/Working Procedures, applicable regulations and the principles of International Conference on Harmonization-Good Clinical Practices
- Involvement, when required, in other areas of study management and staff training
- Contribute to the review of ICON systems and procedures, as appropriate
- Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues
- Contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
- Recognize, exemplify and adhere to ICON’s values which centre around a commitment to People, Clients and Performance
- Independently and proactively coordinate the necessary activities required to set up and monitor a study
- Study Assignments: DMID Research Portfolio
- A multi-study, multi-national, multi-center program supporting the Division of Microbiology and Infectious Diseases across their Clinical Research Operations Portfolio: DMID-CROMS
- Responsibilities: Countries handled: United States (6 sites – 6 protocols), South Africa/Africa (4 sites – 4 protocols), Philippines (2 sites – 2 protocols)
- Study stages handled: Study start-up, Monitoring, Study Closeout
Senior Clinical Research Associate
ICON Clinical Research
Tampa, USA
10.2007 - 07.2010
- Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies
- Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON Standard Operating Procedures/Working Procedures, applicable regulations and the principles of International Conference on Harmonization-Good Clinical Practices
- Involvement, when required, in other areas of study management and staff training
- Contribute to the review of ICON systems and procedures, as appropriate
- Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues
- Contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
- Recognize, exemplify and adhere to ICON’s values which centre around a commitment to People, Clients and Performance
- Independently and proactively coordinate the necessary activities required to set up and monitor a study
Clinical Research Associate
J. Tyson and Associates
01.2006 - 10.2007
- Responsible for Interim Monitoring Visits
- Site Initiation and Closure Visits
- Assuring that GCP and regulatory guidelines are intact at each assigned site
- Chart review
- Essential Document Binders review
- Monitor case report forms
- Assist with query resolution
- Solicitation of adverse events for the research staff for reporting to the sponsor and IRB
- Study test article accountability
- Protocol development
Regulatory Affairs Associate
Taro Pharmaceuticals USA Inc.
08.2005 - 01.2006
- Responsibilities included reviewing annual reports, compiling and reviewing change controls for SOP’s, manufacturing procedures and specifications
- Compiling adverse events documentation as well as maintaining database of submitted 3500 and 3500A forms for FDA
- Drug listing for private labels as well as manufacturer, filing FDA correspondence and amendments, maintaining database for supplements and drug listing
- Responsible for preparing information pertaining to FDA forms 356h, 2252, 2658, and 2657 for relevant submissions
- Experience with reviewing DMF annual updates to FDA
- International experience with preparing CTD modules for FDA submission after compiling
Program Manager
The Chubb Institute
09.2003 - 08.2005
- Oversaw, monitored, and managed the quality and content of instruction of the clinical courses consistent with the program curriculum
- Ensured that the quality and quantity of instruction provided in the classroom and laboratory is consistent with the stated objectives of the school and industry
- Ensured that the program is operated in a cost effective and professional manner
- Assisted the Director of Education with the evaluation of the programs training curriculum so that it meets the needs of industry; participating in the revision, development, maintenance and implementation of existing and new programs
Co-Owner, Office Manager
Respiratory and Physical Therapy Clinic, El Salvador
01.2002 - 07.2003
- Spearheaded clinic’s marketing efforts to mid-range healthcare facilities
- Managed business office, including staffing, training and bookkeeping
Nurse Anesthetist
National Hospital of Pneumology and General Medicine Jose Saldana, El Salvador
03.1999 - 07.2003
- Responsible performing pre-operative patient assessments, educating patients about the effects of anesthesia, administering anesthetics under the supervision of an Anesthesiologist, maintaining appropriate levels of anesthesia during surgery, and checking on patients after they have been anesthetized
- Provided direct patient care to patients with acute illness, obstructive and restrictive diseases, emphysema, embolism, pulmonary edema, pneumothorax, and hemothorax in a 200 bed facility
- Monitored patient reactions to drugs and carefully documented their progress
- Performed respiratory therapy including nebulization, pulmonary function tests and arterial blood gas collection and process
- In charge of the collection and processing of arterial blood gases, as well as all respiratory diagnostic testing, and oxygenation
Education
Bachelor of Science - Nursing Anesthesiology
National University of El Salvador
Skills
- Registered Medical Assistant
- Medical Research Management
- Teaching Strategies
- Clinical monitoring
- Audit preparation
- Protocol development
- Training and mentoring
- Good clinical practice
- Trial oversight
- Reliability
- Multitasking Abilities
- Leadership skills
- Adverse event documentation
- Safety reporting
- Informed consent
- Critical Thinking
- Adaptability
- Time management abilities
Personal Information
Title: Sr. Clinical Trial Manager
Languages
- English, verbal and written
- Spanish, verbal and written
Company
ICON Clinical Research
Clinicalresearchtherapeuticareas
- Blood and Lymphatic System Disorders
- Cardiovascular
- Cellular Therapy
- Infections and Infestations
- Metabolism and Nutrition Disorders
- Musculoskeletal and Connective Tissue Disorders
- Nervous System Disorders
- Renal and Urinary Disorders
- Surgical and Medical Procedures
- Vaccines
- Vascular
Languages
English
Professional
Spanish
Professional
Timeline
Unblinded Clinical Trial Manager
ICON Clinical Research
09.2021 - 01.2023
Sr. Clinical Trial Manager
ICON Clinical Research
04.2021 - Current
Clinical Trial Manager
ICON Clinical Research
11.2014 - 03.2021
Associate Clinical Trial Manager
ICON Clinical Research
10.2013 - 11.2014
Principal Clinical Research Associate
ICON Clinical Research
07.2010 - 10.2013
Senior Clinical Research Associate
ICON Clinical Research
10.2007 - 07.2010
Clinical Research Associate
J. Tyson and Associates
01.2006 - 10.2007
Regulatory Affairs Associate
Taro Pharmaceuticals USA Inc.
08.2005 - 01.2006
Program Manager
The Chubb Institute
09.2003 - 08.2005
Co-Owner, Office Manager
Respiratory and Physical Therapy Clinic, El Salvador
01.2002 - 07.2003
Nurse Anesthetist
National Hospital of Pneumology and General Medicine Jose Saldana, El Salvador
03.1999 - 07.2003
Bachelor of Science - Nursing Anesthesiology
National University of El Salvador