America Vega Y Rojo
Mexico City
Summary
Knowledgeable Sr. Clinical Trial Manager with solid background, 25 years, in managing clinical trials from Feasibility to Closure and Clinical Report finalization. Experience includes two years as Project Manager, fourteen years as Clinical Trial Manager, Regional and Global, two years in Quality Assurance, two years as Team Leader, nine years as Clinical Research Associate overseeing clinical activities in the United States, Canada, Hungary, Switzerland, Poland, Spain, Mexico, Peru, Brazil, Colombia, Chile, Puerto Rico, Panama, Argentina, Korea and Australia.
Successfully led global and regional diverse teams, ensuring compliance with regulatory standards and optimizing trial efficiency.
Demonstrated expertise in risk management.
Expert in streamlining trial processes, achieving recruitment targets, and fostering cross-functional teamwork.
Excelling in budget oversight and stakeholder communication.
Recognized for enhancing data quality and implementing effective resource allocation strategies to drive successful clinical outcomes.
Experienced with overseeing clinical trials to ensure adherence to regulatory guidelines and protocols.
Utilizes strong project management skills to streamline trial processes and enhance operational efficiency.
Track record of effectively managing cross-functional teams and mitigating risks in clinical research.
Therapeutic Experience includes: Oncology, Dermatology, Cardiovascular, Endocrinology, Infectious Diseases, Medical Genetics, Nephrology, Ophthalmology, and Devices.
Overview
23
23
years of professional experience
Work History
Sr. Clinical Trial Manager
IQVIA Biotech
10.2021 - Current
- Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
- Reduced operational costs through effective budget management, negotiation with vendors, and careful allocation of resources.
- Contributed to Bid Defenses , ensuring clinical activities are understand from the client and that this meets research objectives while adhering to ethical standards and regulations.
- Streamlined trial management processes from Feasibility to Closure for increased efficiency through diligent organization and coordination of site selection and resources allocation.
- Prepared detailed project plans (Clinical Monitoring Plan, Communication Plan, Filing Plan, Safety Plan) assuring that company and client SOPs are followed.
- Prepare detailed progress reports for sponsors and stakeholders, keeping them apprised of key developments in ongoing trials.
- Evaluated vendor performance regularly to ensure high-quality services were provided throughout the duration of the clinical trial.
- Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
- Developed training materials for site staff to enhance their understanding of the study protocol, resulting in improved adherence to requirements.
- Spearheaded the selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Achieved successful recruitment targets by implementing strategic patient enrollment plans and collaborating with study sites.
- Implemented risk management strategies, effectively minimizing potential threats to the success of clinical trials.
- Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
- Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
- Supported the preparation of clinical study reports by providing accurate data analysis and interpretation for inclusion in final documentation.
- Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
- Enhanced patient safety by meticulously monitoring clinical trial activities and promptly addressing any issues.
- Championed continuous improvement initiatives within the organization by sharing best practices and lessons learned from previous trials with colleagues and team members.
- Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
- Gathered, processed, and shipped lab specimens.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Complied with research protocols by providing ongoing quality control audits.
- Collected, evaluated, and modeled collected data.
- Monitored unit budget to meet financial objectives for spend rate and funding.
Regional Project Manager
Tigermed Therapy
06.2021 - 09.2021
- Balanced competing priorities effectively, successfully managing multiple projects simultaneously within tight deadlines and budget constraints.
- Ensured consistent compliance with industry regulations by staying current on relevant laws and best practices.
- Promoted a culture of continuous improvement within the project team by actively seeking feedback from all stakeholders involved.
- Managed cross-functional teams to ensure timely project completion and optimal resource utilization.
- Led regional expansion initiatives, overseeing successful integration of new business units into existing operations.
- Cultivated strong relationships with stakeholders, resulting in increased collaboration and project success.
- Evaluated vendor proposals, negotiating contracts that maximized value while minimizing costs for the organization.
Sr. Clinical Trial Manager
PPD
03.2019 - 06.2021
- Streamlined Clinical trial management processes for increased efficiency from Feasibility to Closure phases through diligent organization and coordination of clinical trial activities and resources allocation.
- During this period, I oversaw all clinical monitoring efforts of 5 global studies, different indications: multiple osteochondromas, progresive fibrodysplasia ossifications, ulcerative colitis and chronic inflammatory diseases.
- On charge of global clinical team, integrated by 15 CRAs across 11 countries ad 85 sites.
Clinical Trial Manager
ICON Plc
09.2013 - 09.2018
- Streamlined trial management processes for increased efficiency through diligent organization and coordination of clinical activities from Feasibility to Closure and resources allocation.
- Prepared detailed progress reports for sponsors and stakeholders, keeping them apprised of key developments in ongoing trials.
- Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
- Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
- Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
- Responsible of 3 clinical trials in Latam Region, provided leadership and management o a monitoring team of 10 CRA´s and CTAs.
Project Manager and Quality Assurance
Accelerted Clinical Research
01.2011 - 04.2013
- Successfully managed multiple device projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Planned, designed, and scheduled phases for devices projects.
- Delivered exceptional customer satisfaction by proactively addressing client concerns and meeting or exceeding expectations throughout the engagement process.
- Met project deadlines.
- Established effective communication among team members for enhanced collaboration and successful project completion.
- Collaborated closely with senior management to align project objectives with strategic company initiatives, ensuring that efforts contributed to overall business growth.
Team Leader and Sr. CRA
INC Research
08.2006 - 12.2010
- Set performance expectations for the team, monitoring progress towards goals and providing constructive feedback as needed.
- Empowered team members by delegating responsibilities according to individual strengths and areas of expertise.
- Managed conflict resolution among team members, fostering a positive and collaborative work environment.
- Maintained an inclusive and diverse team culture, promoting respect and understanding among all members.
- Complete all Sr. Clinical Research Activities.
Senior Clinical Research Associate
Sanofi
08.2002 - 08.2006
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Communicated project status to Project Manager through technical documentation and presentations.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Achieved project objectives by troubleshooting experiments and testing practical and creative solutions.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Managed project risk by identifying, quantifying and monitoring potential threats.
Clinical Research Associate
Eli Lilly
12.2001 - 11.2002
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
Education
Bachelor of Science - Nutrition Sciences
Universidad Autonoma Metropolitana
Mexico City, Mexico07-1996
Skills
- GCP certification preparation
- Coaching and guidance
- Oversight of clinical studies
- Customer engagement expertise and effective stakeholder communication
- Goal-focused
- Cross-functional teamwork
- Critical thinking and analysis
- Prioritization and scheduling
- Detail-oriented approach
- Proficient in handling multiple priorities
- Trustworthy execution
- Excellent communication
- Critical thinking
- Organizational skills
- Focused listening
- Budget and resource oversight
- Effective resource allocation
Languages
English
Bilingual or Proficient (C2)
Spanish
Bilingual or Proficient (C2)
Timeline
Sr. Clinical Trial Manager
IQVIA Biotech
10.2021 - Current
Regional Project Manager
Tigermed Therapy
06.2021 - 09.2021
Sr. Clinical Trial Manager
PPD
03.2019 - 06.2021
Clinical Trial Manager
ICON Plc
09.2013 - 09.2018
Project Manager and Quality Assurance
Accelerted Clinical Research
01.2011 - 04.2013
Team Leader and Sr. CRA
INC Research
08.2006 - 12.2010
Senior Clinical Research Associate
Sanofi
08.2002 - 08.2006
Clinical Research Associate
Eli Lilly
12.2001 - 11.2002
Bachelor of Science - Nutrition Sciences
Universidad Autonoma Metropolitana
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