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Principal Clinical Data Manager Resume Example

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PRINCIPAL CLINICAL DATA MANAGER
Summary

Experienced Clinical Data Manager and team leader offering 15 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
  • Meeting project-driven timelines
  • Phase I - III domestic and global trial experience
Experience
Principal Clinical Data Manager, Synteract, Inc., April 2016-April 2020Carlsbad, CA
  • 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, Synteract, Inc., March 2010-April 2016Carlsbad, CA
  • 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, Synteract, Inc., January 2008-March 2010Carlsbad, 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, Vical, Inc., August 2000-June 2007San Diego, CA
  • 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, San MarcosCA
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Resume Overview

Companies Worked For:

  • Synteract, Inc.
  • Vical, Inc.

School Attended

  • California State University - San Marcos

Job Titles Held:

  • Principal Clinical Data Manager
  • Senior Clinical Data Manager
  • Lead Clinical Data Manager
  • Research Scientist

Degrees

  • Bachelor of Science

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