Blaine A. Maloney
Spring Hill,TN
Summary
Global leader in site activation and identification with a proven track record in global expansion and process optimization. Expertise in reducing department cycle times while managing diverse teams and resources effectively. Extensive experience in international clinical trials across multiple regions, ensuring compliance with drug, biologic, and medical device regulations. Strong background in strategic planning, team development, and performance management, resulting in improved productivity and operational success.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Associate Director, Central Site Services
Catalyst Clinical Research
Wilmington, USA
2021 - Current
- Led global site activation and identification teams, covering site selection and regulatory affairs.
- Directed CSS team line management, ensuring adherence to SOPs and ICH GCP guidelines.
- Managed operational execution of site identification, activation, and management activities.
- Provided leadership for clinical applications like CTMS, eTMF, and site payment systems.
- Oversaw investigator grant payments through Catalyst Finance or third-party providers.
- Developed regulatory startup pathways for North America, Europe, Asia, and Latin America.
- Monitored budgeting, forecasting, and reporting to enhance departmental efficiency.
- Implemented strategies to increase organizational effectiveness, driving continuous improvement.
Site Activation Manager
ICON Clinical Research
Brentwood, USA
2011 - 2021
- Managed overall project portfolios and site activation personnel across multiple initiatives.
- Coordinated and led projects to meet established timeframes and targets effectively.
- Ensured quality standards, customer satisfaction, and cost management in all operations.
- Developed and implemented strategies for process improvement across client portfolios.
- Identified and executed process enhancements to streamline operations and add value.
- Oversaw compliance with ICH, GCP, and regulatory requirements for submissions.
- Trained personnel as subject matter expert while enhancing team capabilities.
- Facilitated communication between stakeholders to optimize collaboration efforts.
Regulatory Affairs
Sarah Cannon Research Institute
Nashville, USA
2010 - 2011
- Managed high-performance regulatory department, ensuring compliance with agency standards.
- Served as primary regulatory contact during FDA audits, facilitating document staging and conflict resolution.
- Conducted hiring processes for regulatory department, enhancing team capabilities with targeted job descriptions.
- Developed and implemented SOPs and WPGs across departments, streamlining internal processes.
- Led cross-departmental trainings to promote regulatory knowledge and best practices.
- Oversaw cross departmental projects, ensuring alignment with regulatory requirements and objectives.
- Authored and revised informed consent templates, maintaining ethical standards in clinical trials.
- Monitored industry trends in regulatory affairs, providing updates to management for strategic decisions.
Education
Master of Science - Regulatory Affairs: Drugs, Biologics, and Medical Devices
Northeastern University
Boston, MA01-2011
Bachelor of Science -
Clemson University
Clemson, SC01-2009
Skills
- Site activation and management
- Regulatory compliance
- Budget negotiation and development
- Team leadership
- Project coordination
- Process improvement
- Clinical trial oversight
- Client relationship management
- Strategic planning
- Effective communication
- Critical thinking
- Time management
- Data analysis
- Public speaking
- Facilitation skills
- Organizational development
- Resource allocation
- Systems development
- Expense control
- Staff scheduling and evaluation
- Financial administration
- Program development
- Database management
- Professional networking
- Operations management
- Diversity and inclusion initiatives
- Crisis management techniques
Affiliations
- Regulatory Affairs Professional Society (RAPS)
- Drug Information Associate (DIA)
Certification
European Medicines Agency Clinical Trials Information System Sponsor User Training Programme, 2022
Speaking Engagements
Society of Clinical Research Sites Oncology Summit, Navigating the Global Regulatory Landscape, 04/20/24, Atlanta, GA
Publications
- Unpacking Industry Hurdles, Maloney, Blaine, 04/25/24, https://catalystcr.com/unpacking-industry-hurdles/
- Ensuring Flexibility when Approaching CTIS, Maloney, Blaine, and Ines Vale de Gato, Journal for Clinical Studies, 16, 2, 07/24, 6-7, https://issuu.com/senglobal1/docs/2024-jcs-summer-web_compressed_fd5c44c3a657f2?fr=xKAE9_zU1NQ
Therapeutic Indications
- Oncology
- Immunology
- Lung Cancer
- Non-Small Cell Lung Cancer
- Breast Cancer
- Hematological Oncology
- Large B-Cell Lymphoma
- Hodgkin’s Lymphoma
- Non-Hodgkin’s Lymphoma
- Solid Tumor Malignancies
- Renal Cell Carcinoma
- Small Cell Lung Carcinoma
- Melanoma
- Myeloma
- Leukemia
- Chronic Lymphocytic Leukemia
- Acute Myeloid Leukemia
- Small Lymphocytic Lymphoma
- Colorectal Cancer
- Prostate Cancer
- Unknown Primary
- Graft-versus-host disease (GVHD)
- Myelodysplastic Syndrome
- Gastrointestinal Cancers
- Glioblastoma
- Neurology
- Parkinson’s Disease
- Amyotrophic Lateral Sclerosis (ALS)
- Vasomotor Symptoms
- Alzheimer’s Disease
- Vaccines
- Influenza
- Respiratory Syncytial Virus
- Small Pox
- COVID-19 (SARS-CoV-2)
- Rare Disease
- Erythropoietic Protoporphyria
- Systemic Sclerosis
- Thymidine Kinase 2 (TK2) Deficiency
- Classic Galactosemia
- Metabolic Disease
- Type 1 and Type 2 Diabetes
- Aesthetics
- Wrinkles
- Glabellar lines
- Nephrology
- Renal
- Urology
- Diabetic Kidney Disease
- Autosomal Dominant Polycystic Kidney Disease
- Human Immunodeficiency Virus (HIV)
- GI Disorders
- Crohn’s Disease
- Ulcerative Colitis
- Irritable Bowel Disease
- Celiac Disease
- Biosimilars
- CAR-T / Cell Therapy
- Gene Therapy
- Radiopharmaceuticals
Regions Experience
US, Canada, Argentina, Brazil, Colombia, Mexico, Peru, Chile, Puerto Rico, Dominican Republic, United Kingdom, Ireland, Germany, Greece, France, Denmark, Italy, Poland, Belgium, Austria, Czech Republic, Ukraine, Russia, Hungary, Romania, Iceland, Sweden, Finland, Spain, Belarus, Bulgaria, Croatia, Latvia, Netherlands, Serbia, Slovakia, Switzerland, Georgia, Turkey, Lithuania, Portugal, Norway, Australia, New Zealand, South Korea, Japan, Israel, Thailand, Philippines, Taiwan, India, China, Singapore, Hong Kong, Malaysia, South Africa, Uganda, Kenya, Eswatini
Timeline
Associate Director, Central Site Services
Catalyst Clinical Research
2021 - Current
Site Activation Manager
ICON Clinical Research
2011 - 2021
Regulatory Affairs
Sarah Cannon Research Institute
2010 - 2011
Master of Science - Regulatory Affairs: Drugs, Biologics, and Medical Devices
Northeastern University
Bachelor of Science -
Clemson University