Danelle McDougal
Edmond,OK
Summary
Accomplished Clinical Operations Manager with nineteen years Clinical experience at IQVIA. Adept in overseeing clinical trial management and enhancing team performance and output. Skilled in ICH GCP knowledge and effective communication, I excel in driving operational excellence and compliance. Responsible for oversight of metrics, CAPA submissions, clinical trial processes and mentoring teams for peak performance. Excels in working with internal and external cross functional teams. Significant leadership background directing multidisciplinary performance management and performance review.
Overview
18
18
years of professional experience
Work History
Clinical Operations Manager
IQVIA Biotech
01.2023 - Current
- Oversees a team of 20 Clinical Trial Managers to ensure the successful management of clinical trials, performance and career development.
- Responsible for overseeing CAPA execution, root cause analysis and timely submission/approvals.
- Responsible for training CTMs for Bid Defense preparation, sales proposals and presentations.
- Responsible for managing change in scope review and budget reconciliation and submission of change notification forms.
- Support cross collaboration in feasibility, country selection, regulatory and ethic submissions, site start-up and operational input to study design and risk based monitoring.
- Assures compliance with ICH GCP and Standard Operating Procedures.
- Evaluated and analyzed clinical feedback to identify areas of lean process management.
- Coordinated multidisciplinary team meetings to discuss complex cases and devise individualized performance enhancement plans for low performing individuals.
Senior Global Clinical Team Leader
IQVIA
04.2016 - 01.2023
- Responsible for the Clinical Delivery of the study from Site Selection and Start-up to Database lock and Close-Out.
- Managed clinical team of 50 including but not limited to regional Clinical Leads, Clinical Research Associates, Clinical Support.
- Created and Developed plans including but not limited to the Clinical Operations Plan, Risk Management, Safety management, Recruitment Strategy, etc.
- Responsible for collaborating with other functional groups for the successful delivery of the study such as Global Delivery Network, , Data Management, Pharmacovigilance, Biostatistics, Site Start-up.
- Oversaw CAPA submission and reconciliation.
- Enhanced team efficiency by performing regular training, feedback and support to clinical staff.
Clinical Research Specialist
IQVIA
04.2013 - 04.2016
- Verified Clinical monitoring task were conducted in accordance with protocol, process, quality standards and expectations per Contract.
- Ensured regulatory compliance by maintaining up-to-date knowledge of industry standards and guidelines.
- Contributed to successful FDA approval of product with diligent management of investigational studies.
- Trained junior research staff members on proper procedures and protocol adherence, elevating overall team performance.
Senior Clinical Research Associate
IQVIA
12.2006 - 04.2013
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Communicated project status to Clinical Team Lead/Clinical Lead management verbally and through technical documentation and presentations.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Managed project risk by identifying, quantifying and monitoring potential threats.
Education
Bachelor of Science - Health Promotions
Liberty University
Lynchburg, VA05.2005
Skills
- ICH GCP Knowledge
- Adverse event reporting
- Site monitoring
- Clinical trial management
- Clinical Data Management
- Patient recruitment
- Audit preparation
- Investigator relations
- Document Management
- Protocol development
- Clinical Research
- Study design
- Clinical Leadership
- Effective Communication
- Managerial experience
- Training and mentoring
- Supervisory Experience
- Onboarding and coaching
- Clinical education
- Developing training programs
- Team Management
- Quality Improvement
- HIPAA
- Staff Supervision
- Clinical Quality Improvement
- Staff Development
- Operations Oversight
- Records Management
- Utilization review
- Recruitment and retention
- Critical Thinking
- Decision-Making
- Employee Recruitment and Hiring
- Multidisciplinary team collaboration
- Employee Performance Evaluations
- Employee Supervision
- Regulatory Compliance
- Proficient in [Software]
Timeline
Clinical Operations Manager
IQVIA Biotech
01.2023 - Current
Senior Global Clinical Team Leader
IQVIA
04.2016 - 01.2023
Clinical Research Specialist
IQVIA
04.2013 - 04.2016
Senior Clinical Research Associate
IQVIA
12.2006 - 04.2013
Bachelor of Science - Health Promotions
Liberty University