Kristin Bobbitt-O’Malley

Kristin Bobbitt-O’Malley Email and Phone Number

Experienced Clinical Research Leader with Global CRO experience with Pharma and Biotech @ Allucent
Kristin Bobbitt-O’Malley's Location
Chapel Hill, North Carolina, United States, United States
About Kristin Bobbitt-O’Malley

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.

Kristin Bobbitt-O’Malley's Current Company Details
Allucent

Allucent

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Experienced Clinical Research Leader with Global CRO experience with Pharma and Biotech
Kristin Bobbitt-O’Malley Work Experience Details
  • Allucent
    Sr. Director Clinical Operations
    Allucent Apr 2024 - Present
    United States
  • Premier Research
    Director Of Clinical Operations, Functional Services
    Premier Research Nov 2023 - Present
  • Iqvia
    Associate Director, Clinical Monitoring
    Iqvia Aug 2019 - May 2022
    Chapel Hill, North Carolina, United States
    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… 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
  • Iqvia
    Senior Manager Clinical Operations
    Iqvia Aug 2017 - Aug 2019
    Raleigh-Durham-Chapel Hill Area
    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… 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
  • Novella Clinical
    Manager Clinical Operations
    Novella Clinical Dec 2015 - Aug 2017
    Raleigh-Durham-Chapel Hill Area
    Line 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.
  • Quintilesims
    Associate Director, Therapeutic Delivery Solutions
    Quintilesims Jan 2014 - Dec 2015
    Durham, North Carolina
  • Quintilesims
    Associate Director, Integrated Processes And Technology
    Quintilesims Jan 2013 - Dec 2013
    Helped develop Quintiles strategy for Risk Bases Monitoring
  • Quintilesims
    Associate Director, Global Clinical Office Of Quality Management
    Quintilesims Sep 2010 - Dec 2012
  • Self
    Stay At Home Mom
    Self Jun 2009 - Sep 2010
  • Quintilesims
    Associate Global Operations Director
    Quintilesims Oct 2008 - Jun 2009
    Raleigh-Durham-Chapel Hill Area
    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… 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
  • Iqvia
    Manager, Clinical Operations
    Iqvia Apr 2006 - Sep 2007
    Raleigh-Durham-Chapel Hill Area
  • Iqvia
    Associate Clinical Scientist
    Iqvia Aug 2003 - Oct 2004
    Raleigh-Durham-Chapel Hill Area
    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… 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
  • Iqvia
    Senior Clinical Research Associate / Clinical Team Lead
    Iqvia May 2002 - Aug 2003
    Raleigh-Durham-Chapel Hill Area
    Served 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.
  • Quintilesims
    Clinical Research Associate
    Quintilesims Aug 2000 - Aug 2002
    Raleigh-Durham-Chapel Hill Area
  • Quintilesims
    Clinical Trial Assistant
    Quintilesims Jun 1998 - Aug 2000
    Raleigh-Durham-Chapel Hill Area
  • Gap
    Manager
    Gap Nov 1997 - May 1998
    Raleigh, North Carolina, United States
  • Ann Inc (Ann Taylor | Loft | Lou & Grey)
    Commission Sales Associate
    Ann Inc (Ann Taylor | Loft | Lou & Grey) Jun 1997 - Nov 1997
    Orlando, Florida, United States
  • The Walt Disney Company
    Outdoor Foods
    The Walt Disney Company Jan 1997 - May 1997
    Orlando, Florida, United States
    Worked 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

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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