Summary
Overview
Work History
Education
Skills
Certification
Volunteering Programs
Languages
References
Education And Publications
Therapeutic Areas
Timeline
Generic

Silvia Beluche de Rodriguez

Adelaide,SA

Summary

Dynamic manager with extensive experience at Santos Health, excelling in clinical trial management and customer relationship management. Proven track record in driving operational efficiency and fostering cross-functional teamwork, leading to improved service delivery and client satisfaction. Adept at resource allocation and data analysis, ensuring compliance and enhancing team performance.

Overview

21
21
years of professional experience
1
1
Certification

Work History

Manager FSP Business Unit

Santos Health
05.2021 - Current
  • Serve as the main point of contact with customers, building strong, collaborative relationships to ensure high levels of trust and satisfaction.
  • Oversee the performance and daily activities of a multifunctional team, ensuring excellent service delivery and adherence to the sponsor’s metrics.
  • Address non-compliance issues with appropriate action plans.
  • Manage team resource allocation, identifying needs, and resolving conflicts to ensure effective staffing.
  • Gather feedback from customers to continuously improve service delivery and strengthen relationships.
  • Proactively handle customer issues through proper escalation channels.
  • Ensure compliance with SOPs, work instructions, and federal/local guidelines, including ICH GCPs.
  • Conduct oversight visits for Clinical Research Associates as needed.
  • Maintain system updates and ensure adherence to relevant procedures and practices for both the customer and Santos Health processes.
  • Engage proactively with customers to discuss resource needs, and drive local account growth.
  • Make data-driven decisions regarding team members that positively impact business unit performance.
  • Share customer insights and best practices across the business unit to support the FSP 360 operating model.
  • Drive revenue growth by attracting, selecting, and retaining the right talent.
  • Assess and place talent on projects based on core competencies, margin impact, and alignment with customer requirements.
  • Participate in business unit account meetings, regional management team meetings, and Town Halls.
  • Provide line management for business unit team members, overseeing their performance through goal setting, reviews, and performance improvement plans.
  • Ensure team members adhere to training guidelines and maintain up-to-date training records, addressing both individual and corporate training needs.
  • Handle administrative oversight, including HR processes, timecards, and expense reports.
  • Assign project work, and review team members' workload and utilization.
  • Support professional development by coaching, providing growth opportunities, and helping team members create Individual Development Plans.
  • Work to maintain high levels of team engagement and retention, recognizing achievements, and fostering a culture of accountability.
  • Demonstrate a commitment to diversity, equity, and inclusion by developing staff, modeling inclusive behaviors, and managing bias proactively.
  • Delegated work to staff, setting priorities and goals.
  • Evaluated risk and issue trends across studies to develop improvement actions.
  • Implemented process improvements, resulting in an increase in operational efficiency.
  • Assessed the client's study-specific risk-based monitoring requirements to optimize resource utilization.

Sr. Clinical Research Associate II (assigned to BMS studies)

Santos Health
08.2020 - 04.2021
  • Conduct site qualification, initiation, interim monitoring, site management, and close-out visits, ensuring compliance with regulatory standards, ICH-GCP, and Good Pharmacoepidemiology Practices (GPP)
  • Evaluate site and staff performance, make site-specific recommendations, and escalate serious issues to the project team while developing action plans
  • Maintain knowledge of ICH/GCP guidelines, relevant regulations, and company SOPs/processes
  • Ensure that the process of obtaining informed consent is properly conducted and documented for each subject/patient
  • Maintain strict confidentiality for all subjects/patients
  • Evaluate potential factors at the investigator/physician site that could impact subject/patient safety and the integrity of clinical data, including protocol deviations/violations and pharmacovigilance issues
  • Follow the Clinical Monitoring Plan to assess site processes and review source documents and medical records
  • Verify the accuracy and completeness of clinical data in case report forms (CRFs)
  • Resolve data queries promptly, providing guidance to site staff
  • Ensure compliance with electronic data capture requirements using appropriate technology
  • Perform inventory and reconciliation of investigational products (IP) and review their storage and security
  • Ensure IP is dispensed and administered according to protocol, and address issues or risks related to blinded or randomized information
  • Apply GCP, local regulations, and organizational procedures to ensure proper labeling, importation, and handling of IP
  • Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness
  • Reconcile contents of the ISF with the Trial Master File (TMF) to be audit ready
  • Understand project scope, budgets, and timelines for own and others' activities in the clinical team; manage site-level activities / communication to ensure project objectives, deliverable
  • Provide direct supervision, training and/or mentorship to more junior level CRAs
  • Perform training and sign off visits for junior CRA staff

Clinical Operation Lead (Early Phase)

Santos Health
03.2019 - 08.2020
  • Manage start-up, monitoring, and site closure for Phase 1 clinical projects, including site initiation, monitoring, and visit reporting
  • Assist with recruiting and onboarding new staff
  • Guide team on prioritizing activities and managing study budgets
  • Oversee resource allocation, resolve staffing conflicts, and use GRM tools
  • Ensure quality and progress of clinical monitoring and site management, including developing Clinical Management Plans (CMP)
  • Interact with clients and departments to manage clinical activities and ensure alignment with budgets
  • Participate in business development, training delivery, and proposal development
  • Review Clinical Trial Management System (CTMS), CRF, drug management, and other tools to monitor site and study team conduct
  • Ensure thorough site process assessments, Source Document Verification (SDV), and risk management, executing corrective action plans as needed
  • Collaborate with other functional leaders to ensure site compliance with protocols, regulations, and readiness for inspections

Sr. Clinical Research Associate II (assigned to Pfizer studies)

Santos Health
08.2017 - 03.2019
  • Conduct site visits (qualification, initiation, monitoring, and close-out) to ensure regulatory and protocol compliance
  • Evaluate site performance, resolve issues, and stay updated on guidelines
  • Oversee informed consent procedures, maintain confidentiality, and address safety and data integrity issues
  • Review site processes, source documents, and CRF data; resolve queries and ensure electronic data capture compliance
  • Manage investigational product inventory and security checks, ensuring proper dispensation and handling of Investigational Product
  • Review and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF) for audit readiness
  • Manage project scope, budgets, and timelines; supervise and train junior CRAs

Sr. Clinical Research Associate II

CPR Pharma Service (currently Avance Clinical)
05.2015 - 08.2017
  • Monitor Phase I and Phase II studies to ensure compliance with GCP, study protocol and regulatory requirements
  • Autonomously perform all aspects of study initiation, on-study activities and study closure, including the reports
  • Prepare ethics and regulatory submissions
  • Manage independently clinical study sites
  • Mentor and train other staff members as required
  • Develop and review clinical study plans, communication plan, clinical monitoring plan and other study related documents (pharmacy and laboratory manuals)
  • Commitment to CPR's training programs
  • Perform internal audits of CPR documents and SOP

Local and Regional Clinical Project Manager (LATAM)

AstraZeneca Venezuela
12.2010 - 01.2014
  • Support CRAs and Sr CRAs with study feasibility and site selection
  • Assist with telephone screenings, site questionnaires, and regulatory document reviews
  • Help organize and attend investigator meetings
  • Conduct site management activities, including qualification, initiation, training, monitoring, and close-out visits
  • Revise study visit reports and follow-up letters as per SOPs
  • Coordinate shipment of clinical supplies and study drugs with the CRA and Project Assistant
  • Follow up on drug safety issues and safety reports
  • Communicate site issues and progress to the Medical Director
  • Review Case Report Forms and assist with data query resolution
  • Maintain study information in tracking systems (IMPACT) and attend project team meetings
  • Perform monthly visits to oversee CRA activities and manage study budgets using ACCORD and SAP
  • Contribute to writing clinical protocols and manage the overall study budget
  • Ensure staff training, risk assessment, patient recruitment plans, and data accuracy on clinicaltrials.gov
  • Organize international meetings for study start-up and Medical Steering Committee discussions
  • Develop communication plans with the marketing department for each participating country

Clinical Project Coordinator

AstraZeneca Venezuela
12.2007 - 12.2010
  • Perform monthly accompanied visits to supervise the monitoring activities for each CRA
  • Organize Ethics committee submissions with follow through to ensure successful outcome
  • Ensure clinical trials were initiated on time by supervising dossiers to be submitted to local Minister of Health in order to obtain country approval
  • Maintain frequent telephone communication with sites, providing guidance on operational site issues to nurses and investigators as necessary and in agreement per monitoring plan
  • Maintain adequate site tracking records
  • Follow up of drug safety issues and safety reports in timely manner
  • Analyze and complete feasibility questionnaires for each global clinical trial in order to run it locally
  • Manage global policies and standard operating procedures
  • Assist with the control and tracking of project milestones
  • Ensure all data systems were completed accurately and on time
  • Ensure patient recruitment strategies were in place
  • Prepare budgets (using SAP and ACCORD system)
  • Fulfilled monthly report for monitoring resources with the financial department

Clinical Research Associate

Pfizer Venezuela
04.2004 - 12.2007
  • Collaborate with project analyst to prepare regulatory file
  • Perform initiation, monitoring and close out visits, perform source data verification as per protocol guidelines
  • Coordinate the logistic of protocol implementation at the sites (local and international meeting)
  • Coordinate and ensure good handling of study drug to sites
  • Ensure all data systems were completed accurately and on time
  • Follow up safety findings with the site

Education

Post Graduate Diploma - Business Management

Universidad Simon Bolivar
Venezuela
10.2009

Bachelor - Pharmacy

Universidad Central de Venezuela
Venezuela
12.2002

Skills

  • Customer relationship management
  • Regulatory compliance
  • Clinical trial management
  • Data analysis
  • Team leadership
  • Resource allocation
  • Communication skills
  • Problem solving
  • Cross-functional teamwork

Certification

  • 02/24, Diploma Empowered Leader Program
  • 01/24, First Time Manager Journey
  • 12/23, Clifton Strengths 34 Results

Volunteering Programs

  • 2021 - ongoing, ASIAN Employee Resource Group at Santos Health, active co-lead member
  • 2017 - ongoing, CRA Trainer and Assessor

Languages

  • English
  • Spanish (native)
  • German (basic)

References

Available upon request

Education And Publications

  • 10/13, Comparison of treatment of bipolar disorder between the Venezuelan cohort and the total population of a large multinational longitudinal study (WAVE-bd). 26th ECNP Congress. Barcelona, Spain
  • 10/09, Universidad Simon Bolivar – Venezuela Post Graduate Diploma - Business Management
  • 12/02, Universidad Central de Venezuela - Venezuela Bachelor – Pharmacy

Therapeutic Areas

  • Analgesia: Pain, Osteoarthritis and Anesthesiology - Sciatic Pain
  • CNS Psychiatry: Bipolar Disorder
  • Cardiovascular: Cardiovascular - Cholesterol-Lowering
  • Dermatology: Alopecia, Areata
  • Endocrinology: Endocrinology - Type 1 Diabetes Mellitus
  • Neurology: Stroke, Acute Ischemic
  • Oncology: Hematologic Malignancies, Hepatocellular, Lung Non-Small Cell, Prostate and Solid Tumors Cancer
  • Respiratory: Chronic Obstructive Pulmonary Disease

Timeline

Manager FSP Business Unit

Santos Health
05.2021 - Current

Sr. Clinical Research Associate II (assigned to BMS studies)

Santos Health
08.2020 - 04.2021

Clinical Operation Lead (Early Phase)

Santos Health
03.2019 - 08.2020

Sr. Clinical Research Associate II (assigned to Pfizer studies)

Santos Health
08.2017 - 03.2019

Sr. Clinical Research Associate II

CPR Pharma Service (currently Avance Clinical)
05.2015 - 08.2017

Local and Regional Clinical Project Manager (LATAM)

AstraZeneca Venezuela
12.2010 - 01.2014

Clinical Project Coordinator

AstraZeneca Venezuela
12.2007 - 12.2010

Clinical Research Associate

Pfizer Venezuela
04.2004 - 12.2007

Post Graduate Diploma - Business Management

Universidad Simon Bolivar

Bachelor - Pharmacy

Universidad Central de Venezuela

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Silvia Beluche de Rodriguez