- Learning new cooking techniques and expanding my culinary skills
- Serve God and the community by offering time and support to shelters for the homeless, and women facing challenges
- Enjoy participating in exercising for overall physical and mental well-being
- Spending time with my husband and daughter
Lania Quaccoo Collins
Upper Marlboro
Summary
Highly motivated and detail-oriented professional with a proven track record of successfully overseeing complex projects and leading cross-functional teams. Possesses deep understanding of clinical trial processes and regulatory requirements, coupled with exceptional skills in project planning and stakeholder communication. Committed to driving successful project outcomes and actively contributing to advancement of clinical research.
Overview
17
17
years of professional experience
2
2
Certification
Work History
Clinical Study Project Manager
Beckman Coulter
04.2023 - Current
- Led cross-functional teams to successfully complete complex clinical trials for both Pre-market studies (pilot and pivotal stages) and Post market studies, within budget and deadline constraints.
- Managed clinical trials in Real-World Evidence, Immunology, hematology, In Vitro Diagnostics, and infectious diseases.
- Managed vendor relationships and negotiated contracts, ensuring timely delivery of high-quality services while maintaining cost control.
- Established effective communication channels among team members, fostering a collaborative environment conducive to successful project execution.
- Evaluated performance metrics against established benchmarks, identifying opportunities for improvement and implementing appropriate action plans.
- Streamlined clinical trial processes by implementing standardized project management methodologies, resulting in improved efficiency and reduced timelines.
- Built strong relationships with key opinion leaders in therapeutic areas relevant to company''s product pipeline, leveraging their expertise to inform study design decisions.
- Led efforts to optimize study site performance by implementing targeted monitoring strategies and providing ongoing support to site staff.
- Oversaw site selection and initiated partnerships with qualified investigators, leading to optimized resource utilization and accelerated study start-up times.
- Implemented data-driven decision-making processes for continuous process improvement in the conduct of clinical trials.
- Ensured compliance with regulatory requirements by conducting regular audits and implementing corrective actions as needed.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- 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.
- Coordinated with site investigators to ensure smooth execution of clinical trial protocols, addressing any challenges or concerns promptly.
- Conducted risk assessments for clinical trials, identifying potential issues and developing mitigation strategies to minimize impact on study timelines and outcomes.
- Managed vendor relationships to ensure timely delivery of services and cost-effective solutions for clinical trial needs.
- Reduced study timelines by effectively managing cross-functional teams, ensuring proper communication and resource allocation.
- Collaborated with regulatory affairs teams to ensure compliance with FDA guidelines and other applicable regulations throughout the study life cycle.
Clinical Project Manager
Becton, Dickinson, and Company
04.2021 - 04.2023
- Serves as the project lead for studies of moderate to high complexity from protocol development through study conduct and closeout in compliance with Good Clinical Practices, and all Global, National, and Local Regulations
- Develop the following reports: Risk Assessment Report, Project Status Report, Clinical Study Report, Time Tracker Report
- Reports to and collaborates with Clinical Portfolio Management to review business requests and evaluate or develop early plans and concepts for optimal study execution
- Negotiated vendor contracts with a focus on balancing cost-effectiveness with quality
- Prepares and reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters)
- Oversees/leads study-specific study management resources
- Develops and manages a group of studies for an entire business unit or large development program
- Provides critical thinking and leadership when issues arise during the execution of clinical studies
- Leads or contributes to continuous improvement activities/initiatives
- Manages relationships with sites/PIs and other study-related vendors, including CROs
- Creates aggressive but achievable resource and budget forecasts and timelines
- Interacts with Internal and External contacts, providing direction to the GCA cross-functional team members and vendors (if applicable) regarding the technical, protocol-specific, and operational aspects of assigned studies
- Established a culture of excellence within the team, leading by example and fostering an environment where high-quality work was consistently delivered.
- Achieved timely completion of all assigned clinical projects while remaining within budget constraints.
- Mentored junior team members through skill development workshops and one-on-one coaching sessions to enhance their abilities in managing complex projects successfully.
- Oversaw contract negotiation and vendor selection for clinical projects, securing cost-effective solutions without compromising quality or timelines.
- Facilitated strong relationships between study sites, sponsors, and internal teams through regular updates and effective communication strategies.
- Reduced project timelines for successful clinical trials by effectively managing resources and maintaining clear communication with stakeholders.
- Streamlined data management processes for efficient analysis and reporting of results from clinical studies.
- Developed strong partnerships with key stakeholders to facilitate smooth handovers during project transitions.
- Monitored unit budget to meet financial objectives for spend rate and funding.
Quality Assurance Specialist
University of Maryland, St Joseph
11.2019 - 06.2021
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Performed risk assessments on potential new projects, helping management make informed decisions about resource allocation and priorities.
- Maintained knowledge of industry best practices and evolving technologies, staying ahead of emerging quality assurance trends.
- Mitigated risks associated with product non-compliance, conducting rigorous quality control assessments.
- Fostered culture of continuous improvement, organizing training sessions on latest quality assurance best practices.
- Documented and reported quality assurance outcomes, providing actionable insights for product development teams.
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
- Performed routine maintenance and calibration on testing equipment.
- Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.
- Pioneered and developed the St Joseph University of Maryland Quality Assurance program
- Led the compilation and assembly of submission-related documents in electronic and paper format and of varying complexities to health authorities
- Supported the facility with CAP and CLIA audits
- Review validation plans, technical results, quality control, projects, and maintenance results
- Performing internal and external Audits within the UMM system
- Work as a regulatory liaison between Wright staff, Point-of-Care Coordinator, Laboratory Managers, and Supervisors
- Identifying and resolving workflow and laboratory production issues.
- Ensuring that standards and safety regulations are observed.
- Review the regulatory checklist for the different laboratory departments (Lab General, Hematology, Chemistry, Microbiology, Immunology, Point of Care, Transfusion Medicine, Anatomy and Pathology, and Cytology).
- Optimized workflow efficiency by introducing automation tools into the QA process where appropriate.
- Created testing protocols to be used across product lines.
Quality Assurance Specialist
Sysmex Inostics
10.2018 - 11.2019
- Established Standard Operation Procedures work processes and style guides for the department
- Aligned project management practices with industry standards
- Performed internal audits as well as support external audits
- Led control room during regulatory and partner audits to ensure all requests were filled and submitted to auditors promptly
- Maintained effective communication with staff concerning safety
- Interpret regulations about the improvement of health care
- Adhere and ensure workers are also adhering to health insurance laws
- Worked closely with industry-leading vendors to establish testing methodologies for both raw materials and finished products
- Ensured product compliance with industry regulations by staying up-to-date on relevant standards and guidelines, implementing necessary changes to maintain conformance.
- Utilized root cause analysis techniques to identify underlying issues contributing to product defects or customer complaints.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Streamlined the documentation process, ensuring adherence to industry standards and regulatory requirements.
- Fostered culture of continuous improvement, organizing training sessions on latest quality assurance best practices.
- Documented and reported quality assurance outcomes, providing actionable insights for product development teams.
- Enhanced efficiency of QA department, introducing metrics-driven performance evaluations.
- Monitored testing procedures and verified performance of tests according to established item specifications and protocol.
- Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.
Clinical Laboratory Technologist Lead
Johns Hopkins Hospital
07.2016 - 10.2018
- Supervised the Hematology, Coagulation, rapid Microbiology test, Immunology, and Urinalysis department.
- Validated New Laboratory instrumentation, point-of-care kits and Laboratory Information System
- Coordinated with external vendors for supply purchases or service requests as necessary.
- Ensured compliance with regulatory standards by conducting regular audits and updating policies as needed.
- Conducted laboratory tests for accurate diagnosis of patient conditions.
- Collaborated with medical staff to provide comprehensive patient care.
- Prepared detailed reports to convey test findings to clinicians.
- Improved patient outcomes with accurate and timely laboratory services.
- Trained new staff on laboratory procedures, enhancing team competency.
- Developed training materials and conducted workshops to enhance staff knowledge in specific areas of expertise.
- Contributed to the continuous improvement initiatives within the department, promoting a culture of innovation and excellence.
- Managed inventory of laboratory supplies, reducing waste while maintaining adequate stock levels for smooth operations.
- Evaluated new technologies and methodologies for potential integration into existing lab processes, enhancing capabilities and services offered.
- Increased productivity by effectively scheduling staff shifts, balancing workloads, and assigning appropriate tasks based on individual strengths.
- Maintained documentation on tests performed in lab.
- Tracked collected specimens by initialing, dating, and noting times of collection.
- Inspected laboratory equipment to maintain good working condition for optimal results.
- Developed new protocols and improved existing laboratory processes.
- Kept abreast of current industry, scientific and regulatory developments and issues.
- Set and oversaw quality assurance guidelines for laboratory work.
- Prepared reagents and solutions following standard laboratory formulas and procedures.
- Participated in lab meetings and project presentations.
- Adhered to laboratory safety procedures to maintain compliance with quality control standards.
Clinical Laboratory Technologist III
Johns Hopkins Hospital
11.2007 - 07.2016
- Provided training and mentorship to junior staff members, fostering a culture of continuous learning and professional growth.
- Established a culture of excellence within the lab by setting high expectations for performance and fostering a commitment to ongoing professional development.
- Collaborated with physicians and other healthcare professionals to ensure appropriate test ordering and result interpretation.
- Contributed to the development of new testing methods, enhancing diagnostic capabilities within the clinical lab setting.
- Streamlined laboratory processes by optimizing workflows and reducing turnaround times for critical test results.
- Supported interdisciplinary care teams by providing expert consultation on complex cases requiring advanced diagnostics or specialized testing methods.
- Troubleshot complex equipment issues, ensuring minimal downtime and consistent performance of laboratory instruments.
- Conducted comprehensive diagnostic tests for a variety of medical conditions, aiding in proper diagnoses and treatment plans.
- Gathered laboratory samples, monitored fluids and read test results to make accurate care decisions.
- Provided technical guidance and training to laboratory staff.
- Developed and implemented standard operating procedures to verify quality control.
- Investigated and resolved issues related to laboratory processes and procedures.
- Collaborated with other healthcare professionals to develop new procedures and protocols.
- Recorded and interpreted laboratory results to present to senior colleagues.
- Prepared and validated buffers and in-house reagents, calibrators, and controls in advance of laboratory testing and analysis orders.
- Collected and studied blood samples to determine number of cells, morphology, blood group and blood type.
- Prepared reports to document laboratory results and findings.
- Operated highly specialized laboratory equipment to process specimens.
- Utilized expertise in microbiology, chemistry, and hematology to help with diagnosis of medical issues.
- Evaluated and interpreted laboratory results to determine diagnoses.
Education
Master of Science - Regulatory Affairs Science
Johns Hopkins University
Baltimore, MD08.2020
Bachelor of Science - Clinical Laboratory Science (Medical Technology)
Andrews University
Berrien Springs, MI08.2007
Bachelor of Science - Biology
Andrews University
Berrien Springs, MI07-2004
Skills
- Time management
- Communication skills
- Project planning
- Budget management
- Risk assessment
- Quality assurance
- Microsoft Office
- Milestone tracking
- Customer relations
- Presentations
- Performance improvements
Certification
- Project Management Professional (PMP)
- Certified Laboratory Scientist (CLS) - American Society for Clinical Pathology.
Accomplishments
- Led Clinical trial to success: Overcame enrollment challenges in a critical trial, meeting target goals, and recognized for exceptional leadership skills.
- Cost Reduction in Project Management: Understood project costs and identified areas for potential cost savings. Communicated financial implications and ultimately reached a mutually beneficial agreement with a30% saving cost.
- Innovative Dashboard Development: Create a pioneering project monitoring dashboard, dramatically improving client engagement and operational transparency.
- Developed Customer Services Skills: Built strong relationships and providing regular updates to the sites.
Interests
Timeline
Clinical Study Project Manager
Beckman Coulter
04.2023 - Current
Clinical Project Manager
Becton, Dickinson, and Company
04.2021 - 04.2023
Quality Assurance Specialist
University of Maryland, St Joseph
11.2019 - 06.2021
Quality Assurance Specialist
Sysmex Inostics
10.2018 - 11.2019
Clinical Laboratory Technologist Lead
Johns Hopkins Hospital
07.2016 - 10.2018
Clinical Laboratory Technologist III
Johns Hopkins Hospital
11.2007 - 07.2016
- Project Management Professional (PMP)
- Certified Laboratory Scientist (CLS) - American Society for Clinical Pathology.
Master of Science - Regulatory Affairs Science
Johns Hopkins University
Bachelor of Science - Clinical Laboratory Science (Medical Technology)
Andrews University
Bachelor of Science - Biology
Andrews University
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