Gaby Graterol, Mph, Rqap-Gcp Email & Phone Number

Provide overarching CQA Project Support Strategy for Phase II-IV Studies. Activities include: Participation in study risk review discussions, RACT and Central Monitoring Signal Discussions, Review and provide input into key study documents (i.e. Deviation Plan, TMF Plan, etc.), Review/evaluate Vendor Quality Issues, Provide GCP consulting on compliance issues, SQIs, etc. as needed, attend meetings as Key member at Core Team and Study team meetings, development and execution of the CQA Project Oversight Strategy, perform Risk assessments to develop audit strategy, lead inspection readiness activities throughout course project, including development of the pathway to approval and conduct review of study documents.

Sunnyvale, California, Us

Somerset, New Jersey, Us

Primary responsibility is focused on evaluating and securing quality, compliance, and auditing activities which ensure compliance of clinical research operations with corporate policies, industry standards, and applicable regulations (e.g., 21CFR 50, 54, 56, 312, 812, 814, MDR, GCP, etc) by conducting audits of Terumo sponsored clinical research projects, processes, and vendors used to support clinical trials. To support the primary responsibility of the job, I was:- Responsible for developing an internal and external vendor auditing infrastructure, scheduling, conducting, and reconciling clinical research related audits. - Support and lead FDA BIMO investigations. - Develop and implement Clinical Risk-based Quality Management, including Clinical Issue Management. - Report compliance metrics to executive leadership teams, and support the TMC Quality team as needed. - Act as primary CQA representative for assigned Clinical Research projects and assist upper management in mentoring auditors, reviewing and resolving audit reports, and recommending improvement strategies.

Minato-Ku, Tokyo, Jp

Responsibilities include overall operational planning and activities for the execution of clinical investigations and analytical investigations designated as validation studies in the clinical affairs department, including supervision of staff. Essential Functions are:• Manage the clinical tasks and project timelines for departmental activities related to clinical studies, regulatory clearances / approvals, and contractual agreements.• Ensure all clinical operational tasks are completed in accordance with departmental plans and in compliance with standard processes, policies and procedures.• Responsible for vendor management and qualification of third-party suppliers, and review clinical site qualifications, including site qualification visit reports.• Development and authoring of SOPs.• Acts as Risk expert and facilitator for the Risk Management of Clinical Trials in accordance with ICH GCP E6 R2 Section 5, and representative for Clinical in product design Risk Management.• Identifies opportunities for operational continuous improvements and resource utilization using Six Sigma, Lean and Agile basic principles and manage the required changes throughout the department.• Develops, tracks and analyzes operational and staff performance metrics.• Support in forecasting and budgeting for clinical studies.• Authoring of Data Management Plans. • Coordinate data management reviews, health outcome reviews and medical decision points review meetings.• Manage staff, facilitates training and develops internal training programs with external consultants.• Interacts with all levels of departmental personnel as required to manage the coordination of efforts to support milestone achievement and overall project delivery.

Philadelphia, Pennsylvania, Us

Duties include but are not limited to:REGULATORY:• Preparing 510(k) regulatory applications and 510(k) letters to file and secure/maintain marketing approvals for device or manufacturing changes as needed. • Preparing Design Dossiers and Technical Files according to MDD 93/42/EEC and secure/maintain marketing approvals for device or manufacturing changes as needed. • Supporting Rest of World submissions in India, Korea, Japan, China, Canada, Australia, NZ, among others.CLINICAL:• Managing and assisting as CRA and CRC for multiple clinical studies/trials that the Company conducts. • Work with CRO and other outside suppliers for the data management and statistical analysis of clinical data.• Managing documents for International Review Board/Competetent Authority/ Ethics Committee submission and supervising the submission process from submission until approval.• Preparation of Clinical Investigation Protocols (CIP), Investigator Brochures (IB) and Case Report Forms (CRFs) for clinical studies.QUALITY:• Creation and maintenance of SOPs and other core regulatory, quality ,and clinical documents.• Managing of the Complaint Handling System, Non- Conformances and corrective and preventive actions (CAPA). • Conduct and assist with internal and external quality and regulatory audits.

South Jordan, Utah, Us

Key responsibilities/essential functions include such areas as regulatory procedure documentation, standards compliance, and metrics development and implementation. Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions 510(k)s and post-market reporting through the development, maintenance and improvement of documented processes as well as the support of current certification and foreign regulatory document renewals in regions such as Canada, EU, China, Japan, Australia, New Zealand, Turkey, Taiwan, Saudi Arabia and Latin America. 510(k)s experience involves the compiling and sorting of the bulk documentation and support throughout the lifecycle of submission. Drafting of FDA correspondence and Letters to File, as well as supporting the inclusion and maintenance of validation tests, design controls and biocompatibility reports of current 510(k)s. Support regulatory inspections as required, work closely with regulatory, engineering, marketing, legal, and other professionals across the company to communicate company-wide programs and processes for regulatory compliance. Collect & summarize performance metrics to identify program weaknesses & recommend improvements in procedures or oversight.

During my time in this assignment essential functions included learning about regulatory procedure documentation, complaint handling, standards compliance, and metrics development and implementation. As part of the Complaint Handling Unit (CHU), I was trained on complaint triage and analysis for investigation designations. And after the investigations were performed, all paperwork to close-out complaints were under this position responsibilities. Position included training on regulatory compliance and optimization of quality system procedures. First introduced to 510(k)s and post-market reporting through the development, maintenance and improvement of documented processes as well as the support of current certification and foreign regulatory document renewals. 510(k)s experience involved the compiling and sorting of the bulk documentation and support throughout the lifecycle of submission, drafting of FDA correspondence and Letters to File, as well as supporting the inclusion and maintenance of validation tests, design controls and biocompatibility reports of current 510(k)s. Support regulatory inspections as required, work closely with regulatory, engineering, marketing, legal, and other professionals across the company to communicate company-wide programs and processes for regulatory compliance.

Master Of Public Health (M.P.H.), Health Policy Analysis

Executive Women In Leadership Certificate

Post-Baccalaurate, Pre-Medicine/Pre-Medical Studies

Bachelor Of Science, Biology (Pre-Med Studies Track)

Bachelor Of Science (B.S.), Pharmacy