Kristin Bobbitt-O’Malley Email & Phone Number

United States

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

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

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.

Durham, North Carolina

Helped develop Quintiles strategy for Risk Bases Monitoring

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

Raleigh-Durham-Chapel Hill Area

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

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.

Raleigh-Durham-Chapel Hill Area

Raleigh-Durham-Chapel Hill Area

Raleigh, North Carolina, United States

Orlando, Florida, United States

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.