Accomplished leader with expertise in team management and performance monitoring. Implemented training programs and process enhancements that significantly improved workflow efficiency and compliance in clinical operations.
Overview
2027
2027
years of professional experience
Work History
Study Delivery Lead
Daiichi Sankyo Inc.
Basking Ridge, New Jersey
07.2025 - Current
Managed team communications to streamline workflow and enhance operational efficiency.
Trained new team members on safety protocols and delivery procedures.
Collaborated with cross-functional teams to resolve delivery issues.
Monitored team performance and provided constructive feedback regularly.
Conducted regular team meetings to discuss performance and address challenges encountered.
Monitored performance metrics to pinpoint specific areas for targeted improvement.
Fostered a collaborative team environment to enhance overall productivity.
Facilitated execution roadmaps to support continuous improvement and foster knowledge sharing and collaboration among team members.
Coached professional development opportunities for team members with career development plans.
Designed budgets for delivery departments and planned financial outlines.
Study Team Lead
Daiichi Sankyo Inc.
Basking Ridge, New Jersey
2021 - 2025
Led cross-functional teams to enhance project delivery timelines.
Coordinated with stakeholders to align project goals with business objectives.
Facilitated regular team meetings to ensure open communication and collaboration.
Mentored junior staff, providing guidance on best practices and methodologies.
Managed resource allocation to support project needs and team dynamics.
Delivery Lead, Sr Clinical Study Manager
Daiichi Sankyo Inc.
Edison, New Jersey
11.2016 - 03.2021
Managed clinical study operations to ensure compliance with regulatory guidelines.
Coordinated cross-functional teams for successful study execution and collaboration.
Developed study protocols and maintained project timelines effectively.
Reviewed study documents for quality assurance and adherence to company standards.
Liaised with external vendors to support clinical trial activities and procurement needs.
Collaborated with external vendors such as laboratories, CROs, imaging centers to facilitate successful completion of the trial activities.
Created detailed case report forms based on protocols specifications.
Managed operational aspects of clinical studies including budgeting, forecasting and tracking expenses.
Coordinated laboratory activities related to sample collection and shipment according to protocol requirements.
Expert Clinical Manager
Aerotek for Novartis
East Hanover, New Jersey
06.2015 - 06.2016
Oversaw clinical trial protocols, ensuring compliance with regulatory standards to uphold trial integrity.
Monitored data collection processes, ensuring integrity and accuracy of information for reliable trial outcomes.
Implemented quality control measures to ensure adherence to trial protocols.
Created training materials for staff on clinical procedures and best practices to enhance team knowledge and performance.
Facilitated meetings to discuss project updates and address team concerns.
Participated in meetings with other healthcare professionals to discuss best practices.
Managed patient care and clinic services and handled financial management, quality assurance and safety and risk management.
Clinical Project Manager
Pfizer, Inc
New York, New York
04.2007 - 01.2013
Led cross-functional teams to meet project timelines and deliverables.
Developed and managed project plans using industry-standard tools and methodologies.
Coordinated clinical trial activities in compliance with regulatory guidelines.
Facilitated stakeholder communication to align project objectives and expectations.
Monitored project progress and identified risks to maintain timelines and outcomes.
Mentored junior team members on best practices in clinical project management.
Reviewed study protocols for clarity and adherence to scientific standards.
Implemented process improvements that streamlined operational efficiency in clinical trials.
Business Support Manager, Quality Managagement
Pfizer, Inc.
New York, New York
04.2003 - 10.2006
Oversaw budget management for departmental initiatives to optimize resource allocation.
Implemented process improvements to enhance workflow efficiency across multiple teams.
Prepared reports on project status and key performance indicators for leadership review.
Supported compliance efforts by maintaining accurate records and documentation procedures.
Developed procedural manuals for operational areas within scope of business support responsibilities.
Created reports and presentations for senior management to highlight departmental performance metrics.
Prepared and presented business reports to senior management and stakeholders to inform strategic decisions.
Utilized data analytics to inform decision-making and identify areas for improvement.
Developed training materials to streamline staff onboarding and improve operational efficiency.
Manager, Quality Standards
Pfizer, Inc.
New York, New York
01.2001 - 04.2003
Managed project timelines and resources for multiple pharmaceutical initiatives, ensuring timely delivery and regulatory compliance.
Oversaw budgeting processes to align financial resources with strategic organizational objectives.
Developed training programs enhancing team capabilities and understanding of industry regulations.
Coached and mentored team members, improving overall job performance and skill sets.
Fostered stakeholder relationships to drive collaboration and project alignment.
Created monthly reports for senior management summarizing operational performance metrics.
Data Manager, Team Lead
SmithKline Beecham Pharmaceuticals
Collegeville, Pennsylvania
1995 - 1997
Managed data integrity across multiple pharmaceutical databases and systems.
Developed strategies for optimizing data collection and storage processes.
Trained staff on best practices for data entry and maintenance.
Analyzed trends in clinical data to support research initiatives.
Implemented data quality checks to enhance accuracy and reliability.
Data Manager
SmithKline French
Philadelphia, Pennsylvania
1988 - 1995
Managed data collection processes for clinical trial studies.
Oversaw data integrity and compliance with regulatory standards.
Collaborated with cross-functional teams to streamline data workflows.
Trained staff on data entry systems and database management tools.
Implemented processes to ensure accuracy of data across multiple databases.
Study Manager
Pfizer, Inc.
New York, New York
10.2006 - 2007
Developed comprehensive study plans and maintained meticulous documentation for regulatory submissions.
Managed study timelines, ensuring strict compliance with protocols and regulations.
Monitored clinical study progress, resolving issues promptly to ensure schedule adherence.
Oversaw site selection and vendor management to optimize clinical study execution.
Tracked milestones of clinical studies to ensure adherence to established protocols.
Coordinated clinical trial activities, streamlining data collection and analysis processes.
Drafted informed consent forms per FDA standards for participant enrollment in trials.
Compiled data for entry into relevant databases, maintaining accuracy.
Education
Bachelor of Science - Business Management
University of Phoenix
Tempe, AZ
03-2008
Some College (No Degree) - Psychobiology
Albright College
Reading, PA
Skills
Clinical oversight
Regulatory compliance
Requirements gathering
Performance monitoring
Budget planning
Reporting tools
Continuous improvement
Problem resolution
Stakeholder management
Cross-functional collaboration
Team management
Training development
Data integrity monitoring
Computer skills
Constructive feedback
Problem-solving
Accomplishments
Developed, Rolled out and Implemented the Quality Deliverables System 2003