Allison G. Hale
Waxahachie,TX
Summary
Dynamic Senior Clinical Operations Manager at Bristol-Myers Squibb with extensive expertise in clinical trial operations. Proven track record in risk management and stakeholder engagement, leading teams to exceed performance metrics. Adept at conflict resolution and talent development, driving successful outcomes in complex clinical environments. Results-driven Clinical Operations Manager recognized for high productivity and efficient task completion. Possess specialized skills in clinical trial monitor management, and team leadership. Excels at communication, problem-solving, and adaptability, ensuring seamless operations and overall success.
Overview
35
35
years of professional experience
1
1
Certification
Work History
Senior Clinical Operations Manager
Bristol-Myers Squibb
Princeton, New Jersey
09.2022 - Current
- Supervises and coordinates the work assignments and performance of Clinical Operations staff that may be inclusive of Clinical Trial Managers (CTMs), Clinical Trial Monitors (CTMos), Study Start-up Specialists and/or Site Contract Leads to ensure timely execution consistent with R&D and local research goals and priorities.
- Demonstrates the ability to effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving, and crisis management.
- Anticipates resource needs and provides workload evaluations and task assignments.
- Allocates and assigns study resources in alignment with R&D and local research goals and priorities.
- Supervises clinical trial execution for assigned studies and team including supervising study metrics and team performance.
- Proactively identifies and escalates risks/gaps in BMS process.
- May approve study fee funds and payments based on grant of authority.
- May propose and/or validate study targets.
- May support Health Authority inspection and pre-inspection activities.
- May support audit preparation & Corrective Action / Preventative Action preparation for related issues.
- Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources/tools are available.
- With management, develops goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met.
- Together with RCO management tracks and manages performance metrics for Clinical Operations staff.
- Anticipates and initiates action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit.
- Point of Contact for assigned FSP staff.
- Managing the hiring, performance management, and succession planning of direct reports.
- Performing general and human resource administrative functions.
- Participation in performance calibration and talent review meetings.
- Ensures collaboration and information sharing with local country cross-functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources).
- Contributes to effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and/or Health Authorities as needed.
- Manages/oversees partnerships with critical accounts/sites for assigned studies and therapeutic areas.
Senior Clinical Site Monitor
Bristol-Myers Squibb
Princeton, New Jersey
03.2002 - 08.2022
- Overall monitoring of clinical trials at investigative sites, regionally for multiple therapeutic areas (cardiovascular, immunology, metabolic diseases, oncology, anti-infective).
- Assure that clinical trials are conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and ICH guidelines.
- Review investigator/coordinator source documentation and review/verify data recorded on case report forms via electronic systems utilizing 100% Source Data Verification (SDV), Reduced SDV and Risk-Based Monitoring strategies.
- Perform initiation, monitoring, and close-out visits utilizing SOPs, FDA regulations, and ICH guidelines.
- Perform above duties via regional home office.
Clinical Site Monitor
Bristol-Myers Squibb
Princeton, New Jersey
12.1999 - 02.2002
- Assure that clinical trials are conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and ICH guidelines.
- Review investigator/coordinator source documentation and review/verify data recorded on case report forms via electronic systems utilizing 100% Source Data Verification (SDV), Reduced SDV and Risk-Based Monitoring strategies.
- Perform initiation, monitoring, and close-out visits utilizing SOPs, FDA regulations, and ICH guidelines.
- Perform above duties via regional home office.
Associate Clinical Site Monitor
Bristol-Myers Squibb
Princeton, New Jersey
12.1997 - 11.1999
- Assure that clinical trials are conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and ICH guidelines.
- Review investigator/coordinator source documentation and review/verify data recorded on case report forms via electronic systems utilizing 100% Source Data Verification (SDV), Reduced SDV and Risk-Based Monitoring strategies.
- Perform initiation, monitoring, and close-out visits utilizing SOPs, FDA regulations, and ICH guidelines.
- Perform above duties via regional home office.
Clinical Research Associate
IBRD-Rostrum Global, Inc.
Irvine, California
04.1996 - 10.1997
- Overall management of clinical trials at investigative sites.
- Performing initiation visits, routine monitoring visits, and close-out visits utilizing FDA/corporate SOPs and guidelines.
- Ensuring proper completion and submission of regulatory documents.
- Reviewing investigator source documentation and reviewing case report forms.
- Extensive travel in the Central and Northeastern regions of the United States.
Director of Clinical Trials/Outpatient Dobutamine Therapy
Clinics of Drs. Iteld, Mautner, & Bernstein
Chalmette, Louisiana
05.1994 - 04.1996
- Management and supervision of a four-person department which encompasses Cardiovascular Clinical Trials (4-9 simultaneously) and Outpatient Dobutamine Treatments (30-40 patients weekly).
- Formulation of departmental quarterly reports showing cost savings and formulation of budgets for all clinical trials.
- Completion and submission of all Food and Drug Administration and Institutional Review Board forms pertaining to each study.
- Monthly collaboration with Pharmaceutical Company and Contract Research Organization representatives regarding all phases of ongoing studies.
- Attendance at various Investigator Meetings nationwide for protocol discussion, study initiation, and study completion.
Research Coordinator/Dobutamine Nurse
Clinics of Drs. Iteld, Mautner & Bernstein
Chalmette, Louisiana
02.1994 - 05.1994
- Coordinator participation for 4-9 protocols simultaneously, including but not limited to, patient visits and case report form completion.
- Perform interim research visits including patient histories, physical assessments, phlebotomy, 12 lead ECGs, medication assessments, and other study-related procedures.
- Invasive hemodynamic monitoring (including cardiac parameters) for 3 of the 9 protocols requiring Swan Ganz insertion in an ICU setting.
- Screening of charts for appropriateness with regard to inclusion/exclusion criteria.
- Initiation and administration of IV Dobutamine to chronic and acute congestive heart failure patients in an outpatient setting.
- Assessment and evaluation of patients receiving IV Dobutamine including continuous telemetry.
- Calculation and preparation of drips for each patient.
- Coordination of Home Health Care/Inpatient Admissions as needed.
Quality Assurance/Utilization Review Coordinator
Principal Health Care of Louisiana, Inc.
Metairie, Louisiana
09.1993 - 02.1994
- Coordination of all health care needs of patients in acute care, extended care, or home care settings to provide continuity of care.
- Resource/Consultant to participating physicians and ancillary care providers concerning benefit options.
- Monitor and implement utilization and quality assurance policies of PHCLA.
- Assessment of patient records to determine medical necessity with regards to outpatient procedures, admission, and continued stay review.
- Encourage cost containment through case management, and education of providers and patients regarding alternative modalities of care.
Case Manager
First Health
Salt Lake City, Utah
11.1992 - 08.1993
- Analyze information submitted by providers to make timely review determinations based on medical necessity of inpatient/outpatient/rehabilitation treatment.
- Conduct appropriate referrals relative to individual cases (MD Review, Catastrophic Case Management).
- Initiation and follow-up of discharge planning.
- Concurrent and retrospective case review and fee negotiation.
Staff RN-Surgical Intensive Care Unit
University of Utah Medical Center
Salt Lake City, Utah
01.1991 - 08.1993
- Primary care of critically ill patients including cardiac and renal transplant, cardiothoracic, complex surgical, multiple trauma, and multi-system organ failure patients.
Education
Master of Science - Clinical Research Administration
Walden University
Minneapolis, MN01.2013
Bachelor of Science - Nursing
Louisiana State University Medical Center School of Nursing
New Orleans, LA01.1990
Skills
- Clinical trial operations
- Regulatory compliance
- Risk management
- Performance metrics
- Study resource allocation
- Quality assurance
- Stakeholder engagement
- Effective communication
- Conflict resolution
- Talent development
- Team leadership
- Problem solving
- Employee engagement
- Managerial experience
- Staff supervision
Certification
- Certified Clinical Research Associate (ACRP), 2000 - 2020
- Registered Nurse, Texas, 1997 - Present
- Certified Clinical Research Coordinator (ACRP), 1996 - 11/2000
- Registered Nurse, Louisiana, 1993 - 1999 (inactive status at present)
- Registered Nurse, Utah, 1991 - 2001 (state of initial licensure-not allowed to maintain licensure without state residency)
Bms Id
00092000
Current Position
Senior Manager – Clinical Operations Site Monitoring
Affiliations
- Volunteer Alzheimer Walk, Dallas, TX
- Volunteer, Lupus Walk, Dallas, TX
Languages
English
Professional
Timeline
Senior Clinical Operations Manager
Bristol-Myers Squibb
09.2022 - Current
Senior Clinical Site Monitor
Bristol-Myers Squibb
03.2002 - 08.2022
Clinical Site Monitor
Bristol-Myers Squibb
12.1999 - 02.2002
Associate Clinical Site Monitor
Bristol-Myers Squibb
12.1997 - 11.1999
Clinical Research Associate
IBRD-Rostrum Global, Inc.
04.1996 - 10.1997
Director of Clinical Trials/Outpatient Dobutamine Therapy
Clinics of Drs. Iteld, Mautner, & Bernstein
05.1994 - 04.1996
Research Coordinator/Dobutamine Nurse
Clinics of Drs. Iteld, Mautner & Bernstein
02.1994 - 05.1994
Quality Assurance/Utilization Review Coordinator
Principal Health Care of Louisiana, Inc.
09.1993 - 02.1994
Case Manager
First Health
11.1992 - 08.1993
Staff RN-Surgical Intensive Care Unit
University of Utah Medical Center
01.1991 - 08.1993
Master of Science - Clinical Research Administration
Walden University
Bachelor of Science - Nursing
Louisiana State University Medical Center School of Nursing
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