Beth Minich Stack Email & Phone Number

Allentown, Pa, Us

Collegeville, Pennsylvania, United States

• Functioned as the Enrollment Modeling Group Lead for various therapeutic areas, including Vaccines, Inflammation / Immunology, and Internal Medicine.• Executed as a leader in the development, implementation, and ongoing refinement of enrollment planning processes and tools across various functional lines within Pfizer.• Served as a mentor and point of issue escalation within the Enrollment Planning team.• Leveraged historical enrollment data across various indications to influence… Show more • Functioned as the Enrollment Modeling Group Lead for various therapeutic areas, including Vaccines, Inflammation / Immunology, and Internal Medicine.• Executed as a leader in the development, implementation, and ongoing refinement of enrollment planning processes and tools across various functional lines within Pfizer.• Served as a mentor and point of issue escalation within the Enrollment Planning team.• Leveraged historical enrollment data across various indications to influence Pfizer and CRO study teams toward realistic, data-driven enrollment planning.• Developed enrollment scenarios to inform early program or study decision-making, providing recommendations to support the development of more consistent and accurate study enrollment projections.• Contributed to the development of enrollment monitoring processes to identify risks in ongoing studies. Monitored enrollment progress versus the study enrollment plans to proactively assess risks in meeting the targeted timelines, adjusting enrollment plans to accurately reflect current status.• Served as Study Optimizer (DVSO) enrollment planning application subject matter expert, instructed study teams and CROs on effective use of the application, including education on complex system algorithms, and problem-solved enrollment planning strategies for complex study designs.• Provided concepts, specifications, and expertise for several significant industry-wide Study Optimizer enhancements, including substantial advances in cohort planning and methodology for enrollment rate calculations. Collaborated with the application vendor to develop and test enhancements, coordinated application upgrades / fixes, and managed the vendor to resolve system issues / bugs.• Represented the department on cross-functional initiatives and task forces. Show less

Collegeville, Pa

Job description similar to above.

Collegeville, Pa

• Presented internal and external historical recruitment and start-up data to influence study teams toward more accurate enrollment planning.• Drove the implementation and adoption of Decision View Study Optimizer (DVSO) patient enrollment planning and tracking application and associated enrollment planning processes within Pfizer and the Alliance Partner CROs.• Served as Study Optimizer (DVSO) subject matter expert, including responsibilities noted in the Trial Optimization Lead /… Show more • Presented internal and external historical recruitment and start-up data to influence study teams toward more accurate enrollment planning.• Drove the implementation and adoption of Decision View Study Optimizer (DVSO) patient enrollment planning and tracking application and associated enrollment planning processes within Pfizer and the Alliance Partner CROs.• Served as Study Optimizer (DVSO) subject matter expert, including responsibilities noted in the Trial Optimization Lead / Performance Analyst description above.• Led the reconciliation of over 150 studies to ensure the appropriate trials were added or updated within the enrollment planning system.• Partnered with the Business Performance and Analytics group to standardize enrollment curves for reporting to senior leadership. Show less

Collegeville, Pa

• Provided expertise to study teams in conducting protocol feasibilities, historical data mining, scenario modeling, recruitment forecasting, and study timeline projections.• Authored the Protocol Operations Plan (POP) and other deliverables essential to the Development Operations brokerage.• Coordinated information sharing between Clinical Operations staff in Developed and Emerging countries, Regional Medical Monitors (RMMs), and CRO staff.• Developed and shared knowledge of… Show more • Provided expertise to study teams in conducting protocol feasibilities, historical data mining, scenario modeling, recruitment forecasting, and study timeline projections.• Authored the Protocol Operations Plan (POP) and other deliverables essential to the Development Operations brokerage.• Coordinated information sharing between Clinical Operations staff in Developed and Emerging countries, Regional Medical Monitors (RMMs), and CRO staff.• Developed and shared knowledge of country capabilities, disease incidence, standard of care, competitive landscape, historical performance, and country start-up times to drive study teams toward optimal country selection.• Ensured the timing and objectives of the feasibility process were well-communicated and understood by all stakeholders.• Successfully led and participated in several accelerated workstreams to implement the Decision View Study Optimizer (DVSO) patient enrollment planning and tracking application across the Pfizer portfolio.• Served as a subject matter expert (SME) for the Study Optimizer system and conducted company-wide training sessions.• Liaised with Study Optimizer vendor staff to provide recommendations on system improvements.• Nominated for the Pfizer Individual Performance Award for exceptional performance in leading DVSO workstreams and system implementation. Show less

Collegeville, Pa

• Spearheaded study execution and regulatory compliance / GCP adherence, timelines, and enrollment within the US.• Championed site qualification, identification, and selection input, maintained a strong knowledge of the medical and operational aspects of the trial, and served as a point of contact and escalation for sites and Site Managers (SMs).• Maintained knowledge of the clinical database and served as an escalation point for data issues.• Provided direct oversight of the CRO… Show more • Spearheaded study execution and regulatory compliance / GCP adherence, timelines, and enrollment within the US.• Championed site qualification, identification, and selection input, maintained a strong knowledge of the medical and operational aspects of the trial, and served as a point of contact and escalation for sites and Site Managers (SMs).• Maintained knowledge of the clinical database and served as an escalation point for data issues.• Provided direct oversight of the CRO and selected qualified CRO personnel based on review of CVs.• Coordinated and participated in the training of the CRO team members.• Assisted in the development of the Global Monitoring Plan and ensured proper execution.• Reviewed and approved site-specific informed consent forms (ICFs).• Analyzed trip reports and proactively identified and addressed issues.• Coordinated with Clinical Pharmacy to track and manage site drug supply.• Liaised with Legal and the Wyeth / Pfizer Contracting departments to drive investigator contract / budget negotiations. Managed and tracked site and vendor payments.• Administered follow-up and resolution of audit findings for the Oncology therapeutic area. Show less

Collegeville, Pennsylvania, United States

• Served as the Global Trial Manager for several clinical studies from the time a protocol synopsis was drafted until the database was frozen.• Managed, coordinated, and facilitated key trial activities globally in several regions including North America, Latin America, Europe, and Asia.• Participated in the selection and management of vendors including CRO and central independent reader.• Coordinated site selection and oversaw the site start-up process.• Tracked patient… Show more • Served as the Global Trial Manager for several clinical studies from the time a protocol synopsis was drafted until the database was frozen.• Managed, coordinated, and facilitated key trial activities globally in several regions including North America, Latin America, Europe, and Asia.• Participated in the selection and management of vendors including CRO and central independent reader.• Coordinated site selection and oversaw the site start-up process.• Tracked patient enrollment, site monitoring, and closeout activities, and coordinated data management activities.• Supported the creation and implementation of the electronic Case Report Form (CRF).• Managed the overall trial budget, drove site budget negotiations and investigator contracting decisions, teamed with the Wyeth Contracting and Legal departments, and ensured appropriate site and vendor payments were made and reconciled with the budget.• Coordinated and presented at Investigator Meetings.• Maintained study timelines and followed up and resolved audit findings.• Maintained study compliance with GCP, FDA, and ICH guidelines and Wyeth policies and procedures.• Assisted with therapeutic areas including Oncology, Hemophilia, and Transplant. Show less

Bachelor Of Arts, Chemistry

Applied Mathematics Minor

Mmse, Biopolymers

Master of Materials Science and Engineering