Erica (Rikki) Hodes
Chandler,AZ
Summary
Strategic Senior Manager known for productivity and efficiency in task completion. Skilled in leadership, operational strategy, and financial management. Excel at communication, problem-solving, and adaptability to drive team success and achieve organizational goals.
Overview
24
24
years of professional experience
Work History
Sr. Manager, Clinical Operations
PPD, part of Thermo Fisher Scientific
Chandler, AZ
03.2022 - Current
- Oversaw diverse clinical team of 16 CRAs and RSMs, managing selection, training, resourcing, coaching, and performance management to enhance team effectiveness.
- Lead and participate in initiatives that improve departmental performance and drive process improvements across PPD.
- Partnered with CTMs, senior management, and executive staff in Clinical Management to align clinical operations with strategic planning and drive business development.
- Led implementation of new monitoring model for key client, collaborating with project teams to ensure compliance with monitoring plans, adherence to client timelines, and delivery of high-quality results.
- Use metrics and Key Performance Indicators to drive and measure team performance, keeping a focus on desired outcomes.
Sr. Clinical Team Manager
ICON (formerly PRA Health Sciences)
Chandler, AZ
05.2016 - 03.2022
- Led day-to-day clinical team activities, setting priorities collaboratively.
- Executed clinical activities at project level, ensuring compliance with contractual and regulatory requirements while meeting time, quality, and budget constraints.
- Proactively identified and resolved risks and issues, escalating when appropriate.
- Coordinated with the study team to ensure adequate project resourcing; developed and maintained project plans and tools.
- Reviewed and approved trip reports for accuracy and protocol adherence, and addressed quality concerns in clinical deliverables.
- Ensured forecasted units were met within budget and escalated out-of-scope tasks.
- Acted as main contact for clinical monitoring issues, facilitating communication and collaboration among clients, vendors, and internal teams.
- Met database freezes and locks for primary and final analysis on time, with the final lock two days ahead of schedule.
Clinical Trial Manager
Insys Therapeutics
Chandler, AZ
12.2015 - 04.2016
- Oversaw site management activities outsourced to CROs for multiple Phase II-IV studies, ensuring compliance with Insys processes and regulatory requirements across the full study lifecycle (planning and feasibility through close-out).
- Conducted co-monitoring visits with CRO field monitors and management to assess site selection, protocol adherence, and key trial elements.
- Monitored site initiation progress and reviewed initiation reports; assisted with the trial execution plan and feasibility, training CRO monitors to enhance site recruitment readiness.
- Collaborated with CRO field monitors to ensure essential documents were in place for site initiation approval and initial/subsequent release of investigational product.
- Supported development and implementation of the site management oversight plan; confirmed monitoring visits followed the monitoring plan.
- Reviewed monitoring visit reports to identify quality and compliance issues, escalating to management and collaborating with CRO field monitors for resolution.
- Monitored and recorded CRO activities to ensure alignment with project milestones. and milestones against the contract/Scope of Work and budget.
- Identified potential protocol and operational challenges, escalated to management and developed suitable action plans.
Clinical Team Manager
ICON (formerly PRA Health Sciences)
Chandler, AZ
09.2012 - 12.2015
- Executed clinical activities at project level, consistently meeting contractual and regulatory requirements within established time, quality, and budget constraints.
- Planned and led day-to-day clinical team activities, and established priorities collaboratively.
- Proactively identified, resolved, and mitigated risks and issues, escalating as necessary.
- Monitored quality of clinical deliverables and proactively addressed concerns with appropriate team members to ensure compliance and standards.
- Worked closely with the study team to ensure adequate project resourcing; developed and maintained project plans, documents, and tools.
- Reviewed and approved trip reports for accuracy and protocol adherence.
- Served as primary liaison for clinical monitoring issues, effectively communicating with clients, vendors, and other functional areas within PRA to facilitate resolution.
- Ensured forecasted units were achieved within budget, escalating out-of-scope tasks.
- Met database freezes and locks for primary and final analysis on time, with the final database lock occurring two days ahead of schedule.
Sr. Clinical Research Associate
ICON (formerly PRA Health Sciences)
Chandler, AZ
09.2011 - 09.2012
- Executed and monitored clinical trials to ensure compliance with sponsor and investigator obligations under local regulatory requirements and ICH guidelines.
- Verified source documents, retrieved CRFs, resolved queries, and managed drug accountability and safety at investigative sites to ensure data integrity.
- Reconciled investigative site files and reviewed new/updated site documents for content, consistency, and compliance with local regulations, ICH guidelines, SOPs, and sponsor requirements.
- Reviewed serious adverse event (SAE) reports to confirm compliance with project specifications.
- Mentored junior CRAs and served as a resource for new employees.
Clinical Research Associate II
PharmaNet
Northbrook, IL
05.2009 - 09.2011
- Monitored pre-study, initiation, routine, and close-out visits at investigator sites (7580% travel) for GCP compliance per PharmaNet SOPs and/or client guidelines.
- Obtained, reviewed, and processed regulatory and administrative documents from investigator sites to ensure compliance with study requirements.
- Reviewed draft protocols for completeness and feasibility to facilitate timely study initiation.
- Reviewed and verified eCRFs and other clinical data in-house for completeness and accuracy; generated queries.
- Resolved CRF data queries with site personnel and developed case report forms for clinical trials.
- Trained junior CRAs on monitoring, internal procedures, and query resolution.
- Recruited investigators for participation in clinical trials and assessed study data tables and listings for accuracy and relevance.
Clinical Research Associate
ICON (formerly PRA Health Sciences)
Deerfield, IL
09.2007 - 03.2009
- Implemented and monitored clinical trials for compliance with sponsor obligations, local regulations, and ICH guidelines.
- Verified source documents and managed drug accountability and safety at investigative sites, ensuring compliance with regulatory standards.
- Ensured timely SAE reporting in accordance with project specifications to maintain trial integrity.
- Reconciled investigative site files and reviewed documents for content and regulatory compliance, facilitating audit readiness.
- Provided guidance to junior CRAs, enhancing their skills and confidence in the role.
Clinical Research Associate
INC Research (including Kendle and MDS)
Deerfield, IL
06.2006 - 08.2007
- Executed monitoring functions for Phase I-IV clinical research studies, enhancing understanding of drug development process, Good Clinical Practices, and relevant regulations.
- Managed study site activities, ensuring integrity of clinical data and compliance with regulatory guidelines and SOPs.
- Monitored ICON clinical trial sites for protocol compliance and source document accuracy.
- Conducted site initiation, monitoring, and closeout visits for assigned research protocols.
- Reviewed site regulatory files and TMF documents for PRA Health Sciences studies.
Clinical Data Associate
INC Research (including Kendle and MDS)
Deerfield, IL
04.2005 - 06.2006
- Tracked, reviewed, validated, and updated CRFs to ensure compliance with regulatory standards.
- Reviewed and processed clinical trial data to ensure accuracy and consistency.
- Reconciled similar data and reviewed listings, enhancing accuracy and completeness of clinical data for reporting.
- Tracked and reconciled data received for in-house review using existing CRF tracking tools.
- Applied corrections and updates to the clinical database and associated documents identified through query resolution, data entry, text review, site requests, computerized validation, and data importation.
- Operated clinical databases and software, generating reports and updating data to support accurate study outcomes.
- Provided accurate, timely, and consistent clinical data to sponsors and internal departments to support business needs.
Clinical Data Associate
Advanced Clinical Research Services
01.2003 - 04.2005
- Monitored project progress closely, reviewed, and validated CRFs to ensure data integrity and compliance with study protocols.
- Evaluated project documentation for accuracy and processed clinical trial data to ensure consistency.
- Reconciled data discrepancies and reviewed listings to enhance accuracy and completeness of clinical data.
- Tracked and reconciled data for in-house review, utilizing CRF tracking tools to support timely data management.
- Applied corrections and updates to the clinical database and associated documents identified through query resolution, data entry, text review, site requests, computerized validation, and data importation.
- Provided accurate, timely, and consistent clinical data to sponsors and internal departments to support business needs.
- Handled clinical software proficiently; computer software, laboratory, and clinical databases; reviewed data, generated reports, and updated data.
Education
Bachelor of Arts - Sociology
Arizona State University
Tempe, AZ08-1997
Skills
- Clinical operations
- Clinical Leadership
- Contract Research Organization (CRO)
- GCP compliance
- ICH-GCP
- CTMS expertise
- Medidata RAVE
- Veeva Vault
- ETMF
- Data Review
- Endpoint IRT
- Performance Metrics
- KPI tracking
- Risk Mitigation
- Mitigation Strategies
- Project Plans
- Resource allocation
- Trial management
- Site management
- Protocol review
- Monitoring oversight
- Budget oversight
- Data analytics
- Data-driven decisions
- Process improvement
- Performance coaching
- Team leadership
- Cross-functional team coordination
- Cross functional collaboration
- Vendor coordination
- Verbal and written communication
- Reporting oversight
- Problem solving
- Problem troubleshooting
- Attention to detail
- Analytical thinking
- Employee development
- Performance evaluation
- Talent Management
- Onboarding Programs
- Teamwork
- Staff management
- Microsoft Office
- Performance evaluation
- Employee development
- Analytical thinking
Personal Information
Title: Senior Manager of Clinical Operations
Timeline
Sr. Manager, Clinical Operations
PPD, part of Thermo Fisher Scientific
03.2022 - Current
Sr. Clinical Team Manager
ICON (formerly PRA Health Sciences)
05.2016 - 03.2022
Clinical Trial Manager
Insys Therapeutics
12.2015 - 04.2016
Clinical Team Manager
ICON (formerly PRA Health Sciences)
09.2012 - 12.2015
Sr. Clinical Research Associate
ICON (formerly PRA Health Sciences)
09.2011 - 09.2012
Clinical Research Associate II
PharmaNet
05.2009 - 09.2011
Clinical Research Associate
ICON (formerly PRA Health Sciences)
09.2007 - 03.2009
Clinical Research Associate
INC Research (including Kendle and MDS)
06.2006 - 08.2007
Clinical Data Associate
INC Research (including Kendle and MDS)
04.2005 - 06.2006
Clinical Data Associate
Advanced Clinical Research Services
01.2003 - 04.2005
Bachelor of Arts - Sociology
Arizona State University