Principal Clinical Data Specialist
Current- As Principal Clinical Data Specialist (CDS), lead and oversee all data management activities and responsibilities for multiple clinical trials across multiple therapies;- Lead and support various departmental, business unit, and corporate level, process and system changes and improvements;- Support transition to Clinical Data Interchange Standards Consortium / Clinical Data Acquisition Standards Harmonization (CDISC/CDASH) standards by participating as departmental and functional lead for data management best practices, including input to therapy level needs. Also act as data management functional lead for standards committee center of excellence for ongoing maintenance and modifications to initially defined standards specifications;- Extensive audit experience, including provided data management support for FDA audit with a heavy focus on data management, resulting in zero findings or actions needed. - As result of audit participation identified a need for guidance for individuals without audit/inspection experience, and so created an 'Audit Preparation User Guide' for department; - Knowledgeable in multiple reporting platforms;- Experienced user of Clinical Trials Management System (CTMS);- Successful mentor and trainer to new CDS;- Disciplined user of Good Clinical Practice (GCP), Good Documentation Practice (GDP) and 21 CFR Part 11;- Proven project management abilities and demonstrated communication skills;- Constantly gaining new skill sets by seeking out learning and advancement opportunities.
