Andrea Demeter
Rocky River
Summary
Dedicated professional with extensive experience in oncology program leadership and strategic clinical operations. Known for aligning program strategies with operational metrics to optimize performance and deliver quality outcomes.
Overview
26
26
years of professional experience
Work History
Associate Director
Bristol Myers Squibb
Rocky River
10.2022 - Current
- Executed high-profile registrational trial (Checkmate 816), supporting successful sponsor-level inspections by FDA, EMA, PMDA, Health Canada, and TFDA.
- Contributed to development of first FDA-approved dual immunotherapy (nivolumab + ipilimumab) for first-line metastatic NSCLC.
- Directed international study teams and CRO partnerships to maintain standardized trial execution practices.
- Aligned program strategy with cross-functional governance to enhance collaboration among global development teams and stakeholders.
- Developed proactive frameworks using operational metrics to identify risks early and implement corrective measures.
- Enforced operational discipline across workstreams, ensuring consistent delivery of quality outcomes.
- Applied insights from operational metrics to protect project timelines, enhance quality standards, and optimize budget allocation.
Sr. Global Trial Manager
Bristol Myers Squibb
Rocky River
05.2021 - 09.2022
- Managed comprehensive execution of clinical trial projects, maintaining compliance with ICH-GCP standards.
- Governed risks, budgets, and timelines, ensuring data quality and minimizing disruptions to project execution.
- Acted as key liaison among internal teams, investigators, and vendors to enhance study execution and communication.
- Facilitated cross-functional collaboration to maintain project integrity and achieve performance metrics.
Clinical Research Manager
ExecuPharm (on assignment with Merck)
Rocky River
04.2018 - 04.2021
- Oversaw complete project management for numerous clinical trials, from feasibility to study closeout, ensuring timely milestone achievements.
- Developed oversight frameworks aligning monitoring efforts with ICH-GCP standards and regulatory compliance, enhancing overall trial integrity.
- Fostered collaboration among cross-functional teams and external partners to streamline study delivery processes, improving project timelines.
Clinical Data Analyst
YourEncore, Inc.
Rocky River
04.2017 - 03.2018
- Validated clinical data integrity and resolved anomalies to strengthen reporting quality across trials.
- Ensured oncology data accuracy by scrutinizing line listing datasets for renal cell carcinoma and ovarian cancer trials, enhancing data reliability for analysis.
- Conducted systematic reviews of oncology data to support study evaluation and uphold scientific reliability.
Sr. Clinical Project Manager
Otsuka Pharmaceuticals
Rocky River
06.2013 - 03.2018
- Monitored external service providers and CRO partners to maintain performance standards and adhere to study timelines, facilitating successful project milestones.
- Managed risk mitigation strategies for program delivery, advising clinical trial leads to enhance operational alignment and ensure timely project execution.
- Directed line listings and clinical study report development, streamlining global data review activities for more effective decision-making.
Project Manager
Novartis Vaccines and Diagnostics
Rocky River
05.2010 - 05.2013
- Directed end-to-end oversight of CRO-managed vaccine trial portfolio across 40+ US sites, ensuring adherence to GCP standards and on-time delivery.
- Revamped monitoring report processes by diagnosing quality issues and standardizing methods, improving clarity and timeliness of reporting.
- Detected monitoring integrity breaches at high-enrolling sites, implementing targeted interventions to maintain data credibility and prepare for audits.
Sr. Clinical Research Associate
Novartis Pharmaceuticals
Rocky River
10.2000 - 04.2010
- Managed U.S. and global CRA operations within solid organ transplant, oncology, cardiovascular, rheumatology, and neurology trials, guaranteeing quality monitoring and regulatory adherence.
- Developed risk-based corrective actions to address inefficiencies in timelines and budgets, enabling timely milestone achievements.
- Mentored CRAs and managers, enhancing clinical trial team operational proficiency.
Education
Bachelor of Arts - Psychology And Biology
Baldwin-Wallace College
Berea, OHSkills
- Clinical trial management
- Clinical trial leadership
- End-to-end study management
- Oncology program leadership
- ICH-GCP compliance and regulations
- FDA inspection readiness
- Risk-based quality management
- Trial master file oversight
- Oversight of vendors and CROs
- Site performance optimization
- Data integrity review
- Protocol compliance management
- Clinical study reporting
- Global portfolio leadership
- Strategic clinical operations
- Cross-functional stakeholder engagement
- Financial oversight
Accomplishments
- Strengthened global clinical trial delivery through leadership of cross-functional teams, mentoring of CRAs and Clinical Trial Leads, and enhancement of investigator and vendor collaboration models.
- Drove enterprise-level risk mitigation strategies by identifying trial inefficiencies early and implementing corrective actions that improved timelines, data quality, and operational performance.
- Restored compliance and operational integrity at high-enrolling clinical sites by executing targeted re-monitoring, resolving regulatory gaps, and ensuring successful audit and FDA inspection outcomes.
Timeline
Associate Director
Bristol Myers Squibb
10.2022 - Current
Sr. Global Trial Manager
Bristol Myers Squibb
05.2021 - 09.2022
Clinical Research Manager
ExecuPharm (on assignment with Merck)
04.2018 - 04.2021
Clinical Data Analyst
YourEncore, Inc.
04.2017 - 03.2018
Sr. Clinical Project Manager
Otsuka Pharmaceuticals
06.2013 - 03.2018
Project Manager
Novartis Vaccines and Diagnostics
05.2010 - 05.2013
Sr. Clinical Research Associate
Novartis Pharmaceuticals
10.2000 - 04.2010
Bachelor of Arts - Psychology And Biology
Baldwin-Wallace College