Christopher Cavallaro
Pharmaceutical Research, Clinical Operations
Lafayette Hill,PA
Summary
Over 25 years of experience in the pharmaceutical industry, specializing in managing Phase II-IV clinical trials in Hematology, Respiratory, Oncology, CNS, Cardiovascular, and Women’s Health. Expertise in Data Monitoring Committee Management, ECG Central Reader Management, Endpoint Adjudication Management, charter and protocol development, patient recruitment, and site feasibility. Proficient in CFR, ICH/GCP guidelines, clinical trial processes, and software applications (SharePoint, Microsoft Office, Adobe products). Skilled in Software Development Life Cycle Management, Computer System Validation, Test Script Authoring, and Software Development Project Management. Certified Scrum Master with proficiency in Jira and Confluence, capable of managing multiple projects in fast-paced environments.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Director, Clinical Operations
Veralox Therapeutics
Frederick
11.2023 - Current
- Delivered the first Heparin Induced Thrombocytopenia (HIT) trial in over 20 years.
- Managed clinical trial vendors and CRO partner; facilitated Executive Committee and Clinical Operations meetings.
- Created clinical operations updates, tracked site activation/enrollment, and oversaw TMF submissions.
- Assisted in regulatory activities and monitored adherence to SOPs/Clinical plans.
Associate Director, Clinical Operations
inSeption group, LLC
Lansdale
12.2022 - 11.2023
- Defined project scope, resource allocation, and outsourcing strategies.
- Developed patient recruitment strategies, protocol development, and investigator recruitment.
- Oversaw operational aspects of clinical trials, including training, mentoring, and regulatory submissions.
Principal Project Manager
WCG ACI Clinical, LLC
Plymouth Meeting
09.2019 - 12.2022
- Managed Endpoint Adjudication, Data Monitoring Committees, and ECG Central Reader Projects.
- Authored Charters, Communication Plans, and Project Guidelines; mentored junior staff.
Product Manager – Endpoint Adjudication Application
ACI Clinical, LLC
Bala Cynwyd
12.2015 - 05.2019
- Delivered a web-based adjudication platform; authored system requirements and validation plans.
- Managed application development, quality testing, and user training.
Project Manager
WCG ACI Clinical, LLC
Bala Cynwyd
04.2011 - 12.2015
- Managed Endpoint Adjudication, Data Monitoring Committees, and ECG Central Reader Projects.
- Coordinated meetings, authored project documentation, and mentored junior staff.
Patient Safety Principal Scientist
AstraZeneca LP
Wilmington
01.2010 - 04.2011
- Managed Licensing Partner Safety Agreements and pharmacovigilance compliance.
- Developed tracking databases and dashboards for compliance monitoring.
Sr. Study Delivery Operations Specialist
AstraZeneca LP
Wilmington
10.2003 - 12.2009
- Executed Phase III Cardiovascular, Respiratory and Oncology studies; co-monitored clinical sites.
- Developed patient recruitment strategies and managed timelines/budgets.
Assistant Clinical Operations Manager
PharmaNet, Inc.
Bluebell
08.2002 - 08.2003
- Managed clinical trials, site start-up activities, and recruitment strategies.
- Reviewed protocols, CRFs, and regulatory documents; trained administrative staff.
Clinical Operations Coordinator
PharmaNet, Inc.
Essington
10.2001 - 08.2002
- Conducted site visits, managed IRB submissions, and prepared study materials.
Clinical Review Assistant
PharmaNet, Inc.
Essington
03.2001 - 10.2001
- Reviewed CRFs for accuracy and resolved data discrepancies.
Clinical Data Consultant
Wyeth-Ayerst Research
Radnor
10.2000 - 03.2001
- Reviewed CRFs for protocol adherence and maintained transaction logs.
Education
Master of Science - Biomedical Sciences
Philadelphia College of Osteopathic Medicine
08.2001
Bachelor of Arts - Biology
LaSalle University
06.1998
High School Diploma -
St. Joseph’s Preparatory High School
06.1994
Skills
- Clinical Trial Management (Phase II-IV)
- Data Monitoring Committee Management
- Endpoint Adjudication Management
- Patient Recruitment and Site Feasibility
- CFR, ICH/GCP Guidelines Compliance
- Software Development Life Cycle Management
- Computer System Validation
- Proficiency in SharePoint
- Proficiency in Microsoft Office
- Proficiency in Adobe Products
- Proficiency in Jira
- Proficiency in Confluence
Certification
Certified Scrum Master
Timeline
Director, Clinical Operations
Veralox Therapeutics
11.2023 - Current
Associate Director, Clinical Operations
inSeption group, LLC
12.2022 - 11.2023
Principal Project Manager
WCG ACI Clinical, LLC
09.2019 - 12.2022
Product Manager – Endpoint Adjudication Application
ACI Clinical, LLC
12.2015 - 05.2019
Project Manager
WCG ACI Clinical, LLC
04.2011 - 12.2015
Patient Safety Principal Scientist
AstraZeneca LP
01.2010 - 04.2011
Sr. Study Delivery Operations Specialist
AstraZeneca LP
10.2003 - 12.2009
Assistant Clinical Operations Manager
PharmaNet, Inc.
08.2002 - 08.2003
Clinical Operations Coordinator
PharmaNet, Inc.
10.2001 - 08.2002
Clinical Review Assistant
PharmaNet, Inc.
03.2001 - 10.2001
Clinical Data Consultant
Wyeth-Ayerst Research
10.2000 - 03.2001
Master of Science - Biomedical Sciences
Philadelphia College of Osteopathic Medicine
Bachelor of Arts - Biology
LaSalle University
High School Diploma -
St. Joseph’s Preparatory High School