Traci Thaler
Atlanta
Summary
Seasoned Clinical Operations Leader with broad experience in both team leadership and project delivery. Possesses strong strategic planning abilities, coupled with the capability to coordinate operational initiatives for maximum efficiency. Proven track record of driving process improvements, enhancing productivity, and implementing innovative solutions. Skilled in building strong relationships across all levels of an organization to achieve business goals. Possess exceptional work ethic and desire to go above and beyond to exceed company expectations.
Vast experience delivering large-scale complex clinical trials/programs (both US based and International), driving milestones including budget, timelines, and quality, and providing leadership to teams. Line Manager with multiple direct reports. Extensive complex Therapeutic Area expertise including but not limited to Psychiatry (Psilocybin/Psychedelics), Gene Therapy (Hemophilia, Duchenne Muscular Dystrophy), Rare Disease, Cardiovascular, Endocrine.
Overview
34
34
years of professional experience
1
1
Certification
Work History
Manager, Clinical Project Coordination
COMPASS PATHWAYS
01.2023 - Current
- Leading organization in mental health and psychedelic therapy
- Member of Clinical Operations Leadership Team (COLT), driving strategic initiatives and process improvements.
- Lead US operations team with seven direct reports.
- Manage ongoing line operations for US team (ongoing performance assessments, annual reviews, etc.), ensuring alignment with organizational goals.
- Recruited and hired qualified candidates, establishing a successful clinical operations team.
- Implement process enhancements as subject matter expert, developing, contributing to, and authoring standard operating procedures.
- Serve as site management issues expert and escalation point for operational challenges.
- Engaged internal and external stakeholders to gather insights, informing strategic planning to achieve study and organizational milestones.
- Facilitate training programs, enhancing staff capabilities and improving service quality.
Director, Study Management/Lead Study Manager (Rare Disease)
Pfizer Inc.
New York
01.2019 - 01.2023
- Led operational delivery of clinical trials ensuring that timeline, cost and quality goals are achieved.
- Managed assigned study managers and resources, ensuring timely delivery of all study management milestones.
- Coordinated project activities by liaising with Data Management, Regulatory, Quality, and Operations teams.
- Oversaw vendor-related activities and deliverables as primary contact for external vendors (CRO, Labs, and specialty vendors).
- Maintained inspection readiness protocols consistently.
- Expertise across multiple therapeutic areas including Rare Disease, Gene Therapy (Hemophilia, Duchenne Muscular Dystrophy), Endocrine and Cardiovascular diseases.
- Leading Pharmaceutical Company
Clinical Operations Study Team Lead (Rare Disease)
Pfizer Inc.
New York
01.2014 - 01.2019
- Leads operational delivery of clinical trials ensuring that timeline, cost, and quality goals are met.
- Developed and managed study deliverables (timeline targets and CTB/budgetary targets) as primary point of contact between internal and external functional groups, including study management, clinicians, data management, biostatistics, regulatory, legal, medical affairs, and finance.
- Ensured studies conducted in compliance with GCPs, relevant SOPs, and regulatory requirements while maintaining inspection readiness at all times.
- Led team to achieve project goals by coordinating tasks and fostering collaboration among members.
- Ensures team dynamic is healthy and facilitates decision-making and resolution of issues.
- Expertise across various therapeutic areas including Endocrine and Rare Diseases.
- Successfully bring studies to on-target DB lock and CSR submission.
- Managed CRO resources by addressing training requirements and ensuring compliance with project needs for Pfizer initiatives.
Project Manager
PHARMACEUTICAL PROJECT DEVELOPMENT (PPD) Inc.
01.2012 - 01.2014
- Global contract research organization providing comprehensive, integrated drug development
- Achieved timeline, cost, and quality goals throughout project lifecycle.
- Delivered clinical trials for client company, meeting all project specifications.
- Liaise with internal team of CRAs, Data Management, Biostatistics, Regulatory, Legal, etc to ensure Client milestones were met.
- Collaborated with client management to fulfill all human and financial resource requirements for successful delivery.
- Utilized project management skills to coordinate tasks and resources effectively.
Senior Study Manager / Protocol Operations Lead
Execupharm, inc.
PA
01.2007 - 01.2014
- On assignment to manage Pfizer protocols.
- Ensured delivery of clinical trials ensuring that timeline, cost, and quality goals are met.
- Supported Pfizer corporate-wide FDA audit in 2012/2013.
- Worked closely with VPs of Safety, Endocrine Care, and Legal to support questions from FDA auditors.
- Provided consulting services for professionals in pharmaceutical, biotech, and CRO industries.
Clinical Study Manager
Pfizer Inc.
New York
01.2000 - 01.2007
- Comprehensive study management of large-scale US-based and International clinical trials.
- Managed specialized programs, such as: The Atorvastatin Research Awards (ARA) Program;
- Oversaw specialized programs, including Atorvastatin Research Awards (ARA) Program, enhancing research visibility and participant engagement.
- Leading Pharmaceutical Company
Research Coordinator, Interventional Cardiology
Mount Sinai Hospital
New York
01.1996 - 01.2000
- One of the country’s oldest and largest voluntary teaching hospitals.
- Led team of research coordinators to manage and implement multiple clinical trials, ensuring adherence to protocols and timelines.
- Managed recruitment and enrollment of participants for clinical trials, optimizing processes to enhance participant engagement.
- Facilitated communication among researchers, participants, and healthcare providers to streamline information flow and support trial objectives.
- Maintained accurate records of all documents related to the research process, including consent forms, interview notes, survey results.
Cardiovascular Technologist
Pennsylvania Hospital
Philadelphia
01.1992 - 01.1994
- Contributed to operations at a major teaching and clinical research institution.
- Supported procedural activities in Cardiac Catheterization Laboratory to ensure efficient workflow.
- Assisted physicians during catheterizations and invasive procedures to enhance patient care.
Education
MBA - Marketing, Health Care Management
American Intercontinental University On-line
01-2005
BS - Exercise Science, Psychology
Ithaca College
01-1992
Skills
- Project leadership
- GCP/ICH compliance
- Vendor management
- Vendor and risk management
- Regulatory submissions
- Process improvement strategies
- Leadership and project management
- People management
Certification
- CCRA, Association of Clinical Research Professionals (ACRP), 2004
- CCRC, Association of Clinical Research Professionals (ACRP), 2000
- RCIS, Cardiovascular Credentialing International (CCI), 1993
Training
- Fierce TMF Summit, 03/2024
- Health Science Record & Archives Association (HSRAA) GxP Archives/Archivist course, 10/2024
Timeline
Manager, Clinical Project Coordination
COMPASS PATHWAYS
01.2023 - Current
Director, Study Management/Lead Study Manager (Rare Disease)
Pfizer Inc.
01.2019 - 01.2023
Clinical Operations Study Team Lead (Rare Disease)
Pfizer Inc.
01.2014 - 01.2019
Project Manager
PHARMACEUTICAL PROJECT DEVELOPMENT (PPD) Inc.
01.2012 - 01.2014
Senior Study Manager / Protocol Operations Lead
Execupharm, inc.
01.2007 - 01.2014
Clinical Study Manager
Pfizer Inc.
01.2000 - 01.2007
Research Coordinator, Interventional Cardiology
Mount Sinai Hospital
01.1996 - 01.2000
Cardiovascular Technologist
Pennsylvania Hospital
01.1992 - 01.1994
MBA - Marketing, Health Care Management
American Intercontinental University On-line
BS - Exercise Science, Psychology
Ithaca College