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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
Medidata Rave Certified Study Builder and Administrator
Critical thinking and decision making
Open and proactive communication
Creative solutions to problems
Team building and mentoring
Phase I - III domestic and global trial experience
Regulatory knowledge and oversight
Project and timeline management
Staff recruiting and development
Process and Documentation development
Experience
Manager, Program Management Oncology, 07/2021 to Current Tfs – California City, CA,
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, 06/2020 to 07/2021 Tfs – Cary, NC,
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, 04/2016 to 04/2020 Covance – West Trenton, NJ,
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, 03/2010 to 04/2016 Johnson & Johnson – Kansas, IL,
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, 01/2008 to 03/2010 Intel Corp. – Folsom, CA,
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, 08/2000 to 06/2007 Vical, Inc. – City, 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 Science: Molecular And Cell Biology, Expected in California State University - San Marcos - San Marcos, CA GPA:
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