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director of data management resume example with 11+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
Summary

Results-focused Director in Global Clinical Data Management with reputable professional experience and extensive strength in Clinical Data Management, Customer Relations, and Innovative thinking. Proactive leader with strengths in communication and collaboration. Proficient in leveraging over 13 years of Clinical Data Management experience and database knowledge to promote efficient and complete Data Management deliverables with the highest of quality. Adept at managing concurrent objectives to promote efficiency and influence positive outcomes.

Skills
  • Staff training, enablement and management
  • Strategic marketing, leadership and design
  • Data analytics and reporting
  • Complex project negotiations
  • Compelling leadership skills
  • Key account development and revenue cycle forecasting
  • Continuous process improvement
  • Advanced skills in multiple EDC systems, expert in database design
Certifications
  • Licensed Registered Nurse in NY - 2015
  • Merative Clinical Development Designer.
  • Merative Clinical Development Designer Smart Reports with Cognos
Experience
Director of Data Management, 12/2021 - Current
Lewis Pr San Francisco, CA,
  • Responsible for managing day to day portfolio delivery and implementation of new technologies and study designs.
  • Managed daily operations by overseeing financials, key performance indicators and employee performance.
  • Updated procedures for Innovative Study Design to increase productivity and maximize resources and delivery.
  • Interviewed and hired talented performers, bringing exemplary expertise and knowledge to job positions within organization.
  • Fostered relationships with customers and vendors to expand customer base and enhance loyalty and retention.
  • Provided excellent service and attention to customers when face-to-face or through phone conversations.
  • Worked closely with other stakeholders to immediately address issues and implement effective solutions.
  • Partnered with subject matter experts in continuous improvement process, upgraded data quality and recommended innovative information management strategies.
  • Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problem.
Lead Merative (formerly IBM) Designer, 06/2020 - Current
Covance Lawrenceville, NJ,
  • Developed database architectural strategies at modeling, design and implementation stages to address clinical trial requirements.
  • Designed, configured, tested and maintained innovative risk based clinical trial systems, vendor programs and system management tools.
  • Reviewed project requests describing database user needs to estimate time and cost required to accomplish projects.
  • Knowledge in programming automated SAE processes and targeted SDV levels.
Senior Clinical Data Manager, 06/2020 - 12/2021
Bionical Emas City, STATE,
  • Project Manager/Project Lead for series/group of studies
  • Ensure project milestones are met according to agreed timelines.
  • Actively manage quality throughout project.
  • Actively participate on Initiatives, Process improvement, Customer focus areas.
  • Actively contribute to recruitment of new staff.
  • Define and prioritize resource requirements and manage resource assignments within the portfolio.
  • Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers.
  • Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency.
  • Participate in development and implementation of new processes and technology.
Senior Project Data Manager, 10/2019 - 06/2020
Syneos Health City, STATE,
  • Developed data management plans and reports, validation procedures and data entry processes as Project Lead to multiple studies.
  • Managed user access, including activating and deactivating accounts, upholding strict security standards in all areas.
  • Supported upgrades and migration of databases by completing user acceptance tests.
  • Developed technical specifications for data management programming to communicate information to technical staff.
  • Improved operations by working with team members and customers to find workable solutions.
  • Demonstrated leadership by making improvements to work processes and helping to train others.
  • Recognized by management for providing exceptional customer service.
  • Active Participant on customer initiatives and process development: Centralized Monitoring, EDC Process Improvement, and DES Standardization.
  • Act as escalation point of contact for internal and external customers for program / multiple projects.
Assistant Director of Data Management, 01/2019 - 10/2019
OPKO Health City, STATE,
  • Trained and mentored new employees on industry practices and business operations.
  • Act as main overall point of contact for internal and external customers for multiple projects.
  • Manage delivery of multiple projects through full data management study lifecycle.
  • Lead DM customer negotiations on complex timeline and other issues.
  • Manage comprehensive data management tasks pertaining to the Data Management Plan.
  • Manage comprehensive quality control procedures.
  • Provide data management expertise and data coordination process improvement to CDM management.
  • Provide Data Management with technical expertise.
  • Vendor Data set-up and management
  • Meet objectives as assigned.
Associate Data Team Lead, 08/2016 - 10/2019
IQVIA City, STATE,
  • Provide experienced comprehensive skills as part of a Clinical Data Management team to provide efficient, quality data management products.
  • Provide leadership to the team in the area of Data Management Plan Development and/or as the Lead Data Manager
  • Global Data Management lead on multiple trials.
  • Conducted training and mentored team members to promote productivity, accuracy, and commitment to friendly service.
  • Responsible for the management of study data for three separate studies including Study Start-up, Maintenance and Database Release.
  • Responsible for the preparation and set-up of Lab and IVRS transfer specifications for outside vendors.
  • Active participant in weekly study team meetings and team discussions in regards to data cleaning.
  • Extensive interaction with various Data Management and Medical Research colleagues, including: Coders, Database and Statistical Programmers, Statisticians, Clinical Research Scientists, Clinical Trials Managers, and Clinical Research Associates.
Associate Data Team Lead, 08/2015 - 08/2016
ICON Clinical Research City, STATE,
  • Served as a team leader to orchestrate data management tasks.
  • Implemented new technology and developing good communication and working relationships with both internal and external colleagues.
  • Responsible for the management of study data for a sponsor led study.
  • Provide feedback to client on various processes/documentation, including feedback on data checks to be used in data cleaning.
  • Established open and professional relationships with team members to achieve quick resolutions for various issues.
  • Responsible for budgets and monthly forecasting.
Head of Data Quality Control, 08/2010 - 08/2014
International Breast Cancer Study Group City, STATE,
  • Established the data quality control office working with 400 Sites in 30 different countries to increase data compliance from roughly 40% to 96%.
  • Project Manager/Project Lead for a series/group of studies
  • Ensure project milestones are met according to agreed timelines.
  • Actively manage quality throughout project.
  • Led and managed an electronic data capture study from Study Start-up, Conduct to Study Closure.
  • Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers
  • Developed and trained an electronic data capture Study Set-up, Conduct and Closure Guidance Document and created a process flow chart for new users of the system.
Affiliations
  • Decentralized Trials & Research Alliance (DTRA) - Leadership
  • Association for Clinical Data Management (ACDM)
  • Society for Clinical Data Management (SCDM)
  • Clinical Data Interchange Standards Consortium (CDISC)
Education and Training
MBA: Risk Assessment, Drug Innovation And Technology, Expected in 12/2025
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Johns Hopkins - Remote,
GPA:
Status -
Bachelor of Science: Nursing, Expected in 08/2015
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University At Buffalo - Buffalo, NY,
GPA:
Status -
Bachelor of Science: Biochemistry And Molecular Biology (Epigenetics), Expected in 05/2010
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Canisius College - Buffalo, NY
GPA:
Status -
Additional Skills
  • Cluepoints
  • Clinical Ink
  • DataFax
  • DataTrak
  • ePROs
  • IRT/IWRS Set-up
  • Inform
  • Medidata Rave, Rave Safety Gateway
  • Veeva EDC and Vault

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Resume Overview

School Attended

  • Johns Hopkins
  • University At Buffalo
  • Canisius College

Job Titles Held:

  • Director of Data Management
  • Lead Merative (formerly IBM) Designer
  • Senior Clinical Data Manager
  • Senior Project Data Manager
  • Assistant Director of Data Management
  • Associate Data Team Lead
  • Associate Data Team Lead
  • Head of Data Quality Control

Degrees

  • MBA
  • Bachelor of Science
  • Bachelor of Science

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