Hands-on Consulting focused on Sponsors and CROs who need intensive GCP support, education and project management.
•Direct coaching for leaders, staffand consultants on tactical and strategic clinical quality assurance during Phase I-III trials.
•Provide communication coaching to improve Sponsor and Health Authority interactions.
•Lead external and internal audits, annual audit planning and mock inspections.
•Lead technical writing (e.g., SOPs) and process mapping activities.
•Deliver data-specific quality assurance projects, as needed.
•Participate in Sponsor and Vendor meetings representing Clinical Quality Assurance.

Designed and taught course including quizzes, discussion and exams. Proposed courses accepted in new program. Courses were weekly live online lectures OR face-to-face (as allowed). Coordinated with students to support resume reviews.

Responsible for all QMS design, coaching and installation. Lead Audit and Inspection activities serving as Liaison between Sponsors and Health Authorities as needed.
•Lead SOP writing and approval processing need to support Audit Responses
•Lead all sponsor audit response activities.
•Process Mapping
•Design training management systems.
•Serve as Sponsor QA and Operations point of contact.
•Lead validation assessments and reporting for remediation.
•Lead meeting to review key concepts and GCP significance.
•Conduct QA reviews of pre and post data transfer outcomes. Achievements: Despite delayed start, created suite of process documents including processes maps.

Responsible for all QA & GCP activities at the organizational level while guiding staff on opportunities within exercise lab operations. Provide intensive hands-on QA and GCP guidance including bi-monthly training sessions, discussions and issue tracking to resolution. Served as organizations Program Manager for internal QMS-related projects.
•Establishing a basic quality management system within the lab without robust technologies.
•Worked 1: 1 with all staff to ensure QA & GCP understanding within a QMS
•Hosted all sponsor visits and audits
•Provided inspection coaching
•Conducted study-level QA activities.
•Led technical writing activities including Standard Operating Procedures
•Operations & Regulatory auditing and
•Stand-by as Health Authority Inspection QA contact. Achievements: Led organization through successful inspection readiness sponsor audit pre-data lock and assigned to other vendor needing same intense QA & GCP support. All completed multiple process maps for org

This role served as a point of contact across headquarter sites and affiliate teams for customers in the global clinical operations group across Roche. Program Manager for international communication and quality management system projects to drive a quality mindset across division.
•Partner with Safety, Regulatory, and additional stakeholders to drive compliance in process across departments.
•Support Inspection Readiness and direct support during health authority inspections.
•Lead cross-functional quality programs and projects including Quality Culture.
•Support team on their project design. Coach Quality Managers in project management
•Provide strategic consult to leadership team for resourcing, communications.
•Navigate and escalate stakeholder management concerns.

Point of contact across headquarter sites and affiliate teams for customers in the global clinical operations group across Roche.
•Support global compliance activities for clinical operations teams across multiple therapeutic areas, modalities and vendors. Direct CAPA management. Used RAVE to explore data as needed.
•Finalized establishment of helpdesk operations including routing/escalations, stakeholders and customer contact expectations.
•Lead site inspection for regulatory authorities and internal auditors
•Develop and establish metrics for quality and success.
•Worked across therapeutic areas including Oncology, Immunology, Neurology.

Responsible for ensuring local and aligned global compliance of laboratory processes within GLP and GCP requirements. Site Lead for global internal and external inspections & audits.
•Designed and executed audit prep program for large multi-location team.
•Improved relationship between compliance team and laboratory staff to support transparency and CAPA.
•Managed LIMS risks through data monitoring and 1: 1 audit with users.

Field monitor for large Clinical Research technical service providers including imaging, laboratory, and IxRS services. Additional training in ePRO, ECG, esoteric lab testing.
•Planned visits based on study and vendor risks. Completed onsite reports.
•Coached CRO teams on management of sponsor expectations.
•Improved mutual oversight directly impacting patient safety and data quality.
•Met directly with Executive Quality management on behalf of sponsor support 'Quality to Quality' meetings.

Line Manager (maxed out at 30 direct reports). Research Associates and Assistants reported to me. Managed imaging operations for 75+ global clinical studies. Lead staff meetings, onboarding to EDC systems and standards as a CRO.
•Presented at Genentech and Biogen Idec meeting as Imaging Vendor. 400+ attendees.
•Briefly reported directly to the EVP of Global Clinical Operations
•As dept. lead, provided framework for imaging data management system.
•Managed staff issues if reported by Sponsor

Lead 4 imaging Rheumatoid Arthritis studies as lead for X-ray & MRI collection
•Support all data cleaning from start to lock. Eventually approved for commercialization.