Lee Ferrell Email & Phone Number

Durham, Nc, Us

Research Triangle Park, Nc, Usa

Research Triangle Park, Nc, Usa

Key Responsibilities: Direct and manage an assigned team of Clinical Lead Management and staff who manage or support studies or programs to ensure clinical deliverables are met to the Sponsor’s satisfaction. Work with staff to ensure that all study management and clinical deliverables are completed to the Sponsor’s satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices. Ensure that employees are trained and individual development is aligned and in place to meet project and organizational needs.

Research Triangle Park, Nc, Usa

Key Responsibilities: Operational Management of Global Regulatory and Start UpGlobal Oversight of Identified Key Accounts Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.Direct the hiring and selection process for a function/region/country or office and work collaboratively with senior management to set targets for recruitment and retention across roles.Contribute to the formulation of effective strategic goals for operations across regions/countries. Take ownership for strategic initiatives within assigned unit of accountability including development of measures for success.Provide leadership to ensure all service offerings meet or exceed customer expectations. Ensure the improvement of the execution of processes.Manage operational delivery to achieve outputs to pre-defined targets.Contribute to the provision of strategic leadership and approval for the resourcing process and outcomes, hiring targets and processes and onboarding and training standards.

Research Triangle Park, Nc, Usa

Key Responsibilities: Operational Management of Regulatory and Start UpProject planningDevelopment of processes and role responsibilitiesRecruitment/work analysis forecastingProject issue escalation and resolution

Research Triangle Park, North Carolina, Usa

Key Responsibilities: Oversees the running of the department, helps minimize the learning curve of new staff within department or ad hoc members coming in as part of new project initiatives.Management responsibilities include professional development, performance appraisals, and employee counseling for junior staff. Assigns project work and reviews workload for all direct reports. Manages staff by assigning them with their responsibilities when necessary, establishing goals that will increase knowledge and skill levels, and delegating tasks commensurate with skill level.Approves courses of action on all management / human resources’ matters, including salary administration, transfers, hiring, terminations, professional development, performance appraisals, position description preparation, and employee counseling.Assists in formulating effective strategic goals and objectives for department and ensures implementation and operational integration of those goals and objectives as directed by senior management.Takes ownership of strategic initiatives and works with other functional management to develop implementation plans, including measures to evaluate site start up success.Provides assistance in the development, enhancement and maintenance of data systems, to provide data output contained within said systems and assists in performing data analysis.Maintains appropriate base staffing within the department.Responsible for facilitating the utilization of enhancements, innovations, successes across teams.Ensures adherence to all processes within the department as outlined and assesses workloads.Sets metrics based on deliverables from department in terms of cost, quality and productivity.Reports progress of department to senior management

Research Triangle Park, North Carolina, Usa

Key Responsibilities: Management responsibilities include professional development, performance appraisals, and employee counseling for junior staff. Assigns project work and reviews workload for all direct reports. Manages staff by assigning them with their responsibilities when necessary, establishing goals that will increase knowledge and skill levels, and delegating tasks commensurate with skill level.Recommends courses of action on all management / human resources’ matters, including salary administration, transfers, hiring, terminations, professional development, performance appraisals, position description preparation, and employee counseling.Takes ownership of strategic initiatives and works with other functional management to develop implementation plans, including measures to continually evaluate site start up success, and roll-out to other officesMeets with various internal contacts upon project award (and as necessary thereafter) to determine operational strategy/expectations and parameters for review/negotiation of contracts and regulatory documents.Works with sponsors and internal team members to establish boilerplate documents necessary for startup (including confidential disclosure agreements, Site Interest Forms, and contracts).Ensures overall departmental efficiency and adherence to project timelines.Meets or exceeds staff utilization and realization targets.Assists Business Services with proposal review and budget development, including continual assessment of the accuracy of budget.Liaises with customers to ensure operational efficiency.Develops site performance metrics.Develops systems improvements in conjunction with IT.Ensures adherence by staff to Standard Operating Procedures, Work Instructions, and Project Instructions.Identifies and resolves ongoing training and development needs of staff.Leads training/orientation of department staff in other locations.

Research Triangle Park, North Carolia, Usa

Key Responsibilities: Primary responsibility is to manage a group of clinical staff and provides in-house and on-site mentoring in the following areas as required: a)Site selection including identification of investigators, site selection visits and budget negotiation. b) Site initiation ensuring completion of regulatory documents, study file set up and co-ordination of study materials. c)Periodic study monitoring including on-site visits to ensure protocol and GCP adherence, resolving site issues, reviewing CRFs, source documents, data queries and all required communications to ensure monitoring is being conducted in accordance with required Quintiles/Sponsor SOPs and any national regulations. d) Study termination including resolving all outstanding data queries andreviewing record retention requirements.Supervises Administrative Assistants, Clinical Assistants, Sr. Clinical Assistants, CRAs, Sr. CRAs, Clinical Project Specialists and Sr. Clinical Project Specialists, and Associate Managers as needed.Allocates local or assigned monitoring resources, participates in HR hiring process including review of potential candidates and interviewing process.Participates in development of clinical portion of client proposals including the budgeting process.Participates in marketing activities, client presentations and proposal development.

Research Triangle Park, North Carolina, Usa

Key Responsibilities: Provided clinical research expertise, site monitor leadership and management of clinical monitoring activities for all types of clinical trials.Responsible for the planning and delivery of the clinical component of the project in accordance with the scope of work and contracted timelines, and for managing the clinical portion of the study budget.Served as a Clinical Project Advisor and/or Clinical Team Leader for a multi-operational project of low or medium complexity, a regional Lead

Raleigh-Durham, North Carolina Area

Durham North Carolina United States

I provide senior oversight for management of resources, project delivery and customer expectation management within Clinical Leadership/Project Leadership. I am responsible for direct reports that include managers globally and am also responsible for managing headcount within budget while delivering results for IQVIA customers. I have 25 years of functional operational management, planning and development experience obtained in academic, CRO, Pharmaceutical and niche provider settings. I thrive in new initiative and foundation-building opportunities. I am known for setting strategy, mobilizing teams and delivering on expectations.

Raleigh-Durham, North Carolina Area

Currently, provide senior oversight for management of resources, project delivery and customer expectation management. I am responsible for direct reports that include managers globally and am also responsible for managing headcount within budget while delivering results for IQVIA customers. I have 25 years of functional operational management, planning and development experience obtained in academic, CRO, Pharmaceutical and niche provider settings. I thrive in new initiative and foundation-building opportunities. I am known for setting strategy, mobilizing teams and delivering on expectations.

Cary, North Carolina

Key Responsibilities: Interacted with prospective and current clients as a member of the business development team.Served as a technical consultant for clients throughout all phases of a program.Consulted with proposal development staff to generate accurate business proposals.

Research Triangle Park, North Carolina, Usa

Key Responsibilities: Initiated and maintained peer level investigator relationships for current and potential studies.Performed comprehensive project management tasks and monitoring. Assisted with sales and marketing presentations and trade shows.Negotiated with sponsors for monitoring service contracts.Developed and managed a portfolio of clinical trial sites and sponsors.Ensured the comprehensive performance of study management for all.Monitored adherence to protocol guidelines and FDA and sponsor guidelines (GCP).Reviewed electronic case report forms for completeness and conformity to source.Conducted source document verification.Trained sites and monitors on the use of EDC systems.

Research Triangle Park, North Carolina, Usa

Key Responsibilities: On site technology representative for Glaxo Wellcome.Responsible for training site coordinators, Glaxo Wellcome and CRO monitors on use of electronic system.Provided consulting services.

Durham, North Carolina, Usa

Key Responsibilities: Managed all government and sponsor clinical trials.Supervised coordinators and support staff.Contracted with Pediatric Endocrine Division to manage divisional research projects.Performed as clinical site coordinator for greater than 46 ongoing studies both government grant, sponsor and investigator initiated trials.Responsible for data collectionIRB interactionAdherence to OHRP guidelinesManaged investigator pharmacyData submissionSerious Adverse event reportingPatient and staff clinical educationIn addition:National Cancer Institute/Pediatric Oncology Group AuditorResponsible for conducting site visitsAudited case report formsAudited investigational drug logs and conducting investigational drug inventoryAssessed protocol eligibility and responseEvaluated adherence to OPRR guidelines and GCPReported to Chairman of Cooperative Group