Sara Gonzales
Austin,USA
Summary
Director leading global clinical research programs across Phases I-IV, from RFP shaping and feasibility through activation, monitoring, and closeout. Aligns cross-functional teams, regional stakeholders, and governance forums to keep delivery on plan across North America, Europe, and APAC. Drives risk management, resource alignment, and executive decision support to keep complex programs moving forward.
Overview
2
2
Languages
1
1
Certification
25
25
years of professional experience
Work History
PROJECT DIRECTOR, GLOBAL PROJECT MANAGEMENT
SYNEOS HEALTH
AUSTIN, TX, USA
11.2024 - Current
- Oversee portfolio-level budgets, financial forecasting, and margin goals
- Lead strategic bid defense meetings to secure new business.
- Negotiate scope changes and contract modifications with sponsors
- Intervene proactively on high-risk trials or critical operational bottlenecks
- Monitor delivery timelines, quality metrics, and cost constraints across projects
- Develop and implement project management frameworks to enhance operational efficiency
- Establish key performance indicators to measure project success and drive continuous improvement initiatives
- Lead preparation of bid packages and associated scopes of work, appendices and exhibits
- Expand the company's client base by successfully delivering high-quality projects that showcased the organization's capabilities and expertise in project management.
- Streamline communication processes between stakeholders, improving collaboration and project outcomes
ASSOCIATE DIRECTOR, GLOBAL PROGRAM MANAGER
PPD
AUSTIN, TEXAS, USA
05.2022 - 11.2024
- Managed communication between the sponsor and CRO at the program level; guided project managers to align with the program's objectives
- Led cross-functional teams to enhance project delivery timelines and quality standards
- Developed and implemented strategic plans to improve operational efficiency across projects
- Improved overall team efficiency by streamlining project management processes and implementing new collaboration tools
- Managed cross-functional teams for multiple large-scale projects, successfully completing each on time and within budget constraints
- Mentored junior staff, fostering professional growth and enhancing team performance
SENIOR PROJECT MANAGER
PPD
AUSTIN, TX, USA
04.2021 - 05.2022
- Led cross-functional teams to execute complex clinical project timelines and deliverables
- Developed and implemented project management methodologies to enhance operational efficiency
- Established strong relationships with clients, enhancing satisfaction through proactive engagement and support
- Maintained schedules to meet key milestones at every project phase
- Developed comprehensive project plans, identifying risks and mitigation strategies for timely completion
- Conducted risk assessments and implemented mitigation strategies to ensure project success
PROJECT MANAGER
PPD
AUSTIN, TX, USA
02.2017 - 03.2021
- Led cross-functional teams to deliver projects on time and within budget
- Provided detailed project status updates to stakeholders and executive management
- Developed project plans, timelines, and resource allocation strategies for complex initiatives
- Implemented risk management processes to identify and mitigate potential project challenges
- Streamlined communication between stakeholders, enhancing collaboration and project visibility
- Utilized project management software to track progress, manage resources, and report status updates effectively
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals
DIRECTOR OF CLINICAL RESEARCH & LAB DIRECTOR
NEUROLOGY CONSULTANTS OF DALLAS
DALLAS, TX, USA
01.2013 - 12.2016
- Managed a team of 13 to streamline research operations and enhance project efficiency
- Oversaw compliance with regulatory standards, ensuring adherence to ethical guidelines in all studies
- Established performance metrics to evaluate team productivity and identify areas requiring improvement
- Led efforts to maintain a strong quality assurance program, conducting regular audits and implementing corrective measures as needed
- Enhanced patient safety by rigorously monitoring adverse events and promptly addressing any concerns
- Negotiated contracts with CROS ensuring timely competitive compensation while maintaining high-quality standards
CLINICAL PROJECT MANAGER
LS CLINICAL TRIAL MANAGEMENT - No Longer in Business
OAK PARK, IL, USA
01.2007 - 01.2013
- Managed project timelines, resources, and quality from site selection through closeout
- Coordinated cross-functional teams to facilitate effective communication and collaboration throughout trial phases
- Led cross-functional teams to execute clinical trial protocols efficiently
- Managed timelines and resources for multiple clinical studies simultaneously
- Facilitated strong relationships between study sites, sponsors, and internal teams through regular updates and effective communication strategies
- Conducted regular status meetings to review progress, address challenges, and adjust strategies accordingly
CLINICAL RESEARCH ASSOCIATE
LS Clinical Trial Management - No Longer in Business
OAK PARK, IL, USA
01.2003 - 01.2007
- Monitored clinical trial progress, ensuring adherence to protocols and regulatory compliance
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables
- Conducted site visits to assess data integrity and monitor patient recruitment efforts
- Trained junior staff on clinical trial procedures, enhancing team performance and knowledge retention
- Maintained site monitoring schedules to facilitate effective communication with members of the clinical team
CLINICAL TRIAL ASSISTANT
LS Clinical Trial Management - No Longer in Business
OAK PARK, IL, USA
01.2002 - 01.2003
- Facilitated communication between cross-functional teams to streamline project workflows and resolve issues efficiently.
- Implemented tracking systems for participant recruitment, enhancing operational efficiency in enrollment processes.
- Acted as a liaison between clinical sites and sponsors for effective communication regarding protocol amendments, enrollment updates, or other pertinent information related to trials.
- Assisted in the development of study-specific materials
Education
B.S. - Neuroscience, Chemistry, Psychology
Dominican University
River Forest, IL, USA01.2011
Skills
- Stakeholder management
- RFP development
- Agile project management
- Performance monitoring
Accomplishments
- Achieved Database Lock in 8 business days by managing a team with agility and efficiency
- Led team of 50+ colleagues
- Achieved First Site Activation and First Patient Enrolled in 52 calendar days with 11 vendors through effectively driving the team forward with flexibility and strategic mitigations
- Financial Management including resource forecast of a $660M program
Certification
- CITI: Biomedical Research & GCP
- PPD Biotech University Certificate Program, 2021, 2023
LANGUAGES
Native Tongue: English
Proficient: Spanish (verbal and written)
Timeline
PROJECT DIRECTOR, GLOBAL PROJECT MANAGEMENT
SYNEOS HEALTH
11.2024 - Current
ASSOCIATE DIRECTOR, GLOBAL PROGRAM MANAGER
PPD
05.2022 - 11.2024
SENIOR PROJECT MANAGER
PPD
04.2021 - 05.2022
PROJECT MANAGER
PPD
02.2017 - 03.2021
DIRECTOR OF CLINICAL RESEARCH & LAB DIRECTOR
NEUROLOGY CONSULTANTS OF DALLAS
01.2013 - 12.2016
CLINICAL PROJECT MANAGER
LS CLINICAL TRIAL MANAGEMENT - No Longer in Business
01.2007 - 01.2013
CLINICAL RESEARCH ASSOCIATE
LS Clinical Trial Management - No Longer in Business
01.2003 - 01.2007
CLINICAL TRIAL ASSISTANT
LS Clinical Trial Management - No Longer in Business
01.2002 - 01.2003
B.S. - Neuroscience, Chemistry, Psychology
Dominican University
PUBLICATIONS AND PRESENTATIONS
- Presentations:
- Dominican University, Department of Neuroscience: Undergraduate Research and Creative Investigation (URCI). Poster Presentation 2010. Transcriptional Control of Alpha Tubulin in an Aplysia Sensitization Model.
- Dominican University, Department of Neuroscience: Undergraduate Research and Creative Investigation (URCI). Poster Presentation 2011. Coenzyme A.
- Annual Student Scholarship Symposium on behalf of Associated Colleges of the Chicago Area (ACCA): Presentation 2011. Midwifery: Everything Old is New Again.