Gaston Lopez Email and Phone Number
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Highly motivated and results-oriented Clinical Research professional with 16+ years of experience driving operational excellence in clinical trials. Proven ability to lead and manage cross-functional teams, optimize processes, and deliver projects on time and within budget. Expertise spans all phases of clinical research, from hands-on patient care as a Clinical Research Coordinator to strategic oversight of global clinical programs as a Clinical Program Director. Adept at fostering collaboration and building strong relationships through charismatic and empathetic communication, leveraging expertise across all functions to achieve efficient study execution and advance drug development across multiple therapeutic areas, including Hepatology (NASH), Metabolic disorders (MMA & PA), Neuroscience, Gastroenterology, Cardiovascular Nephrology, Pulmonology, and vaccine studies. Demonstrating strong self-management, communication, and presentation skills honed over 12 years of remote work experience.
Takeda
View- Website:
- takeda.com
- Employees:
- 36992
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Senior Clinical Operations ManagerTakedaWilmington, Nc, Us
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Clinical Program Director, Clinical OperationsHemoshear Therapeutics Jan 2021 - Jan 2024• Responsible for overseeing and leading all clinical studies at HemoShear.• Lead study operations, providing strategic/tactical planning, organization, and direction.• Oversee timelines, finances, monitoring, site and vendor management.• Negotiate budgets and change orders, manage clinical supplies, and collect and analyze data.• Create policies, work instructions, and contribute to protocol development and other study-related documents.• Foster positive relationships between HemoShear study team, CRO, and study sites.• Ensure audit readiness and perform other essential daily tasks.
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Clinical Project DirectorPra Health Sciences Jun 2020 - Dec 2020Raleigh, North Carolina, Us• Owned and achieved interim and final contractual deliverables for assigned projects/programs.• Led cross-functional teams, managed client expectations, and resolved/mitigated risks and issues.• Adhered to PRA standard procedures and processes.• Acted as the primary liaison with clients and directed cross-functional teams.• Managed project contractual deliverables and costs.• Ensured adherence to company SOPs, policies, and guidelines.• Developed operational strategies and mentored team members.• Maintained awareness of business unit’s and assigned projects’ therapeutic environment. -
Senior Clinical Project ManagerSyneos Health (Previously Inc Research/Inventiv Health) Sep 2018 - Jun 2020Morrisville, Nc, Us• Provided customer-focused leadership in managing and delivering the operational and financial aspects of clinical projects.• Oversaw various clinical projects, from proposal development to final deliverables, across different phases and functional areas.• Led less experienced Project Managers and had line management responsibilities.• Ensured compliance with Good Clinical Practices (GCPs) and relevant Standard Operating Procedures (SOPs).• Acted as the primary liaison between the Company and the Customer.• Ensured quality, timelines, and budget management.• Developed strong client relationships and generated new business.• Participated in bid defense meetings and kept up with drug development trends. -
Clinical Project ManagerSyneos Health (Previously Inc Research/Inventiv Health) Feb 2016 - Apr 2019Morrisville, Nc, Us• Managed clinical trials across various phases and functional areas.• Ensured successful execution of all assigned projects, meeting quality and compliance standards.• Played a role in proposal development and bid defense.• Acted as the primary liaison with customers, vendors, and Investigator Sites.• Had line management responsibility for clinical staff.• Managed projects of varying complexity, from single service studies to global initiatives.
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Clinical Project ManagerParexel Sep 2014 - Feb 2016Durham, North Carolina, Us• Provided leadership for clinical trials and project teams, delivering projects on time, within budget, and with the highest quality.• Liaised with sponsors, assessed and initiated projects, managed resources, and led cross-functional teams.• Maintained compliance with SOPs, ICH-GCP, and local regulations.• Produced project progress reports and managed communication between the project team, Sponsor, and financial management. -
Assoc Clinical Project ManagerQuintiles Oct 2012 - Sep 2014Durham, North Carolina, Us• Assisted in executing regionally based clinical studies per contract.• Supported all clinical study-related activities for assigned projects, ensuring quality and timeline metrics.• Tracked and reported on project timelines.• Assisted clinical project managers with budget allocation and invoice approval.• Served as the primary backup project contact with Sponsor and internal project team.• Identified out-of-scope work and escalated findings to appropriate parties.• Coordinated data gathering for proposals.• Undertook clinical project management activities and trained junior project support staff. -
Clinical Project Support SpecialistQuintiles Sep 2011 - Oct 2012Durham, North Carolina, Us• Established and maintained project documentation and reviewed files for accuracy and completeness.• Coordinated and tracked project information, communications, and materials.• Updated internal systems, databases, and timelines with project-specific data.• Identified discrepancies in project tracking data and financial figures.• Distributed status, tracking, and project finance reports and prepared presentation materials.• Coordinated project team and customer meetings, including logistics.• Served as the primary backup contact for internal project teams and external stakeholders.• Undertook project management activities and mentored junior support staff.
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Clinical Research AssociateQuintiles Jul 2009 - Sep 2011Durham, North Carolina, Us• Completed therapeutic, protocol, and clinical research training.• Collected, tracked, and reviewed study site critical documents.• Documented all communication with study site personnel and clients.• Coordinated site recruitment and enrollment efforts.• Ensured data collection, tracked clinical data, and resolved data queries.• Evaluated and assured data quality and handled adverse events.• Adhered to ICH-GCP procedures.• Monitored site and subject progress, conducted on-site and remote monitoring.
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Clinical Field Manager/Clinical Research CoordinatorCtmg Inc. Jan 2008 - Jul 2009• Trained and mentored clinical personnel on trial protocols and standard operating procedures.• Managed the execution of clinical trials in physician offices.• Addressed clinical quality assurance issues in management meetings.• Created and maintained patient source documents.• Resolved clinical-related personnel matters and implemented corrective and preventive action solutions.• Provided management oversight to clinical personnel.• Executed clinical trials in physician offices.• Conducted prescreening, recruitment, screening, and consenting of patients.• Conducted patient study visits, including data collection, phlebotomy, and lab specimen preparation.• Documented and reviewed lab data and adverse events.• Maintained Investigational drug accountability and adhered to ICH-GCP procedures.• Reviewed protocols and ensured patient safety.• Assisted with clinical trial infrastructure duties.
Gaston Lopez Skills
Gaston Lopez Education Details
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Campbell UniversityClinical Research
Frequently Asked Questions about Gaston Lopez
What company does Gaston Lopez work for?
Gaston Lopez works for Takeda
What is Gaston Lopez's role at the current company?
Gaston Lopez's current role is Senior Clinical Operations Manager.
What is Gaston Lopez's email address?
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What is Gaston Lopez's direct phone number?
Gaston Lopez's direct phone number is +191973*****
What schools did Gaston Lopez attend?
Gaston Lopez attended Campbell University.
What skills is Gaston Lopez known for?
Gaston Lopez has skills like Clinical Trials, Ich Gcp, Cro, Electronic Data Capture, Clinical Data Management, Clinical Research, Ctms, Regulatory Affairs, Clinical Trial Management System, Good Clinical Practice, Cro Management, Clinical Monitoring.
Who are Gaston Lopez's colleagues?
Gaston Lopez's colleagues are Baptiste Corso, Candice Tam, Alexis Ricks, Kevin Baker, Tomáš Butko, Heath Heath Magnon, Nancy Wei Ong.
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