Principal Clinical Data Manager Resume Example
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VanessaWhitlow-Leverett
Summary
Experienced Clinical Data Manager and Manager offering 21 years of success in clinical trial management. Strategic thinker with program and project management proficiency. Proactive leader with strengths in communication, training and collaboration. Proficient in leveraging clinical trial knowledge to identify issues and develop solutions to insure successful programs. Strong relationship builder works well with stakeholders and corporate teams. Adept at managing concurrent objectives to promote efficiency and influence positive outcomes.
Skills
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Experience
Manager, Program Management Oncology, Company Name, July 2021-CurrentCity, State
- Oversight and execution of Data Management operations to a program of studies within a therapeutic area to ensure cross study collaboration and communications
- Manage, mentor, and train a team of Clinical Data Managers and Clinical Data Associates
- Provide line management, oversight, and resourcing for all data management operational activities in support of both clinical and non-clinical research studies from study build through study close
- Serve as a subject matter expert in a therapeutic area to build expertise across the team structure
- Effectively plan and execute multiple Data Management projects simultaneously in conjunction with support Data Managers, Data Associates, Clinical Programmers, Medical Coders, Biostatisticians and IRT Management. Provide updates directly to senior stakeholders.
- Responsible for capacity assessment, resource allocation and reporting to Senior CDM Leadership team
- Participate in Business Development presentations and bid development
- Assign tasks and responsibilities within data management team to optimize team members capacity, delivery of timely and accurate results in support of business needs
- Lead standards and process enhancement initiatives
- Manage sponsor relationships and triage issues
- Participate in Sponsor and Regulatory audits or inspections
- Maintain quality control of clinical data, project deliverables and closeouts
- Adhere to company quality system, including compliance with data integrity and business ethics requirements
Principal Clinical Data Manager, Company Name, June 2020-July 2021City, State
- Effectively plan and execute multiple Data Management projects simultaneously
- Provide updates directly to senior stakeholders
- Serve as a subject matter expert
- Participate in Business Development presentations and bid development
- Assign tasks and responsibilities within data management to team members to optimize team capacity, delivery of timely and accurate results, and to support the needs of the business
- Provide mentoring and coaching to data management staff in daily operational activities
- Communicate with cross functional groups and stakeholders throughout project lifecycle
- Manage sponsor relationships and triage issues
- Participate in Sponsor and Regulatory audits and inspections
- Maintain quality control of clinical data, project deliverables and closeouts
Principal Clinical Data Manager, Company Name, April 2016-April 2020City, State
- Responsible for developing data management-related presentation and participate in bid defenses with potential clients.
- Responsible for all aspects of clinical database development, maintenance and closure for multiple complex projects.
- Participate in study-related risk assessment and risk mitigation activities.
- Provide assistance throughout the life of the study to full study team, including internal, client and site users.
- Maintain timelines and budget for assigned projects.
- Create agendas and communication materials for study team meetings and training. Attend all study-related meetings.
Senior Clinical Data Manager, Company Name, March 2010-April 2016City, State
- Participate as data management representative at bid defense meetings with potential clients.
- Responsible for database development, maintenance and closure for multiple projects.
- Responsible for development of Data Management Plan specific to each project.
- Responsible for project-specific external vendor data transfer agreements, data transfer receipt and reconciliation to clinical database.
- Develop and provide CRF completion training to CRAs and Site personnel at Investigator Meetings, Kick-off meetings or as needed.
- Develop and provide on-going training to study team members to insure completion of data management-related tasks are performed correctly and consistently. This includes group and one-on-one training and Work Instruction Documents.
- Work closely with team members to improve operational processes to provide project deliverables per timelines and within budget.
- Provide data management metrics and study status updates for study team meeting agendas. Attend all study-related meetings.
Lead Clinical Data Manager, Company Name, January 2008-March 2010City, State
- Responsible for clinical database development, maintenance and closure for one to three projects.
- Database development activities including Protocol review, CRF development, database design, IxRS integration, Edit Check specification, ePRO/eCOA integration, Targeted SDV specification development and implementation, medical coding and CRF Completion Guidelines.
- Database maintenance activities including database modification and migration, data review, cleaning and freezing, regular study metrics reporting and external data reconciliation. Work with the client to facilitate on-going data review.
- Database closure activities including SAE Reconciliation, Coding review, data review meetings and activities, database lock and closure.
- Provide exceptional service and attention to customers when face-to-face or through phone conversations. Increased customer satisfaction by finding creative solutions to challenges and problems during the course of the study.
- Attend study-related meetings
Research Scientist, Company Name, August 2000-June 2007City, State
- Research of plasmid-based DNA vaccines, particularly involved in the program to develop an Anthrax vaccine.
- Laboratory experience including cloning, bacterial fermentation, DNA isolation, cell culture, microbiology, and Southern and Western blots.
- Immunological assay development and assay validation (ELISA).
- CGCP documentation and processes, including writing SOPs for all processes.
- Clinical sample receipt and tracking following laboratory guidelines for biological specimens. Maintained confidentiality of patient information.
- Maintained secure study immunological data collection, analysis, and reporting.
- Authored testing reports and delivered knowledgeable input on publication literature.
- Shared research findings through publications, presentations and conferences.
- Recorded and reported test results, performing calculations, producing graphical solutions and representations.
Education and Training
Bachelor of ScienceMolecular And Cell Biology, , California State University - San Marcos, CityState
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Resume Overview
School Attended
- California State University - San Marcos
Job Titles Held:
- Manager, Program Management Oncology
- Principal Clinical Data Manager
- Senior Clinical Data Manager
- Lead Clinical Data Manager
- Research Scientist
Degrees
- Bachelor of Science
