Clinical Project Manager with 15+ years of experience in clinical operations & project management. Proficient in Microsoft Suite & health services, successfully delivering projects on time. Notable achievement: reduced operational costs by 20% while improving project outcomes.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Project Manager, Operational Strategy & Planning
Novo Nordisk/Kelly Service
06.2024 - 01.2025
Developed the project plan.
Developed & maintained the project schedule.
Held regular meetings with cross-functional project teams to monitor project progress.
Regularly updated internal stakeholders on high-level project status.
Advised the sponsor on managing organizational change.
Supplied consultation on the Lab Information Systems & Services.
Lead Change Management workshops/presentations to engage customer lab staff.
Managed & communicated project risks that impacted the project or organization.
Local teams engaged to create a sustainable product placement.
Participated in continuous improvement sessions to further professionalize the Projects Department.
QC’ed configurations before manufacturing requests.
Coordinated installs & application resources.
Interfaced with cross-functional groups to manage cross-functional processes & resolve issues impacting sponsors.
Improved team readiness & operational efficiency through developing & implementing new Learning Management System (LMS) courses for Clinical Trial Teams on products, SOPs, & role-based training.
Ensuring consistent, high-quality training delivery across teams through conducting facilitator training sessions to improve team effectiveness in delivering virtual presentations & optimizing the use of digital tools.
Collaborate with stakeholders to ensure alignment, address gaps, & ensure compliance with Standard Operating Procedures (SOPs), Good Practices (GxP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) & Good Clinical Practice (GCP) guidelines.
Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
Planned, designed, and scheduled phases for large projects.
Met project deadlines without sacrificing build quality or workplace safety.
Established effective communication among team members for enhanced collaboration and successful project completion.
Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
Delivered exceptional customer satisfaction by proactively addressing client concerns and meeting or exceeding expectations throughout the engagement process.
Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
Identified plans and resources required to meet project goals and objectives.
Developed strong relationships with stakeholders through regular communication updates, fostering trust and confidence in the team's ability to deliver results.
Collaborated closely with senior management to align project objectives with strategic company initiatives, ensuring that efforts contributed to overall business growth.
Coordinated with cross-functional teams to resolve project issues and mitigate risks.
Monitored project performance to identify areas of improvement and make adjustments.
Coordinated cross-functional teams and resolved conflicts, maintaining a positive work environment throughout the project lifecycle.
Provided detailed project status updates to stakeholders and executive management.
Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
Managed projects from procurement to commission.
Provided detailed technical and operational direction in project challenges, consistently meeting deliverables according to deadlines.
Prepared detailed reports on project status for stakeholders, ensuring transparency and alignment with objectives.
Coordinated material procurement and required services for projects within budget requirements.
Negotiated contracts with vendors and suppliers, securing quality materials at competitive prices for efficient use of resources.
Negotiated and managed third-party contracts related to project deliverables.
Created accurate budgets based on resource requirements, allowing for optimal allocation of funds across all aspects of the projects.
Effectively managed scope creep by establishing clear boundaries on requested changes while keeping projects aligned with original objectives and budgets.
Implemented continuous improvement initiatives to optimize project outcomes while maintaining cost-effectiveness.
Mentored junior team members in project management best practices to enhance their skills and contribute to better overall performance.
Enhanced overall project success by conducting thorough post-project evaluations and incorporating lessons learned into future efforts.
Fostered a culture of innovation and creativity within the project team, leading to improved problem-solving capabilities and enhanced outcomes.
Proved successful working within tight deadlines and a fast-paced environment.
Completed projects within tight deadlines, coordinating team efforts, and prioritizing tasks effectively.
Achieved high levels of team engagement and morale by promoting a collaborative and inclusive work environment.
Facilitated smoother project transitions, ensuring thorough documentation and effective handovers.
Ensured projects aligned with strategic objectives, working closely with senior management to refine project goals.
Enhanced team performance with targeted training programs, addressing skill gaps, and promoting professional development.
Promoted innovation within project teams, encouraging exploration of new tools and methodologies to enhance project outcomes.
Led cross-functional teams to successful project completions, improving team cohesion and productivity with effective leadership strategies.
Streamlined procurement process for project materials, reducing wait times and avoiding potential delays.
Streamlined project initiation processes, enabling quicker transition from planning to execution.
Maintained compliance with industry standards and regulations, conducting regular audits and updates to project practices.
Oversaw implementation of new project management software, facilitating more efficient workflow and better project tracking.
Enhanced project delivery times by streamlining communication channels between development and operations teams.
Reduced project costs, negotiating contracts with suppliers, and optimizing resource allocation.
Optimized project schedules, identifying critical path tasks, and reallocating resources to maintain momentum.
Enhanced project visibility, implementing a dashboard and reporting tools for real-time progress monitoring.
Improved client relationships, consistently meeting or exceeding project expectations, and maintaining open lines of communication.
Developed comprehensive risk management plans, minimizing project delays and unexpected challenges.
Fostered a culture of continuous improvement, conducting post-project reviews to identify lessons learned and best practices.
Improved stakeholder satisfaction with detailed project updates and proactive issue resolution.
Monitored project progress, identified risks, and took corrective action as needed.
Achieved significant improvements in project quality by establishing rigorous quality control processes.
Tracked project and team member performance closely to quickly intervene in mistakes or delays.
Maintained open communication by presenting regular updates on project status to customers.
Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules, and conflicts.
Reported regularly to managers on project budget, progress, and technical problems.
Developed and implemented project plans and budgets to ensure successful execution.
Sourced, vetted, and managed vendors needed to accomplish project goals.
Analyzed project performance data to identify areas of improvement.
Recruited and oversaw personnel to achieve performance and quality targets.
Verified the quality of deliverables and conformance to specifications before submitting to clients.
Facilitated workshops to collect project requirements and user feedback.
Clinical Project Manager - Neurology - CNS
Worldwide Clinical Trials
08.2022 - 01.2024
Point of Contact (POC) for cross-functional teams, leadership, & clients.
Executed the implementation of managed projects & protocols with ClinSpark, Vendor oversight for adherence to budget, timelines & organizational objectives of protocols/programs.
Supported financial management of the study, which included review & approval of site & vendor invoices per contract terms.
Developed strong vendor & site relationships to ensure consistency of relationships through all phases of the trial.
Managed & coached cross-functional team, conducted QA reviews, maintained coverage, & readiness across all communication channels to ensure completion of milestones.
Created & Executed SOPs, coaching programs, & QC’ed documentation quality.
Maintained & routed formal project documentation to project teams & key stakeholders promptly.
Performed reviews to monitor project progress with established success measures, including date accuracy, KPIs, revenue forecasting, & objectives.
Collaborate with stakeholders to ensure alignment, address gaps, & ensure compliance with Standard Operating Procedures (SOPs), Good Practices (GxP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) & Good Clinical Practice (GCP) guidelines.
Facilitated meetings with business process owners to identify project goals, objectives, & critical success factors.
Performed reviews of eTMF/TMF to ensure adherence to standards & compliance.
Maintain clinical trial registry entries/updates, as required.
Managed resources & assigned responsibilities.
Generated regular reports on clinical trial progress using ClinSpark, providing timely updates to stakeholders.
Enhanced patient safety during clinical trials with rigorous monitoring and strict adherence to protocols.
Achieved timely completion of all assigned clinical projects while remaining within budget constraints.
Developed strong partnerships with key stakeholders to facilitate smooth handovers during project transitions.
Coordinated site visits and audits for ongoing quality assurance during all phases of the clinical trial process.
Reduced project timelines for successful clinical trials by effectively managing resources and maintaining clear communication with stakeholders.
Improved clinical trial efficiency by streamlining project management processes and implementing best practices.
Established a culture of excellence within the team, leading by example and fostering an environment where high-quality work was consistently delivered.
Conducted thorough risk assessments for each project, proactively mitigating potential issues before they escalated.
Mentored junior team members through skill development workshops and one-on-one coaching sessions to enhance their abilities in managing complex projects successfully.
Developed comprehensive training programs for new hires, ensuring a high level of competency within the team.
Collaborated closely with medical experts, investigators, and external partners to ensure accurate data collection in line with research objectives.
Implemented innovative strategies to improve patient recruitment and retention rates in clinical studies.
Oversaw contract negotiation and vendor selection for clinical projects, securing cost-effective solutions without compromising quality or timelines.
Optimized resource allocation across multiple concurrent projects by utilizing advanced scheduling tools.
Championed continuous improvement initiatives resulting in increased efficiency and cost savings for clinical projects.
Facilitated strong relationships between study sites, sponsors, and internal teams through regular updates and effective communication strategies.
Communicated effectively with staff members, physicians, and patients, employing active listening and interpersonal skills.
Managed cross-functional teams, resulting in seamless collaboration and increased productivity in clinical projects.
Streamlined data management processes for efficient analysis and reporting of results from clinical studies.
Regularly evaluated employee performance and provided feedback.
Delegated tasks to staff members, monitored completion of all duties and provided support to enhance performance.
Promoted high morale and staff retention through dynamic communication, prompt problem resolution, proactive supervisory practices and facilitation of positive work environment.
Identified opportunities to improve clinical practices, devised strategies and implemented plans to increase patient care standards and enhance operational procedures.
Managed [Number] employees with various personalities and from different cultures for large [Number]-physician practice.
Oversaw overall operation of nursing services and patient care.
Delivered effective onboarding and training to new and existing employees and cross-trained staff members in other job roles to maximize coverage.
Worked with nurse manager to develop nursing staff through education, evaluation, performance management, and competency improvement.
Implemented onboarding for new employees, which enabled each to effectively learn tasks and job duties.
Implemented new policies and educated staff on changes.
Handled job duties for staff members which were unavailable or out of office.
Communicated with patients, asked appropriate questions, and employed active listening to determine best care.
Provide ongoing case management to patients to implement appropriate treatment plan, adhere to quality models and maximize utilization of services needed to achieve optimal outcomes.
Reviewed operational policies and recommended solutions and change to medical director.
Selected, promoted and terminated staff members.
Clinical Project Manager I - COE
LabCorp
12.2020 - 08.2029
Point of Contact (POC) for cross-functional teams, leadership, & clients.
Contributed to the development of study protocols using ClinSpark, ensuring alignment with GCP guidelines and IRB requirements.
Managed & coached cross-functional team, conducted QA reviews, maintained coverage, & readiness across all communication channels to ensure timely completion of milestones & delivery of quality work.
Created & Executed SOPs, coaching programs, & QC’ed documentation quality.
Maintained & routed formal project documentation to project teams & key stakeholders promptly.
Regularly monitored project progress & ensured alignment with established success measures with date accuracy, creating KPIs, revenue forecasting, & objectives.
Collaborate with stakeholders to ensure alignment, address gaps, & ensure compliance with Standard Operating Procedures (SOPs), Good Practices (GxP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) & Good Clinical Practice (GCP) guidelines.
Conducted thorough requirements analysis, collaborating with stakeholders to gather and document functional and non-functional requirements.
Prepared for & participated in third-party audits/FDA inspections.
Managed resources & assigned responsibilities, ensuring all team members had the support & tools they needed.Coordinated with TMF management & TMF reviews for trials as needed.
Clinical Project Manager II - RWE & HEOR
AbbVie/Collaborative LLC
10.2019 - 07.2020
Oversaw clinical trial data management & vendor relationships for new & existing pharmaceutical products, partnering with Health Economics & Outcomes Research (HEOR) & Real-World Evidence (RWE) teams.
Executed needs assessments to align project deliverables with organizational objectives.
Scheduled & led weekly Scientific meetings with subject-matter experts, capturing key discussion points & action items.
Delivering progress updates to leadership & coordinating cross-functional teams to ensure protocol compliance, risk management, & budget oversight.
Managed vendor contracts, including Statements of Work (SOWs) & amendments, processed invoices, & tracked trial milestones & expenditures.
Collaborated closely with project managers & external CROs to oversee studies across multiple countries.
Project Manager I / Business Analysis – Learning & Development
Abbott Laboratories/TekSystems
06.2018 - 10.2019
Led the development & implementation of management training courses for internal departments.
Facilitated weekly meetings with teams across LATAM, APAC, the US, & EU, providing leadership updates on course progress & necessary adjustments.
Served as primary point of contact on the sponsor side, charged with managing multiple clinical trials across various therapeutic areas, including Oncology, Cardiology, Immunology, & Infectious Diseases.
Collaborated closely with project managers & external CROs to oversee studies.
Prior Work Experience
01.1998 - 01.2016
Administrative Assistant, Contract Marketing, Pricing, Sales & Project Specialist roles with Abbott Laboratories/Hospira, Takeda/TAP Pharmaceuticals, as well as Training, Document Specialist with Mitsubishi Electric Automation & Manager/Supervisor with Miracle Group.
Education
Bachelor of Science - Business Management
Everest University
Bradon, FL
12.2014
Bachelor of Science - Healthcare Compliance & Regulation
Project Management Professional (PMP) Certification
Coursera & Google offer a comprehensive course covering essential project management skills.
Awards
Implemented Major Clinical Project Manager, Led a major clinical project that improved patient outcomes., Reduced Operational Costs, Achieved a 30% reduction in operational costs while improving project outcomes., Enhanced Project Efficiency, Coordinated cross-functional teams, increasing project efficiency., Improved Patient Care Quality, Oversaw clinical operations, resulting in a 15% improvement in patient care quality.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Project Manager, Operational Strategy & Planning
Novo Nordisk/Kelly Service
06.2024 - 01.2025
Clinical Project Manager - Neurology - CNS
Worldwide Clinical Trials
08.2022 - 01.2024
Clinical Project Manager I - COE
LabCorp
12.2020 - 08.2029
Clinical Project Manager II - RWE & HEOR
AbbVie/Collaborative LLC
10.2019 - 07.2020
Project Manager I / Business Analysis – Learning & Development