Kristin Bobbitt-O’Malley Email and Phone Number
Ms. Bobbitt-O'Malley is a Director of Clinical Operations at Premier Research, a leading CRO that provides clinical development services to biotech and specialty pharma companies. With over 20 years of experience in the CRO industry, Bobbitt-O'Malley has a solid background in clinical monitoring management, process improvement, and customer partnerships, delivering operational, financial, and quality outcomes for various clinical trials.In addition, Ms. Bobbitt-O'Malley has extensive expertise in multiple therapeutic areas, including cardiology, endocrinology, neurology, oncology, and medical device, working with large pharma, biotech, and small pharma clients across all phases of clinical development. Bobbitt-O'Malley has also established and developed a global team of clinical site associates and centralized report review specialists, ensuring their growth, development, and performance. Bobbitt-O'Malley's mission is to provide innovative and flexible solutions that meet the needs and expectations of the clients and the patients.
Allucent
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Sr. Director Clinical OperationsAllucent Apr 2024 - PresentUnited States -
Director Of Clinical Operations, Functional ServicesPremier Research Nov 2023 - Present -
Associate Director, Clinical MonitoringIqvia Aug 2019 - May 2022Chapel Hill, North Carolina, United StatesNovella was acquired by Quintiles in 2013 and was rebranded as IQVIA Biotech in 2019.Responsible for the growth, development, and maintenance of the Global Central Monitoring Team for IQVIA Biotech which consisted of 5 managers, 70+ Clinical Site Associates and 11 Site Report Specialists. In addition, served as a key member of the Clinical Monitoring Leadership team, working in partnership with key team members of other Functional Areas within Biotech (as needed) to set the strategy… Show more Novella was acquired by Quintiles in 2013 and was rebranded as IQVIA Biotech in 2019.Responsible for the growth, development, and maintenance of the Global Central Monitoring Team for IQVIA Biotech which consisted of 5 managers, 70+ Clinical Site Associates and 11 Site Report Specialists. In addition, served as a key member of the Clinical Monitoring Leadership team, working in partnership with key team members of other Functional Areas within Biotech (as needed) to set the strategy and direction for the department. Show less -
Senior Manager Clinical OperationsIqvia Aug 2017 - Aug 2019Raleigh-Durham-Chapel Hill AreaNovella was acquired by Quintiles in 2013 and was rebranded as IQVIA Biotech in 2019.Established and developed a team of CSAs (Clinical Site Associates - in-house CRAs / Centralized Monitoring Team) and Centralized Report Review Specialists in India.Responsible for line management and technical support for 15 direct reports including CRAs, CTLs, and CSAs, ensuring operational, financial, and quality delivery. Assisted Clinical Operations Management with review and revision of… Show more Novella was acquired by Quintiles in 2013 and was rebranded as IQVIA Biotech in 2019.Established and developed a team of CSAs (Clinical Site Associates - in-house CRAs / Centralized Monitoring Team) and Centralized Report Review Specialists in India.Responsible for line management and technical support for 15 direct reports including CRAs, CTLs, and CSAs, ensuring operational, financial, and quality delivery. Assisted Clinical Operations Management with review and revision of department SOPs, working practices, and policies. Also participated in development and implementation of process improvement plans while collaborating cross functionally to ensure consistency of process. Served as CTM (Clinical Trial Manager) and CRA for projects as needed. Show less -
Manager Clinical OperationsNovella Clinical Dec 2015 - Aug 2017Raleigh-Durham-Chapel Hill AreaLine management and technical support for assigned team of CRAs, CTLs, and CSAs, ensuring operational, financial, and quality delivery. Assisted Clinical Operations Management with review and revision of department SOPs, working practices, and policies. Provided support to various Process Improvement Initiatives.Novella was acquired by Quintiles in 2013 and was rebranded as IQVIA Biotech in 2019. -
Associate Director, Therapeutic Delivery SolutionsQuintilesims Jan 2014 - Dec 2015Durham, North Carolina -
Associate Director, Integrated Processes And TechnologyQuintilesims Jan 2013 - Dec 2013Helped develop Quintiles strategy for Risk Bases Monitoring -
Associate Director, Global Clinical Office Of Quality ManagementQuintilesims Sep 2010 - Dec 2012 -
Stay At Home MomSelf Jun 2009 - Sep 2010
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Associate Global Operations DirectorQuintilesims Oct 2008 - Jun 2009Raleigh-Durham-Chapel Hill AreaSupported strategic planning, direction, and support of the portfolio for an assigned customer where Quintiles was the Preferred Provider. Provided oversight to the clinical project teams assigned to the customer portfolio and helped manage project delivery against key account metrics, milestones, and contractual obligations for portfolio of projects. Also acted as relationship manager for designated customer including escalation and client management needs as well as a member of the Alliance… Show more Supported strategic planning, direction, and support of the portfolio for an assigned customer where Quintiles was the Preferred Provider. Provided oversight to the clinical project teams assigned to the customer portfolio and helped manage project delivery against key account metrics, milestones, and contractual obligations for portfolio of projects. Also acted as relationship manager for designated customer including escalation and client management needs as well as a member of the Alliance Governance Committees. Show less -
Manager, Clinical OperationsIqvia Apr 2006 - Sep 2007Raleigh-Durham-Chapel Hill Area -
Associate Clinical ScientistIqvia Aug 2003 - Oct 2004Raleigh-Durham-Chapel Hill AreaAccountable for planning and delivery of the clinical component of large, complex protocols and global projects in accordance with the scope of work, contracted timelines, and budgets. Coordinated efforts for multi-operational projects while providing technical and scientific input into study design, protocol, CRF, and informed consent development. Provided clinical research expertise, site monitor leadership, and management of clinical monitoring activities. Developed project specific… Show more Accountable for planning and delivery of the clinical component of large, complex protocols and global projects in accordance with the scope of work, contracted timelines, and budgets. Coordinated efforts for multi-operational projects while providing technical and scientific input into study design, protocol, CRF, and informed consent development. Provided clinical research expertise, site monitor leadership, and management of clinical monitoring activities. Developed project specific procedures and work instructions for all assigned clinical monitoring staff. Show less -
Senior Clinical Research Associate / Clinical Team LeadIqvia May 2002 - Aug 2003Raleigh-Durham-Chapel Hill AreaServed as Clinical Team Lead for global and multi-region studies while maintaining contact with study sponsors. Provided oversight for study progress, clinical budget, timelines, and deliverables. Developed project specific training for CRAs and mentored new CRAs within the organization. -
Clinical Research AssociateQuintilesims Aug 2000 - Aug 2002Raleigh-Durham-Chapel Hill Area -
Clinical Trial AssistantQuintilesims Jun 1998 - Aug 2000Raleigh-Durham-Chapel Hill Area -
ManagerGap Nov 1997 - May 1998Raleigh, North Carolina, United States -
Commission Sales AssociateAnn Inc (Ann Taylor | Loft | Lou & Grey) Jun 1997 - Nov 1997Orlando, Florida, United States -
Outdoor FoodsThe Walt Disney Company Jan 1997 - May 1997Orlando, Florida, United StatesWorked in the Disney College Program at Epcot in Outdoor Foods. The Disney College program is a semester-long paid work experience. Attended classes at Disney University. Received multiple Customer Experience awards and participated in Voice of the Customer presentations.
Kristin Bobbitt-O’Malley Education Details
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Biology
Frequently Asked Questions about Kristin Bobbitt-O’Malley
What company does Kristin Bobbitt-O’Malley work for?
Kristin Bobbitt-O’Malley works for Allucent
What is Kristin Bobbitt-O’Malley's role at the current company?
Kristin Bobbitt-O’Malley's current role is Experienced Clinical Research Leader with Global CRO experience with Pharma and Biotech.
What schools did Kristin Bobbitt-O’Malley attend?
Kristin Bobbitt-O’Malley attended Elon University.
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