Gary M. Bufferd, Ccra Q-Iaocr Email and Phone Number
Accomplished Clinical Operations and Training Professional | Internationally Qualified Clinical Research Trainer (Q-IAOCR) | Certified Clinical Research Associate (CCRA) | Expert in ICH GCP and International Regulations at
@
BioNTech SE
Gary M. Bufferd, Ccra Q-Iaocr's Location
Tucson, Arizona, United States, United States
Gary M. Bufferd, Ccra Q-Iaocr's Contact Details
Gary M. Bufferd, Ccra Q-Iaocr work email
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Gary M. Bufferd, Ccra Q-Iaocr personal email
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About Gary M. Bufferd, Ccra Q-Iaocr
SELECTED HIGHLIGHTS & SKILLS:Over 25 years’ industry experience working with Sponsors, CROs, and Investigational Sites (as a CRA, Lead CRA, CRA Manager, Clinical Team Leader, Corporate/Clinical Trainer, Associate Director, and Director), with a consistent record of completing all deliverables in compliance with regulatory guidelines, company SOPs, quality expectations, and established metrics.In depth knowledge of, and skill applying, ICH GCP and clinical research regulatory requirements across multiple therapeutic areas and all phases of clinical development (including Phase 1 pharmacology studies, controlled substance studies, and decentralized clinical trials). Technical proficiency with myriad clinical trial systems and applications (including CTMS, EDC, eTMF, eSource, eConsent, IxRS, and ePRO), as well as various LMS platforms and eLearning development applications (Articulate 360 and RISE).Skilled at creating constituency amongst internal/external stakeholders, and across all levels of a global organization.Adept at demonstrating the value of, and implementing strategies to improve operational processes, customer service/quality, and employee engagement/retention.Experienced trainer/presenter for diverse customers and audiences (both internal and external), including presentations at industry meetings (ACRP and DIA).Certified Clinical Research Associate (CCRA) - Association of Clinical Research Professionals (ACRP)Internationally Qualified Clinical Research Trainer Certification (Q-IAOCR) - International Accrediting Organization for Clinical Research (IAOCR)Strengths & Talents:- Training delivery (ILT and vILT)- Instructional design (ADDIE model)- Coaching and mentoring- Developing and implementing employee engagement and retention strategies- Creating tools, resources, and processes to optimize performance and quality- Building relationships and fostering collaboration across teams/departments/regions- Presenting to diverse audiences (internal/external, global)- Exceptional communication skills- "Can Do, I Own It" attitude
Gary M. Bufferd, Ccra Q-Iaocr's Current Company Details
Biontech Se
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Accomplished Clinical Operations and Training Professional | Internationally Qualified Clinical Research Trainer (Q-IAOCR) | Certified Clinical Research Associate (CCRA) | Expert in ICH GCP and International Regulations
Gary M. Bufferd, Ccra Q-Iaocr Work Experience Details
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Director, Clinical Operations Training Management - Biontech UsBiontech Se Jan 2023 - PresentMainz, Rhineland-Palatinate, De
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Associate Director, Learning Program Consultant (Parexel Academy)Parexel May 2022 - Dec 2022Durham, North Carolina, UsSupported the growth and execution of Parexel Academy (PA) training programs and initiatives (regionally and globally) for internal and external clients. Partnered with Clinical and Commercial Operations leaders and clients to support growing PA’s revenue through the application of existing solutions and the development/implementation of new solutions. Accountable for managing program consultation, design, development, implementation, and evaluation, as well as managing the development of PA’s program portfolio to serve business and market needs. Key responsibilities and accomplishments included:▪ Supported the development and delivery of functional, role-based training for entry-level Parexel CRAs.▪ Contributed to the development of enterprise-wide training on Good Clinical Practice (GCP).▪ Supported the development and delivery of GCP training for research-naïve Investigators.▪ Partnered with a Top 10 pharma company to develop an interactive “Training & Career Journey” for Global Clinical Operations staff.▪ Led the development, delivery, and maintenance of a Study Coordinator training program for a large, US-based clinical research site network.▪ Supported the bid defense process by evaluating client RFPs, contributing input to proposals, and attending bid defense (and other exploratory) meetings.▪ Assisted with various business development, client management, performance consulting, and program management activities. -
Director, Clinical TrainingLightship Aug 2021 - Apr 2022El Segundo, Ca, UsNOTE: Lightship implemented workforce reduction measures on 20Apr2022 where 15-20% of employees were terminated (not due to performance), and my role was impacted.Collaborated with Executive/Senior Leadership Teams, Cross-Functional Leads, Project Managers, Clinical Study Teams, Technology Department, Sponsors, and other internal/external stakeholders to develop and implement comprehensive training programs necessary to meet organizational business needs and study-specific requirements. Key responsibilities and accomplishments included:▪ Development, delivery, and maintenance of a Clinical Project Manager training program that focuses on the skills and competencies needed to effectively oversee the conduct and delivery of decentralized clinical trials (DCT).▪ Established learning and development strategies for Clinical Operations personnel (Clinical Directors, Project Managers, Study Coordinators, Research Nurses, Clinical Research Associates, Study Start-Up Associates).▪ Developed, delivered, and maintained training programs, plans, and materials.▪ Developed and maintained a clinical training matrix, and ensured Clinical Operations personnel were compliant with applicable training requirements.▪ Maintained training documentation for Clinical Operations personnel to ensure inspection/audit readiness.▪ Evaluated training needs and knowledge gaps, then developed additional training initiatives/processes/activities, as appropriate.▪ Identified and collaborated with internal/external consultants and vendors on training initiatives and projects.▪ Evaluated Learning Management Systems (LMS) and developed a business case proposal for the implementation of a new LMS solutions.▪ Enhanced the onboarding process and new hire experience by developing an onboarding and training roadmap for all new Lightship associates (across functions). -
Principal TrainerSyneos Health Jan 2018 - Jul 2021Morrisville, Nc, UsPrimary responsibilities and accomplishments included:▪ Development, delivery, and maintenance of a global Clinical Lead (Lead CRA) training program that focuses on the competencies needed to effectively and consistently drive clinical study conduct and delivery. This robust training program, which earned a 5-star accreditation from IAOCR as part of an independent quality assurance process, comprises five vILT sessions as well as prerequisites and post-session assignments (including submission of learning evidence reviewed and critiqued by instructors). ▪ Development, delivery, and maintenance of a report review curriculum that provides learners with a strategy and skills for reviewing monitoring reports and providing feedback to report authors. ▪ Development and maintenance of a self-paced training course on site and subject-level non-compliance (created with Articulate Storyline). ▪ Development and delivery of recurring vILT sessions on topics related to ICH GCP fundamentals. ▪ Development and maintenance of a harmonized learning evaluation (Kirkpatrick’s Levels 1-2) for use across all functional training areas (self-paced courses and instructor-led classes), along with a metrics template to help analyze the data. ▪ Served as workgroup leader on the development of job aids to support Clinical Leads assigned to projects scoped for RBM, as well as other process improvement initiatives (e.g., the development of a harmonized learning evaluation and a departmental guideline on version control of training materials). ▪ Served as Clinical Training Liaison for the development and maintenance of company SOPs/WIs (and other controlled documents) used globally across all BUs for site monitoring and management. ▪ Contributed significantly to the harmonization of clinical training classes/courses with the merger of legacy organizations (INC Research and inVentiv Health). -
Principal TrainerInc Research Aug 2016 - Dec 2017Raleigh, North Carolina, UsLed and was involved in the development, delivery, evaluation, and continuous improvement of the training curriculum to ensure alignment to the Company's business goals and needs. Served as a training leader to a functional until, department, or business unit within the Company and provided oversight to specific core training departmental function or applications. Led targeted initiatives such as a tactical work group or other ad hoc corporate initiatives. Mentored less experienced employees. -
Associate Clinical Lead DirectorQuintiles May 2016 - Aug 2016Durham, North Carolina, UsServed as a member of the core project team and partnered with the Project Leader to ensure overall project meets delivery requirements. Responsible for running large, multi-regional studies and managing the operational aspects of projects to meet contractual requirements and in accordance with SOPs, policies and practices. Represented clinical delivery with customer. -
Clinical Team Leader (Cns Business Unit)Inc Research Jun 2014 - May 2016Raleigh, North Carolina, UsServed as a Functional Lead for Clinical Operations with full responsibilities for clinical monitoring (across 8 countries and 90 sites) and line management of Clinical Research Associates in all regions. Served as a core member of the project's Leadership Team. Ensured appropriate communication, regulatory documentation, and ongoing oversight. Provided support for business development.Responsible for the review of the study scope of work, budget, and protocol content. Provided training to project team on protocol, CRF completion, Sponsor SOPs, clinical plans and guidelines, and timelines for the study. Responsible for the development of the Clinical Monitoring Plan, annotated visit reports, and other CRA tools and resources. Reviewed and approved site visit reports. Lead bi-weekly project calls with CRAs. Responsible for site assignments for CRAs. Ensured study specific training requirements were completed and documented.Responsible for the supervision and administrative oversight of CRAs. Developed training plans and ensured training compliance for all direct reports. Evaluated strengths/developmental opportunities of staff members. Set clear goals and objectives for all direct reports. Completed performance reviews and implemented performance plans. Ensured CRA metrics were met.
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Associate Director, Corporate Training & Employee EngagementResearch Pharmaceutical Services (Now Part Of Pra) Jan 2013 - Nov 2013Fort Washington, Pa, UsIn addition to retaining all key responsibilities and duties from the “Clinical Client Liaison” role (as described below), developed and implemented a global management training program across regions and departments. Directly supported the Executive Leadership and Global Management Teams by proposing and implementing solution-driven ideas to optimize customer service/quality and increase employee engagement/retention.▪ Created a comprehensive training program and resource manual for Managers, which covered various content areas ranging from administrative procedures to management best practices.▪ Served as company SME on employee engagement/retention and collaborated with Executive Leadership and Senior Management to remediate issues and implement strategies to strengthen engagement and reduce turnover. -
Associate Director, Clinical Client LiaisonResearch Pharmaceutical Services (Now Part Of Pra) Mar 2011 - Jan 2013Fort Washington, Pa, UsCollaborated with Executive Leadership and Sr. Management (Research Operations) to identify and remediate internal/external operational issues and deficiencies. Promoted and facilitated change management in order to optimize customer service and quality. Implemented strategies to drive process improvements and increase employee engagement and retention. ▪ Co-developed and maintained a mandatory training module for all new employees (globally), as an introduction to RPS and to educate new staff about the company’s mission/vision, business model, and strategic goals.▪ Wrote and distributed weekly communications to Management with specific tips and strategies to help increase employee engagement/retention across the entire global organization.▪ Established/acted as Chairperson for the “Turnover Mitigation & Career Advancement Committee” (a global team of Research Operations Directors & Managers, with collaboration from Global HR and Training & Development).▪ Proposed and co-developed the “Learning Community for Clinical Operations Managers” (a forum in which Managers across business units were provided with information and resources to increase managerial effectiveness), planned/facilitated meetings, and built/managed (as site administrator) an associated SharePoint site.▪ Designed large-scale employee surveys, collected/analyzed data, reported findings to internal/external stakeholders, and proposed/implemented strategies in response to feedback.▪ Created management tools and resources on various topics, including on/off-boarding employees, succession planning, conducting stay interviews, and handling employee resignations.▪ Developed and delivered training sessions on various topics, including employee engagement/retention, managing remote employees, and working on global virtual teams.
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Clinical Research Associate IiiResearch Pharmaceutical Services (Now Part Of Pra) Jul 2010 - Feb 2011Fort Washington, Pa, Us
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Clinical Research ManagerResearch Pharmaceutical Services (Now Part Of Pra) Jan 2010 - Jun 2010Fort Washington, Pa, Us
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Regional Clinical Research AssociateResearch Pharmaceutical Services (Now Part Of Pra) Jan 2008 - Dec 2009Fort Washington, Pa, Us
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Regional Clinical Research AssociateResearch Pharmaceutical Services (Now Part Of Pra) Mar 2003 - Jun 2005Fort Washington, Pa, Us
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Regional Medical Research AssociateBayer Feb 2001 - Mar 2003Leverkusen, North Rhine-Westphalia, De -
Clinical Monitoring CoordinatorMcghan Medical Corporation (Now Part Of Allergan) Oct 2000 - Dec 2000Dublin, Coolock, Ie -
Regional Clinical Associate IiWyeth-Ayerst Research (Now Part Of Pfizer) Mar 1999 - Oct 2000New York, New York, Us -
Senior Clinical Research AssociateAllergan Jun 1998 - Mar 1999Dublin, Coolock, Ie
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Clinical Research AssociateQuintiles Mar 1997 - May 1998Durham, North Carolina, Us
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Clinical Research Assistant IiQuintiles Jul 1996 - Feb 1997Durham, North Carolina, Us
Gary M. Bufferd, Ccra Q-Iaocr Skills
Ich Gcp
Cro
Employee Engagement
Training And Development
High Performance Teams
Clinical Research
Ctms
Mentoring
Employee Recognition
Management Training Programs
Talent Management
Innovation
Cns/psychiatry
Training And Compliance
Pharmaceuticals
Clinical Monitoring
Employee Relations
Strategic Leadership
Clinical Development
Edc
Succession Planning
Fda Regulations
Etmf
Strengthsfinder
Research
Controlled Substance Studies
Engaging Public Speaker
Services
Employee Tr
Neuro/pain
Staff Retention
Performance Management
Conference Presentations
Gary M. Bufferd, Ccra Q-Iaocr Education Details
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Indiana University BloomingtonPsychology (Major); Sociology & Music (Minors) -
Staples High School (Westport, Ct)H.S. Diploma
Frequently Asked Questions about Gary M. Bufferd, Ccra Q-Iaocr
What company does Gary M. Bufferd, Ccra Q-Iaocr work for?
Gary M. Bufferd, Ccra Q-Iaocr works for Biontech Se
What is Gary M. Bufferd, Ccra Q-Iaocr's role at the current company?
Gary M. Bufferd, Ccra Q-Iaocr's current role is Accomplished Clinical Operations and Training Professional | Internationally Qualified Clinical Research Trainer (Q-IAOCR) | Certified Clinical Research Associate (CCRA) | Expert in ICH GCP and International Regulations.
What is Gary M. Bufferd, Ccra Q-Iaocr's email address?
Gary M. Bufferd, Ccra Q-Iaocr's email address is gb****@****ast.net
What schools did Gary M. Bufferd, Ccra Q-Iaocr attend?
Gary M. Bufferd, Ccra Q-Iaocr attended Indiana University Bloomington, Staples High School (Westport, Ct).
What skills is Gary M. Bufferd, Ccra Q-Iaocr known for?
Gary M. Bufferd, Ccra Q-Iaocr has skills like Ich Gcp, Cro, Employee Engagement, Training And Development, High Performance Teams, Clinical Research, Ctms, Mentoring, Employee Recognition, Management Training Programs, Talent Management, Innovation.
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