Shari Clark Email and Phone Number

Manages customer-facing projects, including requirements gathering, SOW creation, execution and stakeholder management.Provides customer-facing product training and implementation and internal product training.Documents product functionality.Supports customer lifecycle through executing existing programs and/or contributing to the development of new programs.Serves as SME and point of escalation for Support case troubleshooting.

Manages resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual obligationsReviews project tasks and timelines and assigns team members. Leads clinical data management project teams in the delivery of services to clients.Ensures staff fulfills their responsibilities in accordance with PRA's policies, procedures, SOPs, ICH-GCPs, and other relevant regulatory requirements.Liaises with other functional managers to ensure consistency of clinical data management approach within the company.Recommends and implements clinical data management performance and productivity improvements to ensure optimal utilization of billable staff.Performs metric collection and data analysis to support PRA's efforts for continuous improvement in policies, procedures, and business processes.Identifies and implements process improvements through review of clinical data management SOPs, processes; recommend improvement plans to senior management.Leads task forces to implement process improvement initiatives.Builds teamwork and improves process and productivity by working within and across functional areas.Participates in business development initiatives, including presentations and proposal development.Ensures that timely and accurate information is submitted on all proposal efforts.Develops PRA employees to ensure high quality work performance and retention of high quality employees.Ensures staff development and performance feedback are provided through activities such as mentorship and career development.Communicates team/individual goals and expectations to ensure direct reports understand their responsibilities

Advanced knowledge of data management processes and systemsWork across functions (Project Management, Clinical Site Monitors, Clinical Data Programming, and Clinical Data Services) within Quintiles to complete data management projects.Work directly with client and sites to complete projects within set timelines.Ensure data management project is completed within budget and Scope of Work.Provide complete accurate documentation for a project study file following ICH/GCP Guidelines and Quintiles operating procedures and work instructionsPerform QC audits on critical data as well as data specified in the QC PlanOrganize receipt of external data (data provided by external vendors) not included on CRF. Work with programmers to load external data into clinical data management computer system.Participate in project team teleconferences, including internal team members as well as external vendors and client representatives.Provide project status reports and metrics.

Manage and direct the work of a group of Data Coordinators and Data Coding Specialists. Responsible for career development, performance reviews, training, resource allocation across multiple projects, and recruiting. Responsible for RFP budget and proposal review and managing budget once contract awarded. Ensure understanding and compliance with SOPs, and data management practices for Phase I, II, III, IIIB and Late Phase studies.Responsible for timelines and the quality of the output of Data Coordination. Develop Late Phase data management process standards used across North America sites with the strategy to implement globally as business grows.

Initiate, design, create, and provide documentation of Oracle databases for clinical drug projects following Quintiles SOPs.Define, implement and test data quality checks in PL/SQL according to specifications.Liaise with vendor contacts providing external data.Recognize customer needs and provide the services to meet their needs.Associate Manager of EducationDefined training strategies based upon investigation of current processes and software application implementation and/or upgrades for Clinical Data Programming at each Quintiles North America site.Negotiated with outside vendors to provide cost effective technical training to clinical data programmers for each Quintiles North America site.Led communications with global counterparts to develop and share training materials for global use.Actively analyzed new electronic training technologies and researched the vendors offering the training technology products and services.

Directed the organization and implementation of projects initiated in the Information Systems department.Directed the clinical trials computer system development and implementation project.Authored the System Development Project documentation.Defined specifications for programmers in designing, creating and implementing the clinical trials computer system.Defined training strategies and implemented the strategies for the clinical trials computer system.System Administrator to laboratory information system and anatomic pathology computer system.System AdministratorLed the implementation of the anatomic pathology computer system.Defined training strategies and implemented the strategies for the anatomic pathology computer system.Instrumental in bringing electronic signature to the Anatomic Pathology and Cytology departments.Assisted LIS System Administrator in the maintenance of the LIS.Supervisor, Patient Care Services, Specimen Processing and PhlebotomyLed the project of producing a vital Patient Care Services department including authoring procedure manuals and job descriptions, interviewing and hiring personnel, and managing personnel.Managed staff and provided direction for employees of three departments; Patient Care Services, Specimen Processing and Phlebotomy; covering day, evening and night shifts at two sites (35 employees) .Performed performance appraisals and maintained personnel files for each employee (company did not have al Human Resource department).Provided operational input to the laboratory information system (LIS) vendor in designing the Client Services module for the LIS.

Worked in each department (Toxicology, Chemistry, Special Chemistry, Hematology, Infectious Disease, and Specimen Processing) in the laboratory as a "float" to assist where ever necessary, often multiple departments within a shift.Worked all shifts in the float position.

Managed the organization, operations, and personnel of the Clinical Trials division, abiding by GLP and GCP guidelines.Mentored staff members to develop expertise in providing central laboratory services.Provided strategic technical advice to the IS department programmers to direct the design and implementation of future enhancements to the clinical trials computer system.Partnered with the Director of Clinical Trials in the evaluation of protocols to determine necessary central laboratory services in preparation of proposals.Developed relationships with Sponsors, CROs, and sites to provide exceptional central laboratory services.