Kimberly Malone
Senior Director, Clinical Operations at FHI Clinical Inc.- Claim this Profile
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Bio
LinkedIn User
I have worked with Kimberly in different capacities - once when she was a trainer and I was at another company, and most recently we worked together in operational optimization. Kimberly is a caring leader, consistently showing dedication and enthusiasm. I always appreciated her openness to discuss "out the box" ideas and warm nature.
LinkedIn User
I have worked with Kimberly in different capacities - once when she was a trainer and I was at another company, and most recently we worked together in operational optimization. Kimberly is a caring leader, consistently showing dedication and enthusiasm. I always appreciated her openness to discuss "out the box" ideas and warm nature.
LinkedIn User
I have worked with Kimberly in different capacities - once when she was a trainer and I was at another company, and most recently we worked together in operational optimization. Kimberly is a caring leader, consistently showing dedication and enthusiasm. I always appreciated her openness to discuss "out the box" ideas and warm nature.
LinkedIn User
I have worked with Kimberly in different capacities - once when she was a trainer and I was at another company, and most recently we worked together in operational optimization. Kimberly is a caring leader, consistently showing dedication and enthusiasm. I always appreciated her openness to discuss "out the box" ideas and warm nature.
Credentials
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LEAN Facilitator
IQVIAJan, 2021- Nov, 2024 -
Senior Professional in Human Resources® (SPHR®) Certification
HRCIDec, 2014- Nov, 2024
Experience
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FHI Clinical Inc.
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Senior Director, Clinical Operations
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Nov 2022 - Present
Responsible for setting the overall direction, strategy, and performance standards for Project Management, Site Management and Study Startup departments. Leads and mentors the clinical team, maintaining the appropriate resources while ensuring adherence to quality management practices. Provides oversight of a portfolio of trials to ensure high-quality services are delivered on time and within scope and budget. Responsible for setting the overall direction, strategy, and performance standards for Project Management, Site Management and Study Startup departments. Leads and mentors the clinical team, maintaining the appropriate resources while ensuring adherence to quality management practices. Provides oversight of a portfolio of trials to ensure high-quality services are delivered on time and within scope and budget.
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IQVIA Biotech
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Durham, North Carolina, United States
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Sr. Director, Operational Optimization
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Mar 2017 - Nov 2022
Implemented LEAN program for IQVIA Biotech | Facilitated LEAN Kaizen multi‐day events across multiple functional areas; Faculty Advisor for IQVIA LEAN Facilitator Trainings | Led corporate wide initiatives including: implement new corporate pricing tool; deploy new eTMF system and migrate studies from legacy system; implement corporate and project level key performance indicators for TMF Inspection Readiness Implemented LEAN program for IQVIA Biotech | Facilitated LEAN Kaizen multi‐day events across multiple functional areas; Faculty Advisor for IQVIA LEAN Facilitator Trainings | Led corporate wide initiatives including: implement new corporate pricing tool; deploy new eTMF system and migrate studies from legacy system; implement corporate and project level key performance indicators for TMF Inspection Readiness
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Novella Clinical
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Global Head, HR and Training
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Mar 2011 - Mar 2017
Managed the acquisition of Novella Clinical by Quintiles/IQVIA, including corporate change management and communication, resulting in stable retention | Implemented development programs for staff at all levels including: personal accountability, customer service, leadership, and collaboration
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Manager / Director, eProcess Integration and Training
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Apr 1999 - Feb 2011
Implemented Electronic Data Capture (EDC) for several major pharmaceutical clients in both developed and resource limited countries. While onsite in rural sites in Asia and Africa, conducted hands on EDC training for site staff in Ghana, Kenya, Bangladesh, and Vietnam. Worked through technical and process challenges due to remote location of sites in Ghana and Bangladesh.
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GlaxoSmithKline Consumer Healthcare, L.P.
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United States
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Clinical Research Scientist
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May 1997 - Mar 1999
Performed project management and clinical research activities in support of a multiple protocol, international HIV program; Wrote IND Annual Report; Assisted in writing Clinical Study Reports and Integrated Safety Summary for submission in the New Drug Application for the protease inhibitor Amprenavir to the FDA. Performed project management and clinical research activities in support of a multiple protocol, international HIV program; Wrote IND Annual Report; Assisted in writing Clinical Study Reports and Integrated Safety Summary for submission in the New Drug Application for the protease inhibitor Amprenavir to the FDA.
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ClinTrials Research, Inc - CRO
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Durham, NC
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CRA/Sr. CRA/CRA Trainer/Training Manager
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Jun 1993 - May 1997
Designed and implemented an ongoing eight (8) day CRA Training Program across all Clinical Monitoring locations in North and South America | Managed and led clinical aspects of studies | Conducted study startup activities, regulatory document review, SEVs, SIVs, IMVs, COVs | Therapeutic Areas include Infectious Disease, CNS - Epilepsy, Gastroenterology. Designed and implemented an ongoing eight (8) day CRA Training Program across all Clinical Monitoring locations in North and South America | Managed and led clinical aspects of studies | Conducted study startup activities, regulatory document review, SEVs, SIVs, IMVs, COVs | Therapeutic Areas include Infectious Disease, CNS - Epilepsy, Gastroenterology.
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UNC Hospitals
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United States
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Hospitals and Health Care
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100 - 200 Employee
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Research Study Coordinator
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Feb 1990 - May 1993
Conducted patient recruitment, neuropsychological testing, stress interviews, HIV pre- and post-test counseling for 250 study participants in a study funded by the National Institute of Mental Health. Conducted patient recruitment, neuropsychological testing, stress interviews, HIV pre- and post-test counseling for 250 study participants in a study funded by the National Institute of Mental Health.
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Education
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Duke University
Bachelor's degree -
NC School of Science and Mathematics
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