Donna Rycroft

Donna Rycroft Email and Phone Number

Independent Consultant, Clinical Trial Management and Risk-based Quality Management @ Self Employed
Costa Mesa, CA, US
Donna Rycroft's Location
Costa Mesa, California, United States, United States
Donna Rycroft's Contact Details
About Donna Rycroft

Every day that I am able to spend coaching, collaborating or supporting innovative ideas is a fulfilling day.Innovative Leader- My passion for innovation has led to my contributions in the development of a Risk-based Quality Management, Issue Management System, Protocol Risk Assessment Tool, Strategic Global Start-up Initiative, Veeva Vault and Impact CTMS configuration and rollout.Risk-based Quality Managemetn Subject Matter Expert- My contributions include RBQM process development, implementation, company adoption of a novel model and development of risk assessment systems. Skilled Collaborator- My clinical research experience (20+ years) in project and people management across multiple therapeutic areas (Oncology, CNS, Gastroenterology, Aesthetics, Device, Infectious Disease, Respiratory, Urology) lends to my promotion of a collaborative, supportive environment which facilitates team contributions and innovative thinking.

Donna Rycroft's Current Company Details
Self Employed

Self Employed

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Independent Consultant, Clinical Trial Management and Risk-based Quality Management
Costa Mesa, CA, US
Donna Rycroft Work Experience Details
  • Self Employed
    Independent Consultant, Clinical Trial Management And Risk-Based Quality Management
    Self Employed
    Costa Mesa, Ca, Us
  • Abbvie
    Director, Study Risk Management
    Abbvie Feb 2022 - Present
    North Chicago, Illinois, Us
    • Responsible for the stand-up of the risk management center of excellence including expertise, tools and practices as part of the central monitoring and risk management team • Develops, manages, and mentors a team of Study Risk Leads• Responsible for the application of risk management practices in clinical programs in a dynamic environment ensuring compliance with quality standards and advancing study quality by systematically ensuring that a business risk lens is applied to clinical studies• Leads innovation/continuous improvement initiatives
  • Abbvie
    Director, Ta Lead Specialty, Global Site Management
    Abbvie May 2020 - Feb 2022
    North Chicago, Illinois, Us
    • Accountable for the global strategic and tactical planning and implementation of clinical programs for a therapeutic area including development and implementation of a multi-year strategy serving as a single point of TA accountability across all Clinical Site Management (CSM) globally.• Provide strategic direction, drives a learning environment, and ensures continuous improvement in organizational performance using innovative approaches, Key Performance Indicators (KPIs) and benchmarking to drive to achieve world class clinical execution. Ensures Clinical Field Operations and CSM business model is efficient and cost-effective vs alternative models.• Lead CSM risk-based quality management through active analysis of Key Risk Indicators/KPIs, metrics, and milestones; management of risk through development of mitigation plans• Provide leadership in Quality by Design by contributing to the development of formal risk management plans at the program and study levels; Ensure health authority inspection-readiness.• Provide line management to Global Site Management Leads• RBQM ambassador including AdaptiV steering committee member, SDR/SDV optimization initiative
  • Allergan
    Director, Global Site Management Operations
    Allergan Mar 2017 - May 2020
    Dublin, Coolock, Ie
    Responsible for strategizing, planning, directing and coordinating site management and monitoring activities. Accountable for all site management integrity, quality and timeliness of all monitoring activities. Responsible for Global Site Management Operations (GSMO) resourcing requirements, development of risk-based monitoring activities, risk assessment and mitigation, inspection readiness activities.Therapeutic Area Head (Gastroenterology, Device, Dermatology) for GSMO Program Leads providing line management, leadership, advisement and mentoring. Subject Matter expert for site management operations providing support to DDO cross-functional team members.Risk-based Monitoring Subject Matter expert in the development of SOPs, training and implementation of RBM processes across the DDO organization.Core team member in development and configuration of Impact CTMS, Veeva Vault start-up and Issue Management system.
  • Forest Laboratories (Now Allergan)
    Associate Director, Global Monitoring Operations
    Forest Laboratories (Now Allergan) Apr 2014 - Mar 2017
    Us
    Oversee the Global Monitoring Operations (GMO) across multiple projects for study execution (study planning to study completion). Responsibilities include Project management, resource allocation, technical oversight of processes and procedures, CRO management/oversight, implementation of Risk-based monitoring, management of GMO deliverables to include any aspects of site management from site selection to the closure of a site, management of study/site issue identification and risk mitigation, Cross-functional collaboration with clinical colleagues and senior management to ensure study deliverables are met across functional groups, training development and implementation (project and process specific) and Workstream contribution in process development.
  • Forest Laboratories (Now Allergan)
    Lead Senior Regional Site Manager
    Forest Laboratories (Now Allergan) Sep 2011 - Apr 2014
    Us
    Accountable for delivery of study and functional area goals through effect study management including patient recruitment, document management and data delivery according to program timelines.Primary contact and liaison between Program Lead and RSMs to ensure safety of subjects, accuracy of data and operational success. Collaboration with Program Lead and Clinical Team in development of study processes, templates and documents. Planning and coordination of RSM program training.
  • Kforce Clinical Research, Inc.
    Regional Clinical Research Associate /Abbott Laboratories
    Kforce Clinical Research, Inc. Nov 2009 - Sep 2011
    Raleigh, North Carolina, Us
    Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues.
  • Kforce Clinical Research, Inc.
    Clinical Research Site Manager/Pfizer Pharmaceuticals
    Kforce Clinical Research, Inc. Nov 2007 - Nov 2009
    Raleigh, North Carolina, Us
    Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues.
  • Loma Linda University Cancer Institute
    Research Nurse, Program Supervisor
    Loma Linda University Cancer Institute Aug 1999 - Nov 2007
    Manage the pediatric oncology research program and staff members ensuring the accuracy and conduct of all clinical studies, regulatory submissions, study enrollments, case report submissions and toxicity reporting.
  • Loma Linda University Medical Center
    Clinical Staff Nurse, Relief Charge Nurse, Quality Improvement Coordinator
    Loma Linda University Medical Center Aug 1995 - Aug 1999
    Loma Linda, Ca, Us

Donna Rycroft Skills

Oncology Pharmaceutical Industry Clinical Monitoring Gcp Infectious Diseases Clinical Trials Clinical Research Ich Gcp Ctms Protocol Therapeutic Areas Edc Cro Central Nervous System Regulatory Submissions Asthma Clinical Development Cns

Donna Rycroft Education Details

  • California State University-San Bernardino
    California State University-San Bernardino
    Nursing

Frequently Asked Questions about Donna Rycroft

What company does Donna Rycroft work for?

Donna Rycroft works for Self Employed

What is Donna Rycroft's role at the current company?

Donna Rycroft's current role is Independent Consultant, Clinical Trial Management and Risk-based Quality Management.

What is Donna Rycroft's email address?

Donna Rycroft's email address is ry****@****gan.com

What schools did Donna Rycroft attend?

Donna Rycroft attended California State University-San Bernardino.

What skills is Donna Rycroft known for?

Donna Rycroft has skills like Oncology, Pharmaceutical Industry, Clinical Monitoring, Gcp, Infectious Diseases, Clinical Trials, Clinical Research, Ich Gcp, Ctms, Protocol, Therapeutic Areas, Edc.

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