Ashley Horstmeier
Layton,UT
Overview
6
6
years of professional experience
1
1
Certification
Work History
Technology Transfer Project Manager II
BioMerieux
04.2023 - Current
- Manages and oversees multiple projects concurrently, ranging from medium to high complexity, often comprising sub-projects.
- Coordinates cross-functional activities meticulously to ensure project completion within regulatory, scope, and schedule constraints.
- Serves as internal consultant for assessing and addressing project requirements, leveraging expertise to optimize project outcomes.
- Leads and directs execution of project implementation strategies with precision and attention to detail.
- Analyzes and assesses scope and impact of new products, processes, and proposed changes, offering valuable insights and recommendations.
- Participates in review and resolution process of Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs), ensuring adherence to quality standards.
- Collaborates with management in design and implementation of comprehensive training programs to enhance team proficiency and performance.
- Mentors and coaches Technology Transfer Project Coordinators and Managers, fostering professional development and growth within team.
- Conducts ongoing research to stay abreast of current best practices in both Transfer and project management, driving continuous improvement initiatives.
- Monitors progress against established goals, adjusting schedules and resources as needed to keep projects on track.
- Maintains open communication by presenting regular updates on project status to stakeholders.
- Provides 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.
Technology Transfer Project Manager I
BioMerieux
09.2021 - 04.2023
- Directed departmental projects by initiating and maintaining comprehensive project plans, updating timelines, and managing resource allocation to ensure optimal project execution.
- Collaborated with project steering committees to uphold alignment with organizational objectives and project scope, fostering seamless coordination among team members and stakeholders for successful project delivery and closure.
- Authored specifications, validation plans, protocols, and reports essential for validation and qualification of project management processes, in close collaboration across departments and leadership.
- Facilitated compilation and effective communication of observations, data, and conclusions, leveraging collaborative efforts with program management and project management teams to drive informed decision-making and actionable insights.
- Embed quality system regulation and regulatory compliance measures across all project initiatives to ensure adherence to industry standards and regulatory requirements, safeguarding project integrity and outcomes.
- Pioneered investigations, experiments, and advancements in methodologies and technologies to propel project progression and innovation, driving continuous improvement and strategic evolution.
- Applied professional concepts, best practices, and innovative problem-solving strategies to navigate complex challenges, creatively and efficiently achieving organizational objectives and fostering sustainable solutions.
- Maintained open communication by presenting regular updates on project status to stakeholders.
- Developed strong relationships with stakeholders through regular communication updates, fostering trust and confidence in team's ability to deliver results.
- Provided detailed project status updates to stakeholders and executive management.
- Coordinated cross-functional teams and resolved conflicts, maintaining positive work environment throughout project lifecycle.
- Monitored project performance to identify areas of improvement and make adjustments.
Project Administrator
Huntsman Cancer Institute
03.2020 - 09.2021
- Supported Principal Investigators and study staff in all aspects of clinical trial operations.
- Ensured high-quality source documents and data to sponsors, while maintaining protocol compliance within regulatory guidelines and standards, thereby fostering trust and credibility in trial outcomes.
- Proactively monitored and upheld compliance with eligibility criteria, protocol requirements, and data submission deadlines.
- Identified and resolved monitoring/auditing reports providing effective direction and oversight to maintain operational efficiency and regulatory adherence.
- Provided comprehensive personnel management and supervision, offered mentorship and training to research staff, and developed robust team coverage plans to ensure seamless operations.
- Contributed to development of educational materials on coordination and data completion processes, along with evaluation and education tools to assess staff competency, fostering culture of continuous learning and improvement.
- Lead study start-up activities, oversaw workload resourcing for team, and served as point of contact for initiating key activities such as Confidential Disclosure Agreements (CDAs) and feasibility assessments
- Developed, implemented, and enforced Standard Operating Procedures (SOPs) and Work Practice Documents to standardize processes and ensure consistency in operations.
- Oversaw accurate and timely reporting of Adverse Events (AE) and Serious Adverse Events (SAE), as well as deviations, to sponsors and Institutional Review Board (IRB), maintaining transparency and compliance with regulatory requirements.
- Manage workflow efficiency by conducting periodic performance and salary reviews, and revising operating procedures as needed to optimize team performance and meet organizational objectives.
- Assumed responsibility for additional assignments as directed by Program Manager, demonstrating flexibility and adaptability in addressing evolving needs and priorities.
- Collaborated with management and fellow supervisors to organize operations and achieve demanding schedule targets.
- Delegated assignments based on plans, project needs, and knowledge of individual team members.
Clinical Research Coordinator
Huntsman Cancer Institute
01.2019 - 03.2020
- Oversaw compliance to protocol; managed quality control, completion, and submission of study-related documentation; prepared reports for organizations and agencies.
- Monitored enrollment goals and initiated strategies to promote enrollment and participant compliance. Coordinated and performed responsibilities related to research participants, including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits, and acting as liaison between participants and study-related parties.
- Recognized, tracked, and reported adverse events and protocol deviations.
- Prepared for and coordinated site visits made by sponsors or federal agencies during study duration and study closure.
- Represented research program at meetings, national, and international research consortia.
- Prepared, submitted, and maintained IRB, FDA, NCI, NIH, NSF, and other regulatory documents and research correspondence.
- Contributed to developing educational materials and educated community and other research professionals regarding studies and related research issues.
- Supervised, mentored, and trained new or junior research staff.
- Coordinated with referring physicians to provide information regarding available research projects and to maintain strong referral basis.
- Developed and maintained patient databases, investigational logs, and records of drugs administered, medical devices monitored, and/or procedures followed.
- Assisted Principal Investigators in development of study protocols.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Contributed to successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Research Data Coordinator
Huntsman Cancer Institute
03.2018 - 01.2019
- Established strong relationships with external partners, facilitating seamless collaboration on joint research projects when necessary.
- Assisted in development of user-friendly databases for efficient storage and retrieval of research data.
- Enhanced data accuracy by implementing stringent quality control measures and cross-checking procedures.
- Provided input in design of protocols, forms, and data collection processes to optimize study efficiency and effectiveness.
- Created and maintained study-specific documents, ensuring accuracy, completeness, and compliance with regulatory requirements.
- Ensured timely provision of documents according to established timelines and Standard Operating Procedures (SOPs), maintaining organizational efficiency and adherence to protocol.
- Managed all data management activities of clinical trial projects, including data collection, entry, cleaning, and analysis, to ensure data integrity and accuracy.
- Communicated issues affecting timeline, deliverables, and data quality to study team and functional supervisor, facilitating proactive resolution and mitigation of risks.
- Interacted frequently with study team members to troubleshoot, manage, and develop study-specific processes, fostering collaboration and continuous improvement.
- Complied with market research best practices and appropriate ISO guidelines.
- Ensured data integrity, adhering to strict confidentiality protocols and regulatory guidelines.
- Provided timely support to researchers by addressing their data-related queries and concerns.
Education
MBA - Business Administration
Western Governors University
Salt Lake City, UT02.2024
Bachelor of Science - Health Education And Promotion
Boise State University
Boise, ID12.2014
Skills
- Project Management
- Technical writing
- Cross Functional Collaboration
- Meeting facilitation
- Servant Leadership
- Project Scope
- Functional & Business Requirements
- Change Control Processes
- Advanced problem solving
- Team Collaboration
- Processes and procedures
- Coaching and Mentoring
Certification
- PMP - Project Management Professional
- Certificate of Technical Writing in Change Control Documents and Standard Operating Procedures
Timeline
Technology Transfer Project Manager II
BioMerieux
04.2023 - Current
Technology Transfer Project Manager I
BioMerieux
09.2021 - 04.2023
Project Administrator
Huntsman Cancer Institute
03.2020 - 09.2021
Clinical Research Coordinator
Huntsman Cancer Institute
01.2019 - 03.2020
Research Data Coordinator
Huntsman Cancer Institute
03.2018 - 01.2019
MBA - Business Administration
Western Governors University
Bachelor of Science - Health Education And Promotion
Boise State University
- PMP - Project Management Professional
- Certificate of Technical Writing in Change Control Documents and Standard Operating Procedures