Rebecca Bichard Email & Phone Number

Flemington, NJ, US

New Jersey, United States

Provide oversight and leadership of Development Operations process development, compliance, and training to ensure continuous improvement and ongoing inspection readiness for the department. As primary point of contact for clinical process and training related activities, works closely with study teams to ensure processes are consistent, improvements.

Tarrytown, N.Y. And Basking Ridge, N.J

• Partner with Leaders and SMEs from assigned functional areas to identify process gaps, forecast needs and set priorities for development and implementation of on time, high-quality procedural documents (SOP, WI.
• Minimize compliance risks by presenting findings from Partnership Meetings during Procedural Document Governance Meetings to gain alignment/agreement on next steps and ensure that all requests are triaged appropriately
• Contribute to change management and Risk Mitigation Plans for company procedural document initiative by providing insight into feasibility of approach and deliver planned communications
• SME for redesign of procedural document development lifecycle as part of company procedural document initiative
• Design and implement a risk-based triage approach for procedural document requests; lead efforts to design, develop and test SharePoint based tracker that provides transparency and ability to manage projects/resources.
• Manage/oversee assigned high-priority/urgent projects to meet inspection commitments/CAPA; all projects met or exceeded timeline expectations

Tarrytown, N.Y. And Basking Ridge, N.J

• Design then lead effort to develop an electronic performance support system for Phase 1-3 clinical trials using SharePoint 2013; presented product during 2nd Annual Life Science Compliance Training conference
• Supported Regulatory Agency inspections by acting as SME on procedural documents, creating reports and compiling study-specific documents to address Inspectors’ questions
• Support implementation of new Learning Management System to ensure that new system supports business requirements for procedural documents
• Establish departmental standard for the assignment of procedural documents to training curricula thereby removing inconsistencies and streamlining the assignment process ensuring that all procedures are consistently.
• Create and deliver comprehensive global training/performance support solutions for regulated procedures (e.g., ICF Development/Approval, SAE Reconciliation, Investigator Alert Letters, Vendor Management, Inspection.
• Identify gaps and redundancies in existing procedural document portfolio by comparing existing SOPs/WIs against regulations (e.g., Code of Federal Regulations Title 21 and International Conference on Harmonisation-Good.

Tarrytown NY, Basking Ridge NJ

• Review and develop over 20 robust procedural documents based on audit findings, process improvement efforts and routine process reviews for regulated processes (e.g., Inspection Readiness, Electronic Data Capture and.
• Define/develop/implement performance support solutions for high-priority projects (e.g., Monitoring Oversight, Escalation of Suspected Serious Non-Compliance, Vendor Management)
• Identify process gaps and provide expertise on project and change management, performance and training solutions to enable future state of growth for the Compliance and Training group
• Improve process for releasing new procedural documents which reduced time to approval and eliminated redundant processes

Cambridge, MA

• Review existing SOPs to identify roles and define role-based training matrices for implementation of new LMS
• Create Introduction to GxP presentation used for on-boarding all new hires
• Author GxP Training Program SOP

Princeton, NJ

• Lead the global rollout of learning management system for over 10,000 employees with offices in 60 countries
• Manage up to seven learning professionals based in US, Europe and Asia/Pacific regions; mentor and coach two direct reports into senior manager level positions
• Establish and manage Service Level Agreement with Marketing Group after gaining consensus on training strategy and implementation plan; required 18 months for completion and was a first-time achievement for this.
• Introduce Info-Mapping methodology to revise onboarding and training materials subsequently decreasing new hires’ learning curve by two weeks
• Implement innovative training solution for Asia/Pacific region reducing the need for one FTE Trainer
• Develop and co-present at Electronic Data Capture at CRO Partnerships Conference held by the Institute of International Research, April 2010

Lawrenceville, N.J.

• Design and develop training and performance support tools (e.g., self-study modules and eLearning) for Electronic Data Capture system for clinical and data management roles;
• Reduce development time for eLearning and instructor-led learning solutions by one month by training staff on Instructional System Design methodology and tools (e.g., Captivate, Articulate and SnagIt)
• Manage global Peer Trainers Network, which enabled face-to-face technical training for employees in their native language thus decreasing the learning curve and training time while providing career development.
• Increase productivity for new hires by streamlining on-boarding content and enhancing performance support measures including quick reference cards, video tutorials, and skill-based manuals for clinical and data.
• Provide oversight for ten CRO trainers acting as primary point of contact between CRO trainers and project staff: develop technical training materials, conduct train-the-trainer sessions, hold quarterly calls, and.

Design, develop and deliver training solutions for data management technology and processes

Jersey City, NJ

• Direct oversight of 22 full time employees and up to 20 temporary employees: Data Entry Operators, Quality Assurance Managers, CRF Design Specialists
• Develop and maintain company quality standards for CRFs and Data Entry that reduced development time for paper CRFs from three hours per page to thirty minutes per page
• Design and implement CRF tracking report that reduced time to create project and program specific reports from four hours to thirty minutes

Maed, Education

I received my Masters of Education in Curriculum and Instruction with a specialization in Adult Education.

Bsn, Nursing