Alejandra Blanco Gómez
Santiago ,Chile
Summary
Hardworking and passionate job seeker with strong organizational and leadership skills eager to the position. Ready to help team achieve company goals.
Overview
28
28
years of professional experience
Work History
Dir, Clinical Trial Mgmt, Delivery Lead
Syneos Health
04.2022 - Current
- Provides expert monitoring strategy, oversight and guidance to support internal teams and sponsors, especially in Clinical &RBM strategy.
- Manage Clinical trials managers worldwide. Providing operational oversight and guidance. Support overall staff growth, participate in selection and hiring process. Proactively works to ensure staff retention. Oversees progress of teams supporting clinical projects.
- Functions as point of escalation for clinical, central monitoring, RBM and project risks and issues.
- Participates in work streams to support development and implementation of new initiatives and strategic direction of BU, cross-BU Clinical Operations and cross-functionally.
- Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH GCP
- Develops and supports customer relationships, manage customer expectations and escalates more serious risks and issues as required
- Provides support to Business Development to facilitate new project awards during Bid Defense process. Participates in marketing activities, client presentations and proposal development, audits.
- Country head and legal responsibilities for Chilean affiliate.
Director Clinical Monitoring
Syneos Health (formerly Inventiv Health)
08.2014 - 04.2022
- Manage professional employees who work on clinical trial projects as Clinical trial managers in region.
- Identify, address and follow up on performance and quality issues.
- Track and report both departmental and customer metrics.
- Provide business development support.
- Provide input into financial forecasts and review invoices for accuracy.
- Participate in interview and hiring process.
- Coordinate and conduct new employee orientation and training.
- Country head and legal responsibilities for Chilean affiliate.
Associate Director
PharmaNet-i3 (an inVentiv Health Company)
03.2012 - 07.2014
- Led teams of up to 20 personnel at regional level, CRAs and Clinical Trial Managers supervising daily performance as well as training and improvement plans.
- Set priorities and scheduled activities of departmental resources, implemented company objectives, and created alternative solutions to address business and operational challenges.
- Created and provided input into financial forecasts and review invoices for accuracy.
- Communicated with external customers & vendors regarding projects.
- Resolved customer relationship issues and escalate more serious issues when necessary.
- Participated in committees and work groups to support development and implementation of new initiatives and strategic direction of department.
- Participated in interview & hiring process.
- Fostered culture of continuous improvement by encouraging staff to share innovative ideas and providing resources for professional development.
- Country head and legal responsibilities for Chilean affiliate.
Regional Manager
i3 Research
03.2007 - 02.2012
- Provided guidance and support to regional monitoring personnel, including coordinating new employee orientation and training, serving as resource and mentor for monitoring questions/issues/local regulatory requirements, providing guidance regarding company policies and procedures, identifying and addressing performance issues and training needs, conducting ongoing performance evaluations, maintaining office (e.g., procurement of office supplies, submission of documents), performing routine performance assessment/training visits to evaluate on-site performance, and performing management-related administrative duties.
- Collaborated with executive leadership to establish long-term objectives, drive growth initiatives, and align regional efforts with corporate goals.
- Country head and legal responsibilities for Chilean affiliate.
Country Manager
LatinTrials
09.2005 - 02.2007
- Reported to General Manager all Administrative, Accounting and Logistics activities done in Subsidiary and to Clinical Operations Director (COD) all Clinical Operations activities done in Subsidiary.
- Coordinated and supervised Clinical Operations activities done at Chilean office. Managed CRAs, including Lead, Senior, Semi Senior CRA and Junior CRAs (CRAs) and administrative personnel under my responsibility including recruited, trained and coached members team to support company growth.
- Ensured that clinical trials are conducted in agreement with requirements of Sponsor, GCP-ICH and applicable SOPs and international/ local regulations,
- Provided necessary information feasibility studies and Audits.
- Interacted with Sponsor and/or third-party vendors or PM to ensure study materials availability.
- Country head and legal responsibilities for Chilean affiliate.
Clinical Research Associate
Latin Trials
05.2003 - 08.2005
- Conducted pre study, initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion and all inherent activities related to the role.
- Experience monitoring in most of LATAM countries,
- Was a temporary backup of the PM when there was no Lead CRA in the Team.
Clinical Research Associate
Wyeth Laboratories
03.2003 - 05.2003
- Training and interim monitoring visits.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Co-Investigator and Study Coordinator
Instituto de Nutrición y Tecnología en Alimentos( INTA)- Hospital Sótero del Río
12.2001 - 03.2003
- Performed all activities related a study coordinator and Sub- Investigator in pediatrics studies including neonates half day work.
Clinical Research Associate
Pharmacia Corporation de Chile
10.2002 - 02.2003
- Performed routine site visits, including pre-study, initiation, interim, and closeout visits.
- Reviewed clinical data, source documentation, case report forms, SAEs reporting and investigative site regulatory files to verify accuracy and completion.
- Half day position
Study Coordinator and Research Nurse
Instituto De Nutrición Y Tecnología En Alimentos Hospital Dr. Sotero Del Río
03.1999 - 12.2001
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Coordinated and monitored all clinical trial activities to support timely and accurate completion of studies ensuring quality and regulatory compliance.
Neonatology's Registered Midwife
Hospital Sotero del Rio
03.1996 - 07.1999
- Attending midwife for immediate attention, basic services and intensive care in Neonatology's service.
- Supervised drugs management and equipment in neonatology's service
- Supervised personnel
Education
Certificate - Storytelling
Universidad Del Desarollo
Santiago De Chile2023
Certificate - Leading Teams
Zenger Folkman
United States2017
Post Graduate Diploma Negotiation And Coaching -
Universidad Catolica
Santiago De Chile2010
Post Graduate Diploma in Strategic Leadership. - Organizational Leadership
Universidad Adolfo Ibañez
Santiago De Chile2006
Post Graduate Diploma - Diploma Administration of Health Services
Universidad De Los Andes
Santiago De Chile1999
Bachelor of Science - Midwifery
Universidad De Chile
Santiago De Chile12.1992
Skills
- Friendly, Positive Attitude,
- Adaptable to changing environments
- Teamwork and Collaboration
- Customer Service
- Problem-Solving
- Time Management
- Attention to Detail
- Dependable and Responsible
- Critical Thinking
- Organizational Skills
- Calm Under Pressure
- Decision-Making
- Problem Resolution
Accomplishments
- Achieved the team embraced all new dashboards and financial knowledge of study budgets and overburns related to clinical operations.
- Supervised team of 20-27 staff members in USA- Europe and LATAM (mainly Europe).
- Obtained a seasonal project approval in the country in 8 weeks.
- Participation in Global initiatives as SOP reviewer for Clinical operations in Associate Director position, Preparation of all LATAM audits with CRAs as Regional manager and responsible of implementation of corrective actions.
Languages
English
Advanced (C1)
Spanish
Bilingual or Proficient (C2)
Coaching, trainer experience
- Since 2009 Professor in post graduate program at Universidad the Chile that leads to certified monitors- Modules of clinical monitoring and regulatory.
- 2006-2008 Coach at monitor foundation program, coaching 2-3 CRAs each year. program of 6 months each,
Publications & Presentations
- Effects of pasteurized human milk vs. formula in the VLW prematures during the first 28 days. M.Milad, P.Mena. A. Blanco. Presented in I Chilean congress of neonatology. Chile. August, 2004.
- IGF-1 and Leptin Levels in VLBW Children, Growth up to 12 Months Corrected Age. P. Mena, A. Blanco, M.C. Pinzón, A. Alegria, E. Jiménez, F. Perez. XLI Chilean Pediatrics Congress. November 2001
- Implementing a Human Milk Banking in a NICU, Hospital Dr. Sótero del Río- Instituto de Salud Pública. P. Mena, M. Milad, A. Blanco, R. Meneses, Mónica Insunza. XLI Chilean Pediatrics Congress. November 2001. Served as presenter of a poster and co-author
- Mena P., Pittaluga E., Blanco A., Castillo C., Taboada H. Vitamin B12 does not modify the evolution of anemia in prematures. Revista Chilena de Pediatría 72 (1) 34-39, 2001.
- Nutritional Evolution in Very Low Weighted Suckling at Birth, Fed with Special formula for Prematures on their First Year. Presented in the XXXIX ChileanPediatrics Congress held in Iquique, Chile. October 1999. Served as co-author.
- The Effects of Supplementary Vitamin B12 in Anemic Prematures. XI Latin American Congress within the XVIII Pan American Pediatrics Congress, and XXXVIII Chilean Pediatrics Congress, April 1998. Served as co-author.
Timeline
Dir, Clinical Trial Mgmt, Delivery Lead
Syneos Health
04.2022 - Current
Director Clinical Monitoring
Syneos Health (formerly Inventiv Health)
08.2014 - 04.2022
Associate Director
PharmaNet-i3 (an inVentiv Health Company)
03.2012 - 07.2014
Regional Manager
i3 Research
03.2007 - 02.2012
Country Manager
LatinTrials
09.2005 - 02.2007
Clinical Research Associate
Latin Trials
05.2003 - 08.2005
Clinical Research Associate
Wyeth Laboratories
03.2003 - 05.2003
Clinical Research Associate
Pharmacia Corporation de Chile
10.2002 - 02.2003
Co-Investigator and Study Coordinator
Instituto de Nutrición y Tecnología en Alimentos( INTA)- Hospital Sótero del Río
12.2001 - 03.2003
Study Coordinator and Research Nurse
Instituto De Nutrición Y Tecnología En Alimentos Hospital Dr. Sotero Del Río
03.1999 - 12.2001
Neonatology's Registered Midwife
Hospital Sotero del Rio
03.1996 - 07.1999
Certificate - Storytelling
Universidad Del Desarollo
Certificate - Leading Teams
Zenger Folkman
Post Graduate Diploma Negotiation And Coaching -
Universidad Catolica
Post Graduate Diploma in Strategic Leadership. - Organizational Leadership
Universidad Adolfo Ibañez
Post Graduate Diploma - Diploma Administration of Health Services
Universidad De Los Andes
Bachelor of Science - Midwifery
Universidad De Chile
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