Willow Azooz
Anacortes,WA
Summary
Strong Data Management experience with a proven track record spanning 28 years in all things data management, study start up to database lock/decommissioning, experience at the sponsor and CRO, Phase I to IV, multi-national long-term follow-up/survival studies and multiple therapeutic areas. Translate expectations from Sponsor to CRO and vice versa. Experience in multiple clinical databases. Managed up to 16 people and acted as an Operations Lead for Medidata RAVE clients, created standards and updated current work practices to globalize as well as created templates necessary for system specific documentations. Led internal and external audits. Coaching, mentoring, and training individuals for about 10 years additionally, creating training plans for others to follow.
Overview
35
35
years of professional experience
1
1
Certification
Work History
Manager, Clinical Data Management
Emmes
03.2022 - 01.2024
- Oversaw implementation of data management aspects of clinical protocols and data collection systems
- Provided strategic input into proposal or protocol design focused on data management considerations
- Mitigated potential data management issues by reviewing protocols for cross-project consistency and identified standard case report form modules to meet objectives
- Reviewed DM activities, recommended process improvements, and ensured adherence to departmental standards
- Maintained high-level oversight on data quality metrics and DM deliverables and ensured compliance with therapeutic area standards
- Provided leadership for the DM team through mentoring, training, and coaching
- Collaboratively conducted performance and compensation review activities with the applicable project leader or designee
- Responsible for addressing employee relations issues and resolving problems
- Assessed and monitored new DM training and documentation
- Provided department or therapeutic area specific training on DM processes and procedures
- Provided support for DM department initiatives and objectives through engagement of DM staff
- Served as therapeutic area representative in department and corporate meetings
- Supported new and existing customer relationships and served as a DM representative for external meetings/conferences
- Modeled and reinforced the corporate culture through vision, action, and learning
- Created templates and documents to support new processes
- Participated in standards and work process creations and annual updates
- Direct supervision of 10 employees plus 6 project specific employees
- DM Point of Contact for internal and external audits and served as Biopharma Medidata Rave projects Data Operations Lead.
Manager, Clinical Data Manager
NAMSA (Legacy Clinlogix)
09.2021 - 03.2022
- Managed a group working with various clients and projects on clinical research data management and database development and validation in the medical device industry
- Managed relationships with vendors providing database software to NAMSA Clinical
- Allocated staff for projects – hourly and project-based
- Acted as the principal spokespersons and as the company’s primary interface with the external customers
- Negotiated technical, schedule and quality issues with the customer and utilized Executive Management support as needed
- Reviewed cost and technical progress as compared to contractual requirements on a continual basis; took appropriate actions to resolve issues and achieve client satisfaction
- Participated in NAMSA Clinical Operations Management Meetings
- Negotiated cost-related issues with the customer
- Wrote and managed project estimates and proposals as needed
- Worked collaboratively with cross-functional teams to increase company efficiencies
- Identified and guided process improvement projects
- Updated Departmental Data Management SOPs, Work Instructions, and Guidelines
- Prepared for and participated in client and regulatory agency audits; maintained audit readiness within the Department.
Principal Lead Data Manager
Clinlogix, LLC (NAMSA Companies LLC ACQUIRED)
06.2019 - 08.2021
- Identified EDC impact assessments for protocol amendments
- Provided leadership and oversight for assigned projects, achieving all deliverables in the agreed upon timelines
- Proactively identified challenges and risks while providing recommendations for resolution
- Performed ongoing Data Management (DM) activities, including but not limited to data review and query management based on programmed edit checks, externally generated listings, Data Review Guidelines (DRGs) and Data Quality Reviews (DQRs)
- Led data management activities on complex projects where analysis of situations or data required an in-depth evaluation of variable factors
- Performed external vendor data processing, external vendor data reconciliation, SAE Reconciliation, and Coding
- Provided oversight of external vendors to ensure all external data transfer specifications were defined including transfer agreements
- Provided data review metrics, query metrics and other metrics as assigned to internal and external teams to support KPIs
- Authored and maintained DM documents, including but not limited to the Data Management Plan, User Acceptance Testing (UAT) Plan, eCRF Completion Guidelines, Edit Check Specifications, Data Quality Review Plan, Custom Report Specifications and Data Review Guidelines
- Maintained the Data Management (DM) section of the Trial Master File (TMF)
- Coordinated with Clinical Project Assistant (CPA) for storage of DM documents within the Trial Master File (TMF) and electronically on shared drives for DM and related functional groups
- Performed EDC User Acceptance Testing (UAT) as assigned and maintained associated documentation
- Performed DM finalization activities for all deliverables
- Rescued two studies and changed client’s perception of previous lead/company which led client to award additional studies
- Identified and coordinated activities related to process improvement initiatives, corrective action plans and quality initiatives
- Mentored and trained other data management team members supporting professional growth and career development
- Wrote and reviewed new and existing SOPs for annual updates and initiation of new processes
- Assisted with and participated in Bid Defense Meetings, Kick Off Meetings, and other client meetings as well as clinical site trainings at Investigator Meetings
- Understood Key Performance Indicators (KPIs) and provided metrics to Sr
- Leadership highlighting when metrics were meeting the established KPIs or when they were at risk (developed mitigation plans)
- Was responsible for recognizing project data backlogs and implementing effective resolution plans
- Advanced ability to proactively identify potential risks, with confidence and without prompting, represent Data Management internally and externally for all study related items and find pragmatic solutions in compliance with regulatory requirements and in accordance with SOPS
- Adapted style and used persuasion in delivering messages on complex issues to audiences with divergent perspectives.
Senior Clinical Data Manager
Lab Corp
10.2016 - 06.2019
- Acted as the lead during client partnership meetings to include understanding and communicating client standards and incorporating company processes
- Identified and implemented solutions to project data management issues and concerns, including proactive prevention strategies based on metrics, risks and forecasts
- Coordinated and participated in the development of the clinical data model and/or database design and annotated the CRF (eCRF) according to the specifications
- Reviewed data acquisition conventions and data review guidelines / ensured diagnostic specification were consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions
- Interacted and collaborated with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to lead the set-up, maintenance, and closure of all project data management aspects to ensure consistent, cohesive data handling and quality
- Advanced planning and risk management for projects (issue escalation, resource management)
- Oversaw the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time, and on-budget
- Assisted with goal creation and performance review assessment for data review project staff
- Maintained technical data management competencies by participation in internal and external training
- Served as a mentor to new employees and a point of contact for clarifying and interpreting SOPs
- Acted as Xcellerate Reporting and Data Review Change Agent representing Clinical Data Management.
Senior Clinical Program Data Manager
Chiltern (Lab Corp Acquired)
02.2015 - 06.2016
- Managed Compounds in multiple phases of clinical development including timelines, documentation, communications, study status, resources, startup, snapshot, and close/lock procedures/efforts, risk assessments, timeline reductions
- Ensured medical coding and queries were issued and closed in timely manner while communicating and working with teams imitating improvements to minimize issues
- Ensured coding consistency between programs, projects, and dictionary versions
- Ensured reconciliations completed according to timelines; including external data, serious adverse events, and coding
- Ensured data reviews were conducted as expected to reduce timelines and gain efficiencies
- Performed gap analysis and implemented training in areas of improvement affecting functional areas and external partners
- Served as a liaison between Biostatistics, Clinical Research, Medical Monitors, and other Functional Areas.
Lead Program Clinical Data Manager
Takeda Pharmaceuticals
10.2009 - 02.2015
- Worked with Alliance partnerships and transition studies
- Performed function assessments, gap analysis, ROI analysis and standards guidance
- Defined data captures requirements and vendor strategies to meet requirements of global development programs
- Ensured timely processing and validation of clinical study data in accordance with the data management plan and all other applicable documentation
- Directed work of external vendors providing data capture technologies and data processing capabilities to achieve quality, timely and cost-effective study deliverables
- Represented the data management function in support of assigned global clinical studies and programs led from the United States while adhering to regulatory requirements and maintained standards while followed SOPs
- Managed Analytical Sciences project plans, reported progress of all deliverables, identified, and resolved issues, coordinated activities with the project team and management
- Provided study level updates: Anticipated and communicated resourcing and quality issues that may have impacted deliverables or timelines: Aligned learning’s within group for the benefit of other teams.
Director of Data Management
Delta-Pharma
06.2005 - 11.2009
- Oversaw a team of 12 who were dedicated to specific clients, locations on and off site
- Ensured clients were receiving the quality data for deliverables
- Worked with the proprietary system to ensure the team was updating and maintaining appropriate
- Assisted with Business Development presentations and meetings
- Created training programs to ensure the data management team was prepared for all activities to support deliverables
- Worked on company standards and processes.
Lead Data Manager
Neopharm
01.2003 - 06.2005
- Oversaw orphan oncology studies
- Oversaw the quality of data from outsourced agency
- Assisted with coding
- Provided metrics
- Provided training as needed
- Prepared presentations for leadership.
Data Manager
Searle Pharmaceuticals
12.1992 - 12.2002
- Oversaw outsourced studies for an international phase 3 study
- Performed Study Coordinator and Investigator training
- Assisted with coding and reviewed coding reports
- Created CRF books for sites
- Assisted with reviewing monitoring reports
- Provided metrics to leadership.
Classification and Training Specialist
USAF
09.1988 - 04.1992
- Evaluated training requirements to job specialty
- Provided recommendation to Headquarters for individual job changes
Education
Bachelor of Science in Business Management -
UNIVERSITY OF PHOENIX
01.2005
Skills
- Team Leadership
- Time Management
- Verbal and written communication
- Complex Problem-Solving
- Strong experience with creating work practices and procedures
- Ability to collaborate effectively/encourage out of the box thinking
- Ability to train and coach
- Employee engagement 87%
Websites
Therapeutic Experience
Device Studies, Hypertension, Peripheral Arterial Disease, Psoriasis, Eczema, Atopic Dermatitis, Acne, Type II Diabetes, Other Metabolic Disorders, Bacterial / Viral Vaccines, Depression, Acute Pain, Brain Tumors, Glioblastoma, Orphan Disorders, Lung Cancer, Pediatric Blood Cancer, Macular Degeneration
Certification
- PMP, Syracuse University - Expected completion Sep, 2024
Timeline
Manager, Clinical Data Management
Emmes
03.2022 - 01.2024
Manager, Clinical Data Manager
NAMSA (Legacy Clinlogix)
09.2021 - 03.2022
Principal Lead Data Manager
Clinlogix, LLC (NAMSA Companies LLC ACQUIRED)
06.2019 - 08.2021
Senior Clinical Data Manager
Lab Corp
10.2016 - 06.2019
Senior Clinical Program Data Manager
Chiltern (Lab Corp Acquired)
02.2015 - 06.2016
Lead Program Clinical Data Manager
Takeda Pharmaceuticals
10.2009 - 02.2015
Director of Data Management
Delta-Pharma
06.2005 - 11.2009
Lead Data Manager
Neopharm
01.2003 - 06.2005
Data Manager
Searle Pharmaceuticals
12.1992 - 12.2002
Classification and Training Specialist
USAF
09.1988 - 04.1992
Bachelor of Science in Business Management -
UNIVERSITY OF PHOENIX
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