Kristin Bobbitt-O’Malley

• Reports to the President of Global Clinical Trial Operations (Global Clinical Trial full-service functional teams supporting project delivery – Project Management, Clinical Operations, Data Management, Site Start-up, Site, and Patient Engagement, etc.).
• Establish and drive the Global Clinical Team Lead (GCTL) department structure and delivery approach in support of Allucent’s project portfolio delivery, in accordance with the newly established clinical delivery strategy.
• Reorganize and align the GCTL Management team according to the current Global Clinical Operations (GCO; specifically, the Global CTL Team and their management and support) structure and strategy within Allucent’s Global Clinical Trial Operations (GCTO) organizational structure, and support of companywide 'Must-Win Initiatives.'
• Develop a strategy, related KPIs, and processes to support Allucent's Must-Win Initiatives.
• Manage Global CTL resources to support business needs, forecasting for future and awarded opportunities, including global recruitment activities in partnership with the Global Talent Acquisition Team.
• Responsible for the review and development of, including ongoing updates to GCO SOPs, in alignment with other functional groups.
• Establish updated roles and responsibilities, and up-skilling of GCO team members (CTLs, CRAs, and CTAs) as related to the Allucent strategy versus legacy organizations (relating to prior mergers and acquisitions).
• Manage GCO project escalations and customer support, quality, and timely delivery of projects in accordance with project-specific SoWs, timelines, and related milestones, as well as ensuring overall customer satisfaction.
• Partner with Business Development in support of customers and related business opportunities. Including updates to the current costing tool and supporting algorithms to ensure accurate RFP responses and project costing in support of Allucent's financial goals.
• Establish and deliver role-specific training. Ensure best practices, lessons learned, and standardized processes are included in these trainings, as well as supporting tools and role-specific job aids.
• CTMS: Veeva.

• Responsible for the oversight of recruitment and line management of Clinical Operations staff, including staff resourcing, communicating job expectations, planning, monitoring, and appraising job results, coaching, and counseling employees, and developing, coordinating, and enforcing policies, procedures, and productivity standards to ensure high performance.
• Works with the management team to ensure quality and customer service, analyzing and resolving quality and customer service problems, identifying trends, and recommending system improvements.
• Build and maintain long-term rapport and strategic relationships with customers to ensure that their expectations are continuously exceeded.
• Analyzed customer feedback data to identify trends in team performance or customer service issues.
• Examine, evaluate, and remediate the department’s process to identify shortfalls and bottlenecks.
• Develop plans and processes that reset the bar at a higher level and move past organic or incremental improvements as the measure of success.
• Implemented systems for tracking progress on key initiatives or projects.
• Developed performance metrics for employee evaluation aligned with contractual benchmarks.
  Performed assessments of staff against established targets to identify areas for improvement.
• Reviewed metrics regularly to promote ongoing enhancement of performance standards.
  Facilitated continuous improvement by evaluating employee output systematically.
• Supports business development activities by taking ownership of project costing estimates, proposal reviews, change order management, and proposal defenses.
• Manages the resource allocation and utilization for their team in conjunction with the project goals for the department.
• Administers financial compensation for direct reports, and proposes adjustments (e.g., promotions, market adjustments, etc.).
• Represented the organization at industry conferences.
• CTMS: Veeva CTMS, Veeva eDC.

• Established and managed Global Central Monitoring Team consisting of five managers, 75 Clinical Site Associates, and 11 Site Report Specialists.
• Directed all phases of study design, planning, and execution, including budgeting, risk assessment, and data review.
• Developed training programs for existing staff members as well as new hires.
• Developed and implemented strategies to increase organizational effectiveness and efficiency.
• Oversaw day-to-day operations of the organization including personnel management, program development and implementation.
• Collaborated with Clinical Monitoring Leadership team to define departmental strategy and direction.
• Analyzed data collected from various sources in order to identify trends or areas requiring further investigation or action.
• Developed and implemented process improvement plans to enhance operational efficiency.
• Led and drove collaboration with internal teams and partners to meet expected timelines, budget and quality standards.
• Maintained positive relationships with cross-functional leadership by responding promptly to inquiries, requests, and complaints.
• Coordinated with other functional areas to ensure the successful completion of projects within established timelines and budgets.
• Executed role of Clinical Trial Manager and Clinical Research Associate for various projects as required.
• Supported proposal preparations and bid defenses to secure project opportunities.
• CTMS: in-house.

• Directed line management and technical support for 15 direct reports, achieving operational excellence.
• Established and developed teams of CSAs and Centralized Report Review Specialists in India.
• Collaborated across departments to create standardized processes.
• Assisted Clinical Operations Management in revising department SOPs and policies.
• Contributed to development and implementation of process improvement plans.
• Served as Clinical Trial Manager and CRA for various projects as needed.
• Ensured financial performance and quality delivery through effective oversight of CRAs, CTLs, and CSAs.
• Participated in continuous initiatives to enhance operational efficiency.
• CTMS: in-house.

• Transitioned to Novella during Quintiles' acquisition.
• Delivered line management and technical support for team of CRAs, CTLs, and CSAs to ensure quality outcomes.
• Ensured compliance with ICH/GCP requirements, industry standards, protocol, and scope of work, as well as company SOPs across all operations.
• Collaborated with Clinical Operations Management to review and update department SOPs and policies.
• Provided leadership to direct and indirect reports amidst organizational changes.
• CTMS: in-house.

• Managed line operations and provided technical support for Clinical Leads, ensuring optimal financial and quality delivery.
• Collaborated across functions to create integrated project plans, maintaining accountability for assigned team outcomes.
• Partnered with various departments to guarantee achievement of project milestones and deliverables.
• Led a cross-functional team to review, update, redesign, and consolidate enterprise-wide SOPs, enhancing efficiency.
• Reduced number of Clinical Operations SOPs by 20% through assessment and realignment initiatives.
• Partnered with Quality Assurance in facilitating the identification, development, and closure of CAPA actions within projects, across functions, enterprise wide.

• Developed and updated SOPs for various cross-functional teams to ensure compliance with process and regional / country-specific regulatory requirements, as well as ICH / GCP.
• Acted as Global Clinical Liaison for initial projects implementing Risk Based Monitoring strategies.
• Contributed as a Global Clinical representative in the development of a data-driven trial execution solution (Risk-Based Monitoring / Risk-Based Quality Management).
• Created tools and processes to enhance DTE implementation (RBM: Risk-Based Monitoring / RBQM: Risk-Based Quality Management).
• Facilitated cross functional change management and adoption of DTE with a focus on Global Clinical Operations (RBM / RBQM).
• CTMS: Oracle's Siebel Clinical Trial Management System.

• SOP management, including creating, organizing, and maintaining standard operating procedures (SOPs), is essential to ensure consistent and efficient execution of clinical monitoring and management of project work.
• Conducted risk assessments for projects completed from 2005 to 2010 to identify potential risks.
• Collaborated with cross-functional leaders (Quality Assurance, Project Management, Clinical Operations, and Sr. Leadership) to develop strategies minimizing impact of identified risks.
• CTMS: Oracle’s Siebel Clinical Trial Management System.

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• Supported strategic planning and direction for customer portfolio as preferred provider.
• Oversaw clinical project teams, ensuring project delivery met key metrics and milestones.
• Managed client relationships, addressing escalations and maintaining effective communication.
• Facilitated communication between stakeholders at all levels of the customer and Quintiles' organization.
• Managed daily operations, ensuring compliance with quality standards, safety regulations, and legal requirements.
• Resolved customer complaints promptly and professionally.
• Provided guidance and support to team members while ensuring that they adhere to established standards.
• Ensured that all regulatory requirements were met by conducting regular inspections of facilities and equipment.
• Assure the Clinical Operations team assigned to the customer's projects managed and ensured the quality and integrity of the electronic Trial Master File (eTMF), and inspection readiness.
• Participated in Alliance Governance Committees to enhance collaboration and decision-making.
• CTMS: in-house and Oracle’s Siebel Clinical Trial Management System.

Global Process Optimization (Apr. 2006 - Sep. 2008)

• Optimized customer account operations by collaborating closely with Global Operations Head and executives at all levels.
• Analyzed and provided strategic responses to multiple Six Sigma projects.
• Designed and implemented enterprise-wide metrics for improved performance evaluation.
• Redesigned corporate visit reports to enhance clarity and adherence to completion timelines.

Manager Clinical Operations (Sep. 2004 - Mar. 2006)

• Oversaw Clinical Team Leads, Clinical Research Associates, and Clinical Trial Assistants, emphasizing training and development.
• Ensured compliance with regulatory guidelines (ICH / GCP), protocols, and company policies by fostering a culture of compliance by equipping team with necessary resources and training
• Monitored workload and quality metrics to achieve performance objectives.
• Conducted regular performance meetings with team members to identify improvement areas and provide coaching.
• Facilitated collaboration between direct reports and other departments to resolve project-related challenges.
• Participated in quality assurance initiatives to enhance clinical trial processes.
• Collaborated with Quality Assurance and Data Protection and Privacy teams on suspected compliance issues.
• CTMS: in-house.

• Directed planning and implementation of clinical components for large-scale, complex protocols.
• Ensured adherence to all relevant regulations and guidelines (ICH / GCP), scope of work, timelines, budgets, and compliance for clinical trial data.
• Coordinated cross-functional teams for multi-operational projects, contributing technical and scientific expertise.
• Developed project-specific procedures and work instructions for clinical monitoring staff.
• Designed recruitment strategies for new patients in clinical trials.
• Managed multiple projects simultaneously under tight deadlines in fast-paced environments.
• Reviewed clinical data listings for accuracy and consistency, generating queries to resolve discrepancies.

• Managed the Clinical Team and provided oversight for international and multi-region studies, monitoring progress, clinical budget, timelines, and deliverables, while engaging with study sponsors.
• Reviewed and provided input on study-specific protocols, case report forms, and other study documents for accuracy.
• Collaborated with Clinical Data Management and other cross-functional teams to establish project-specific processes and tools, including CRF development, data validation, and logic checks, etc.
• Developed and provided project-specific training for project-assigned resources (CRAs and CTAs), as well as sites and site staff.
• Developed or assisted in the development of study-specific documents, templates, and monitoring tools (informed consent, guidance documents, clinical project plans, project-specific work instructions, etc.) according to local regulations.
• Investigational Product (IP) management.
• Organized investigator meetings; prepared meeting minutes and tracked action items arising from these meetings.
• Participated in / chaired regular conference calls with sponsor representatives, clinical team members, site study coordinators, and investigators.
• Ensured submission compliance of site monitoring visit reports, reviewed and approved for quality, and prepared reports summarizing findings from monitoring visits.
• Maintained accurate documentation of all on-site activities in the trial master file.
• Provided support to internal audit teams conducting audits at investigative sites.
• Provided guidance, training, and mentoring of junior and newly hired clinical research associates regarding protocol adherence, CRF completion, and other aspects of the clinical trial process.
• Engaged the assigned project team members' line managers as necessary.
• Liaised with Quality Assurance as needed for any suspected fraud or noncompliance.
• CTMS: in-house.

• Conducted oversight of Phase I-III studies in compliance with FDA, ICH, and GCP regulations.
• Executed comprehensive monitoring visits, including initiation, interim, close-out, and booster assessments.
• Performed source document verification and reviewed project documentation for accuracy; generated and resolved queries.
• Achieved approximately 80% SDV currency across assigned sites throughout study duration.
• Collaborated with sponsors, CROs, investigators, vendors, and subcontractors to ensure study success.
• Monitored safety events reported during clinical trials in accordance with SOPs.
• Ensured proper storage of investigational products at investigator sites per GCP guidelines.
• Tracked enrollment status across multiple sites to achieve target goals efficiently.

• Communicated effectively with external stakeholders such as sponsors, CROs, vendors.
• Prepared submissions for Institutional Review Board or Ethics Committee approval, amendments, renewals.
• Assisted with the preparation for internal and site-level inspections.
• Responded promptly to queries from investigators regarding protocol procedures or other issues related to the conduct of a clinical trial.
• Coordinated shipment of study materials between sponsors, investigators, vendors.
• Provided support for all aspects of the clinical trial process including recruitment, data collection, and closeout activities.
• Performed a second scrub of CRF data via Q-Star, reviewed data listings, and reviewed and resolved queries for assigned project sites (15 sites).
• Ensured timely completion of essential documents by investigators and research staff.
• Maintained regulatory documents such as informed consent forms and investigator brochures.
• Tracked subject enrollment status, screening results, adverse events, concomitant medications.
• Generated reports summarizing patient safety information collected during a clinical trial.
• Collaborated with internal teams on project timelines and deliverables.
• Performed data entry into electronic databases for tracking purposes.
• Supported CRAs, project managers, clinical team leads, and other clinical operations staff with in-house monitoring activities.
• Updated and maintained the CTMS (in-house).
• Regulatory document review and tracking.
• Generation of client-specific reports.
• Resolution of site issues, and Data Clarification Form review and resolution.
• Co-monitoring, depending on project and site needs.