James Clifford
San Antonio
Summary
Goal-driven research professional well-versed in recruiting, training and managing employees to provide exceptional resident services. Highly organized and hardworking with excellent planning and management skills. Over 12 years of experience in early phase clinical trials.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Director of Quality Assurance
DM Clinical Research
01.2022 - Current
- Direct quality assurance activities across the DM network, including study audits, in-process audits, data trending, risk assessment, quality management document development and CAPAs.
- Developed process and authored quality management documents for archival and retention of records, quality management of vendors, SOP creation and CAPAs.
- Directed the development of health matrix scoring; a data-driven risk-based dashboard demonstrating quality metrics across trials, sites and investigators.
- Developed audit guidelines and training material for QA staff.
- Direct laboratory operations of all PMBC processing labs in the DM network.
Director of Site Development and Integration
DM Clinical Research
09.2022 - 01.2024
- Strategized areas for new site openings in a Site Management Organization.
- Oversaw lease finalization, logistics and vendor management at new sites.
- Directed staffing, hiring and initial training at new sites.
- Oversaw quality control of all data generated by a site for the first year after opening.
- Directed issue detection and management to bring established and new sites into alignment and with standardized processes.
- Authored and reviewed quality management documents across various departments.
Director of Clinical Operations
Worldwide Clinical Trials
04.2020 - 07.2022
- Motivate and supervise over 150 direct and indirect reports.
- Manage Clinical Research Coordinators, medical, technical, scheduling, regulatory, participant experience management and data entry teams.
- Plan and manage adherence to budgets, decreased labor expenditures by 25% through creative scheduling and study execution.
- Developed systems and procedures for effective project management and clinical operations.
- Coach employees and support positive behavior and interactions with subjects and colleagues.
- Oversee clinical studies with focus on quality assessment, financial health and sponsor relations.
- Routinely review SOPs and Work Instructions for necessary changes and ensure compliance.
Associate Director of Clinical Conduct
Worldwide Clinical Trials
10.2015 - 04.2020
- Oversaw over 100 employees in 300 bed facility, including training, facilities, medical and technical departments as well as processing lab.
- Collaborated with method development scientists to analyze collection and processing procedures.
- Worked closely with quality assurance and regulatory departments to ensure compliance and highest level of data integrity.
- Decreased deviation rate by 40%.
- Routinely met with sponsor representatives to review site capabilities and preemptive risk mitigation.
- Ensured vendor delivery deadlines and requirements were met.
- Maintained GCP compliance by improving and aligning processes such as continuous training, deviation review and CAPA development / execution.
- Assisted senior leadership in managing all aspects of operations.
- Provided guidance in development of study protocols to both sponsors and internal medical writers.
Education
Associate of Science - Nursing
Excelsior College
Albany, NY09.2010
Skills
- Profit improvements
- Team Building
- Hiring and recruitment
- Seasoned in medical clinical procedures
- Training and mentoring
- Multidisciplinary team collaboration
- Occupancy strategies
- Project oversight
Certification
- Registered Nurse
Timeline
Director of Site Development and Integration
DM Clinical Research
09.2022 - 01.2024
Director of Quality Assurance
DM Clinical Research
01.2022 - Current
Director of Clinical Operations
Worldwide Clinical Trials
04.2020 - 07.2022
Associate Director of Clinical Conduct
Worldwide Clinical Trials
10.2015 - 04.2020
Associate of Science - Nursing
Excelsior College