Kyle Daw, Pmp Email & Phone Number

Duluth, Ga, Us

Malvern, Pennsylvania, United States

• Recipient of the Red Nucleus Rising Star 2023 award.• Supported the development and implementation of Veeva Regulatory Information Management (RIM) and Electronic Trial Master File (eTMF) systems for a pharmaceutical client. Ensuring compliance with industry regulations and streamlining regulatory processes and enabling efficient management of clinical trial documentation, enhancing collaboration between stakeholders.• Oversaw and supported the development and implementation of Veeva Quality, Quality Management Systems (QMS), and Safety Vault systems for a pharmaceutical client. Improving overall quality control processes while maintaining compliance to regulatory standards and ensuring secure storage and management of critical safety-related documents and data.• Directed the development of a cloud-based clinical data repository, empowering client statisticians to harness powerful computing for expedited trial data analysis, through strategic planning, team collaboration, and adherence to industry regulations.• Led cross-functional project teams, collaborating with stakeholders to ensure successful system integration and user adoption.• Supported and led the development of procedural documentation, including Standard Operating Procedures (SOPs) and Work Instructions (WIs), ensuring clear guidelines for operational processes and compliance to industry standards.• Developed training documentation to support the adoption of the new processes and procedures that were brought in with the Vault Quality and eQMS environments for a pharmaceutical client.• Designed and delivered engaging Instructor Led Training (ILT) sessions, incorporating interactive activities and real-life examples to promote active learning and ensure trainees' understanding of the new processes.• Implemented dynamic dashboards to provide real-time project status updates to client executive leadership, ensuring informed decision-making and transparency in project management.

Malvern, Pennsylvania, United States

• Mapped process frameworks for various departments, identifying inefficiencies and areas for improvement.• Developed comprehensive training material, including manuals and e-learning modules, to enhance employee knowledge and skills within Veeva Regulatory Information Management (RIM), Electronic Trial Master File (eTMF), and Quality Vaults.• Conducted interviews with executive stakeholders to understand their needs and challenges, resulting in the development of an effective framework for organizational change management.• Created materials to support the adoption of a data lake system for a global organization, ensuring seamless integration and data management.• Mapped the training process for new hires in the patient services department, streamlining onboarding and improving overall employee performance.• Developed next steps for a future state training process, incorporating feedback and recommendations from key stakeholders.

Covington, Georgia, United States

• Recipient of the BD Innovation Award, R&D Excellence Award 2021, and Patent Application Filing award.• Launched a new medical device product in Q1 2021.• Researched and performed experiments with different materials to identify the ideal material type for a new product.• Coordinated the development of product and design specifications based on user needs for a new product.• Coordinated and performed Design Verification trials to verify the design specifications for a new product.• Developed product structures and bill of materials for new products.• Introduced process improvements to a currently marketed medical product to increase yield and reduce cost.

Covington, Ga

• Project Leader of a sustaining engineering (SE) project for a sellable prescription based medical device.• R&D Technical Lead of multiple new product development (NPD) projects that utilized a multitude of different materials (silicone, PVC, TPU, etc.) and production processes (dip molding, injection molding, extrusion, etc.).• Created, coordinated, supervised, and performed the execution of protocols for new and/or improved products and processes across different business units, both domestically and internationally.• Developed test methods, laboratory experiments, protocols, and test reports for the verification of new or improved products and processes.• Experienced with ISO and ASTM regulatory requirements and recording of documentation in compliance with design control processes for medical devices. Performed testing of various product types and reported on results in compliance with GDP, GLP, and GMP standards.• Lab manager of a Class 1, Div. 1 intrinsically safe laboratory that housed and utilized volatile solvents and LSR silicones. Maintained chemical inventory, documentation, routine safety checks, and oversaw experiments conducted in the laboratory.

Covington, Ga

• Worked within a team in the formulation and prototyping of a new product development (NPD) project by identifying and understanding key components of the production process of said product using DOEs.• Coordinated with international production plant members to perform chemical compounding, product production, and post-processing for the development of a new product at scale.• Conducted data analysis using Minitab to understand and present test reports. • Set up, safely operated, and maintained laboratory equipment, chemicals, and test instruments.

Athens, Georgia Area

• Ran bioassays to test the lethality of Bacillus thuringiensis subspecies israelensis (Bti) samples via dilutions on larval black flies.• Quality control analysis of the Bti samples to new samples to compare the lethality on black fly larvae.• Maintained black fly colony; includes feeding, cleaning containers, monitoring water and room temperatures, setting up an oviposition chamber for future generations.• Trained and supervised new employees.