Data Management Quality Assurance

Kimberly Johnson Longo

** ********* *****

Clayton, NC 27527

919-***-**** (M)

**********@*****.***

OBJECTIVE

Experienced Data Management Professional with over 20 years of expertise in designing, implementing, and optimizing data management systems. Proven track record in data governance, data quality assurance, and analytics, with a strong ability to transform complex data into strategic insights that drive business growth. Seeking to leverage extensive knowledge and leadership skills in a dynamic organization committed to data-driven decision-making.

SUMMARY OF QUALIFICATIONS

● Managed global teams ranging from clinical data associates, lead project data managers to principal level clinical data programmers.

● Responsible for study team escalations, resourcing, performance reviews, work assignments, and daily tasks.

● Confident in financial areas, including reviewing proposal budgets and reviewing DM aspects of ongoing studies.

● Establish great relationships with customers and able to conduct successful meetings. As project data manager, worked on a 9-year long sponsor program/portfolio, as well as multiple smaller-scale programs.

● Familiarity with data integrations with various systems/platform, including ePRO and eCOA.

● Experience in Master Data Management (MDM) initiatives related to data management items (built lifecycles for various domains and working with IT/functional areas enforcing rules to export data into a data lake environment).

● Involved with and very familiar with innovative data capture systems using latest industry technology.

● Developed DMP for ePlatform studies and vendor agnostic toolkits to use for various ePlatform studies.

● Familiarity with running listings in SAS and using basic SQL language/logic.

● Flexible, dedicated, out-going personality, and excellent team player.

● Years of experience as a project data manager leading large, global studies for reputable sponsors.

● Experience with on boarding new employees for i3 statprobe.

● Received several “recognition” awards within i3 statprobe and INC Research/Syneos.

● Considered a “go to” person for certain internal processes and systems.

● Trained in developing trials and writing rules using InForm Architect.

● Involved with and very familiar with the clinical process.

● Have CRF designing experience across various therapeutic areas within GSK and i3statprobe.

● Years of experience with pragmatic use of CRF standards. EDUCATION

M.S. Clinical Research Administration, George Washington University Washington, D.C. December 20, 2008

B.S. Animal Science/Pre-Veterinarian curriculum, North Carolina State University Raleigh, N.C. May 1999

Dean’s List

RELEVANT EXPERIENCE

JUN 2023-Present Otsuka, Associate Director, Data Management The Associate Director of Data Management supports the Director in providing leadership, direction, and operational management for the data management team. This is a leadership position responsible for developing and accountability for the Protocol Data Managers in their assigned program; and for meeting assigned operational targets including but not limited to quality, performance, utilization, retention and training.

● At a program level, act as Data Management expert to develop data management strategies, identify, and implement methodologies and technologies to best support projects.

● Drive continual improvement across a program and effectively share lessons learned and best practices across projects/programs.

● Represent Clinical Data Management on the program governance teams / joint operations committees.

● Manage the scope, budget, and resources for assigned projects/programs.

● Develop and maintain SOPs and working practice documents for data management tasks in collaboration with representatives from other functions and therapeutic areas.

● Proactively identify risks and executes risk mitigation strategies.

● Maintains timely communication with management and cross-functional teams.

● Establish and manage data capture, management, and review standards to ensure the quality and integrity of clinical research data in compliance with global regulatory requirements.

● Provide consultation, leadership, and expertise to clinical development functions in the areas of data handling and data management processes.

● Evaluate Electronic Data Capture (EDC) and other data collection technologies for implementation.

● Participate in the development and maintenance of standard eCRFs and associated edit specifications.

● Represent data management on key company initiatives.

● Participate in new hire process, onboarding activities, mentoring, and training of DM staff.

JAN 2023-JUN 2023 Propharma Group, Associate Director, Data Management ProPharma Group focused on providing program management and execution-based consulting within the life science industry. The Associate Director Data Management reported to the Director, Data Management, and provided database development services to ProPharma Group clients.

● Coordinated and managed the work of the assigned Data Management team.

● Assisted in resource planning, staff training, and direct reports’ performance reviews.

● Developed strategies and supported Data Management team to drive programs according to agreed timelines; if changes were proposed to agreed milestones and timelines, assisted Data Management personnel in evaluating the risk of these decisions and developed plans to minimize/mitigate these risks.

● Accountable for customer satisfaction and identified Key Performance Indicators related to Data Management deliverables.

● Attended and presented capability and bid-defense presentations with clients to support the development of new business.

● Attended RFI/RFP proposal strategy meetings and operationally lead strategy development and approved client proposals and budgets.

● Worked closely with Quality Assurance to ensure quality and continuous process improvement throughout the clinical and medical operations departments.

● Functioned as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables.

● Functioned as Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups.

● Ensured launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.

● Provided project specific training to internal and external audiences as required.

● Responsible for financial management of assigned projects / programs, including revenue recognition and changes in scope.

OCT 2021-JAN 2023 Syneos Health, Associate Director, Clinical Programming The position was responsible for hiring, managing, developing and being accountable for the Clinical programming staff including management in the assigned team and the department; and for meeting assigned operational targets including but not limited to quality, performance, utilization, retention and SOP training.

● Managed clinical programming operations by providing direct line management of departmental senior managers and managers. Line management responsibilities including professional development, performance appraisals, and employee counseling for junior and management staff.

● Assigned project work and reviewed workload for all direct reports. Managed staff by establishing goals that increased knowledge and skill levels, and delegated tasks commensurate with skill level. Managed group resource needs and made recommendations to management. Worked with and advised subordinates on administrative policies and procedures, technical problems, priorities, and methods.

● Developed training materials associated with Clinical Programming operations and delivered training to Clinical Programming department and others with needs for Clinical Programming information.

● Created and reviewed proposals and change orders.

● Attended bid defenses, study kick off, project review, and departmental review meetings.

● Ensured high quality deliverables at regional level by providing senior review of core deliveries for accuracy, performing in-progress audits, and attended sponsor audits.

● Ensured project timelines and scope of work were achieved as on-time, high quality deliveries.

● Prepared activity, resource, and progress reports regarding the clinical information systems group for upper management review.

● Provided oversight or participated in the development of project specific software applications and ensured company documentation and computer system validation requirements were adhered to.

● Utilized primary development tools including Oracle RDC, Medidata Rave, SAS, custom reporting, and other supporting tools.

● Monitored applications proactively for workflow alerts, system errors, performance issues.

● Lead/Assisted in the creation and documentation of new or revised departmental procedures.

AUG 2019-SEPT 2021 PRA Health Science, Senior Manager, Data Management Line Management and functional support of Project Data Managers and Clinical Data Coordinators. Responsible for recruitment, growth, and development of employees. Provided leadership, direction and high-level expertise in the implementation of quality initiatives and business processes. Achieved goals and objectives within the framework of the company mission, policy and philosophy. Managed resources and resource projections to ensure project teams were consistent with client needs, expectations, and contractual obligations.

● Coordinated activities and personnel and properly allocates resources.

● Assigned staff resources for client project teams and worked to ensure clinical data management activities were executed in a high-quality, timely manner.

● Mentored clinical data management staff across multiple project teams. Ensured that staff fulfilled their responsibilities in accordance with company policies, Standard Operating Procedures (SOP), International Council on Harmonization

(ICH) and Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements.

● Achieved staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and instructing employees; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.

● Recommended and implemented clinical data management performance and productivity improvements to ensure optimal use of billable staff.

● Participated in business development initiatives, including presentations and proposal development.

● Performed metric collection and data analysis to improve policies, procedures, and business processes.

● Represented the department on company, division, or department-level process improvement initiatives.

● Provided expertise on clinical data management, and escalation support, for issue resolution and contingency planning.

● Participated in internal/external audits and regulatory agency inspections as required.

● Responsible for recruitment activities such as reviewing CVs, candidate interviews, candidate selection process and onboarded new hires.

● Lead internal department initiatives that were less complex in their scope of services, technology employed, volume and/or revenue. OCT 2014-AUG 2019 Syneos Health (formerly known as INC Research), Manager, Data Management

Provided line management and functional support of Project Data Managers. Also included staff mentoring and development, resource management, project finance, operational project support and sponsor communication.

● Performed deep dives into budgets related to data operations to determine areas of improvement, more efficient strategy during study conduct, and/or change order implementation. Able to navigate through the budget effectively.

● Line management responsibilities included professional development, performance appraisals, and employee counseling for Project Data Management staff. Monitored and reviewed workload for all direct reports.

● Managed staff by establishing goals that increased knowledge and skill levels, and by delegating tasks commensurate with skill level.

● Provided staff performance development and utilized mentoring and coaching techniques, performed regular performance reviews, and implemented disciplinary actions if necessary.

● Managed the resource/workload of the team, assigned tasks to team members, and subsequently monitored productivity / utilization, timeliness, and quality.

● Ensured team awareness of evolving working practices/policies/work instructions.

● Held regular data management team meetings to communicate study/departmental information.

● Identified best practices and investigated root causes across fundamental issues and problems for projects, and recommended solutions.

● Represented Data Management in project related cross-functional study team meetings.

● Performed cross-functional communications where issues were judged to need clarification and /or resolution.

MAR 2010-OCT 2014 INC Research, Senior Project Data Management Acted as Project Leader on a stand-alone contract ("project") for Data Management, to include primary customer contact for all contracted Data Management and direct liaison with Finance and Contract department on required matters (e.g. invoicing, contract changes).

● Promoted to Senior Project Data Manager in June 2012.

● Acted as Functional Team Lead for Data Management on full-service contracts that included primary contact for internal liaison between Data Management and INC Project Management, Clinical Monitoring, and other functional groups on 'full service' contracts and liaised with Finance and Contracts groups via the Project Leader (e.g. concerning invoicing, contract changes).

● Managed changes of scope, budget, revenue recognition, and participated in monthly internal project reviews.

● Monitored and communicated project progress to the customer and project team including use of project status reports and tracking tools/metrics.

● Developed and maintained Data Management Plans, Project Management Plans (for standalone contracts only), Communication Plans (for standalone contracts only), SAE Reconciliation Guidelines, Quality Plans, and other plans as delegated/required.

● Assisted in the negotiation and contracting process with outside vendors such as e-CRF/Diary vendors, CRF Printer and IVRS vendors.

● Regularly reviewed project files to ensure that all filing was up to date.

● Managed the database freeze and lock processes and procedures.

● Ensured that all applicable documents and databases (data sets) were archived or returned to the customer appropriately.

● Co-ordinated user testing per User Test Plans developed for data entry screens, electronic edit checks, data listings, import / export programs and medical coding.

● Provided project specific training.

● Managed Quality Control (QC) process for checks of CRF database versus Case Report Forms (CRFs) and Data Clarification Forms (DCFs):

● Scheduled and requested data transfers/imports/exports to/from CRF/eCRF database, and associated databases.

● Reviewed and approved project plans and guidelines for data validation, electronic data interchange, coding, CRF/eCRF screen, database design, user testing, CRF tracking, CRF / eCRF completion and other applicable project plans as delegated/required; specifications for listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources; and output from listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources.

● Participated in, and presented at internal, customer, third-party and investigator meetings.

● Planed for and created necessary documentation to support internal and external audits and participates in such audits.

JUL 2008 – FEB 2010 i3 Statprobe, Clinical Data Manager II Delivered high quality clinical data for a major Pharma company within a timely and cost productive manner.

● Responsible for leading study within endocrine therapeutic area.

● Handled discrepancy management using eDC platform (e.g., InForm).

● Authored and updated Data Management Plans and other key study documents.

● Supported training of project staff (CDC’s, CRA’s, etc.) on project specific or data management processes.

● Directed activities associated with data integration and data.

● Regularly liaised with monitoring, database programming, medical coding, and statistical programming teams to ensure smooth functioning of a study.

● Liaised with clients and produced trial progress reports.

● Managed third party vendors to ensure quality of data.

● Responsible for reviewing test transfer data and discussed issues with data movement/stats.

● Responsible for data lock process.

JUN 2006- JUL 2008 i3 Statprobe, Senior Data Collection Coordinator Delivered quality CRFs (including paper and electronic) for a major Pharma company in a timely manner. Created quality data entry screens based on CRF.

● Considered a “go to” person for technical questions related to eDC platform.

● Developed eCRFs using InForm Architect. Develop CRFs for major Pharma Company using Indesign and PageMaker for paper design purposes.

● Experienced in xml code changes for use with InForm studies. Developed CRFs using xml code.

● Developed and maintained therapy CRF standards.

● Created data entry screens in Clintrial, as well as specific study set up tasks involving attaching customized codelist to panels and programming certain item properties.

● Pioneered the process of CRF Design involving an alliance between a CRO and a major Pharma company.

● Assisted new employees on how to access programs related to remote access related to the alliance.

● Experience with using Citrix Client to access all programs needed to do CRF Design work for an alliance.

● Ability to read and interpret assessments needed per study protocol.

● Performed resolutions to change request involving corrections to CRF and CRF standard pages.

2005-2006 Rho, Inc., Clinical Data Associate

Delivered high quality data to sponsors in a timely manner.

● Acted as internal project lead for study involving a major Pharma company.

● Escalated any study issues within study team and to the appropriate sponsor contact.

● Set up several studies for preparation of entering data into the Rho data management system.

● Proposed and created structure for CRF Standard Library using standards pages designed in FrameMaker.

● Performed the standard procedures required to process the research data produced in the clinical development stages of a drug, biologic product, or medical device.

● Developed clean data for sponsors in a timely manner which included: reviewing of protocols and applying protocol-specified guidelines to the review and cleaning of clinical data, entered data from paper forms into the project-specific data entry system, set up project files, maintained patient folders, proofread data listings and other data displays, and interpreted computer output.

● Assisted with writing and resolving queries.

● Assisted with the creation, training and implementation of data management plans, data entry guidelines, data completion guidelines and other study documents.

2002-2005 GlaxoSmithKline, CRF Designer

Designed quality CFRs for clinical trials per therapeutic area in a timely manner.

● Trained in study set up and writing rules using InForm through Phase Forward.

● Able to determine how to integrate standard CRF pages into a study set in InForm.

● Familiarity with determining what types of forms to use for CRF pages using InForm tools.

● Familiarity with various clinical processes such as RAMOS, electronic diaries, electronic CRFs.

● Facilitated meetings with customers from certain therapeutic areas to review CRFs.

● Involved with writing standard guidelines for CRF processes.

● Able to interpret what is needed in the draft of the CRF per a draft protocol.

● Developed therapeutic area standard pages for the Migraine and Anti-Viral therapeutic areas.

● Main CRF Design contact person for the HIV and Valtrex therapeutic areas. 1999 - 2002 GlaxoSmithKline, Associate Scientist

Provided analytical support for the development and validation of various inhalation products.

● Assisted in development of clearer understanding of technical principles that govern particle size distribution testing of Ventolin HFA and assessed product’s in-use stability in response to FDA’s approval letter.

● Validated the particle size method for ADVAIR HFA and evaluated the product’s fine particle mass performance throughout the duration of the manufacturing quarantine period.

● Provided analytical support for the development and proof of concept study for the hydrolyzable steroid project.

● Gained vast technical knowledge of GSK’s renowned inhaled products. 1996-1998 Fisher Veterinary Hospital, Veterinary Assistant Demonstrated flexibility in and responsibility for laboratory and kennel management tasks.

● Involved with the promotion of certain preventive products for animals.

● Performed microscopic fecal test for whipworms, roundworms, tapeworms, and heartworms.

REFERENCES: Available upon request

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