Mindy O’Neil Email & Phone Number

Kansas City, Mo, Us

• Led 21 direct reports, improving efficiency and exceeding productivity metrics. Hired and retained a motivated team, reducing turnover.• Provided technical support and ensured training compliance with SOPs and systems, maintaining staff compliance.• Facilitated professional development, offering opportunities for technical and soft skills growth.• Conducted performance management and resolved Full-Service Provider (FSP) Operations issues with action plans and escalations.• Reviewed CVs and clarified roles for new or transitioning staff, ensuring smooth onboarding.

Kansas City Metropolitan Area

• Managed FSP account growth by creating role-based growth plans, job descriptions, contracts, and work orders, expanding program scope.• Developed and managed communication and escalation plans for FSP services, improving client relationships and streamlining communication.• Contributed to RFP processes and bid defense meetings, acquiring new business and retaining key clients.• Chaired FSP meetings, tracked compliance with KPIs, and managed issue resolution, ensuring adherence to contractual requirements.• Authored and delivered training modules for FSP program management, enhancing staff capabilities and ensuring consistent quality.

Kansas City Metropolitan Area

• Executed and oversaw program management activities for two FSP client programs, ensuring alignment with client needs and timelines.• Acted as central POC between senior management and key client personnel, coordinating contracted FSP Operations activities and ensuring smooth communication.• Planned and managed logistics, infrastructure, and resources for FSP services, meeting client deliverables and improving operational efficiency.• Oversaw KPI management and performance of staff, supporting contracted FSP activities, maintaining compliance, and meeting client expectations.• Managed issue escalation and resolution, including developing corrective and preventive actions (CAPA), resulting in timely problem resolution and enhanced process reliability.

Kansas City Metropolitan Area

• Oversaw clinical research associate and clinical trial management staff performance management for FSP activities, ensuring technical proficiency and meeting client expectations by maintaining a high standard of skill and knowledge.• Managed compliance with client KPIs by utilizing tools to collect, track, and analyze data, ensuring accurate performance metrics and client satisfaction.• Led client-specific FSP meetings, monitoring contractual requirements and ensuring ongoing compliance with all client expectations and deliverables.• Managed issue escalation and CAPA development, ensuring timely resolution and implementing corrective actions to address issues in FSP Operations.• Coordinated the resourcing process, including hiring and onboarding staff and conducting performance reviews to maintain team effectiveness and alignment with organizational goals.

Kansas City Metropolitan Area

• Managed clinical trials and supporting staff, including clinical trial managers and clinical research associates, ensuring efficient trial execution across therapeutic groups and global clinical research organizations.• Performed quality assurance visits with assigned clinical research associate staff members.• Ensured team compliance with policies, SOPs, federal and local guidelines, and GCP standards, maintaining high regulatory adherence and monitoring compliance.• Client main point of contact, achieving high performance on assigned protocols and ensuring all project milestones were met.• Forecasted and assigned team needs, overseeing clinical research associate staff metrics, reviewing reports, tracking metrics, and managing essential documents to support efficient trial operations.• Coached and guided clinical trial managers, providing training and tools for successful study management and collaborating across teams to align company needs and support global business development strategies.

Kansas City Metropolitan Area

• Managed clinical research associate team working across therapeutic areas including oncology, neuroscience, cardiovascular-metabolic and infectious disease ensuring optimal project execution, resource allocation and adherence to clinical monitoring plan metrics and KPIs.• Performed quality assurance visits with assigned clinical research associate staff members.• Ensured compliance with policies, SOPs, federal and local guidelines, and GCP standards, maintaining regulatory adherence and addressing compliance issues promptly.• Identified and addressed performance and quality issues, implementing corrective actions and conducting follow-up to ensure resolution, resulting in improved project outcomes.• Tracked and reported departmental metrics and KPIs, providing data-driven insights for decision making and optimizing project performance.• Conducted new employee orientation and training, managed time and expenses for the team, interviewed talent for staffing needs, and led goal setting and career development for direct reports, fostering professional growth and team effectiveness.

Kansas City Metropolitan Area

• Assured adherence to good clinical practice (GCP), investigator integrity, and protocol compliance, maintaining exacting standards for clinical trial conduct.• Trained and managed clinical research associate team members, overseeing metrics including resourcing, trip report reviews, and finalization across various therapeutic areas, ensuring thorough and accurate reporting.• Led study start-up activities, including site feasibility, recruitment, and investigator meeting preparation, facilitating efficient study initiation and IP release.• Conducted site management and provided performance documentation, managing in-house and on-site monitoring activities and ensuring compliance with clinical monitoring, protocol deviation, medical monitoring, and TMF plans.• Negotiated and finalized site contracts and budgets and managed tracking systems during study start-up and progression, ensuring accurate financial and compliance documentation.

Kansas City Metropolitan Area

• Ensured adherence to good clinical practice (GCP), investigator integrity, and protocol compliance, maintaining rigorous standards in clinical trials.• Led study start-up activities, including site feasibility; recruitment; initiation, including smooth investigational product (IP) release and availability at assigned site(s); and interim monitoring visits, including laboratory quality assessment and IP accountability confirmation.• Performed clinical monitoring of Phases I-IV studies, open-label, dose escalation, and drug interaction protocols, delivering comprehensive study site support and mentorship.• Oversaw site management performance with screening, enrollment, and data entry timeliness per sponsor contract agreement.• Conducted regulatory reconciliation of study documentation, maintaining accurate records in both the site master file and TMF system.

Kansas City Metropolitan Area

• Ensured adherence to good clinical practice (GCP), FDA regulations, ICH guidelines, and IRB conditions, maintaining compliance with protocol and study procedures.• Delivered quality study monitoring according to client expectations and SOPs, specializing in therapeutic areas such as early-phase first-in-human, infectious disease, and neuroscience.• Provided oversight and mentorship to department colleagues, guiding clinical research associates in site management and performance documentation, including site qualification, initiation, interim monitoring, and closeout activities through see 1 do 1 protocol.• Facilitated and met sponsor-driven timelines, conducted ongoing site training, and ensured adherence to recruitment plans, completing monitoring reports within specified metric timelines.• Assured proper maintenance of study documentation in the site master file and TMF and oversaw investigational product reconciliation and destruction per sponsor directive, ensuring comprehensive regulatory compliance.

Doctor Of Chiropractic, Chiropractic

Bachelor Of Science - Bs, Social Work