Deborah Struller Email & Phone Number

New Jersey, United States

Basel, Baselstadt, Ch

Program Manager leading the design, implementation, and maintenance of a global training programs for regulatory and compliance-based training. • Project manager for roll-out of new role-based training model for all pharma associates to ensure qualification of responsible roles and limit training burden.• Ensure effective measurement of training to demonstrate employees are properly trained to perform their roles. • “Training Factory” Lead successfully delivering regulatory and compliance-based training programs including coordination and activities between SOP and Training offices for Process & SOP packages, Quality Systems, Curricula design, etc., according to timeline and budget specifications.• Appointed member of SOP & Training Governance Board (STGB) to represent DevQA Training. • Manage multiple venders and internal stakeholders ensuring budget and timeline adherence, issue resolution or escalation as required.• Business Partner with Chief Medical Office, Patient Safety and Clinical group to drive the development of annual Quality Training Plan.• Review line function specific training to ensure regulatory and compliance training efforts as defined through SOP and QA guidelines.

Global trainer for clinical and non-clinical programs through system demonstration in groups, individual, and webcast sessions. Designed and managed lessons, instructional modules, and other training documentation.• Participated in role-specific training delivered to approx. 6,000 total employees globally.• Created and shared Enhanced Release Notes to communicate user-friendly CTMS updates, ensuring compliance and readiness for upgraded system globally.• Appointed to represent Training group in Operation Level Agreement (OLA) model designed to enhance collaboration of Training, Process, and Systems landscape.• Designed, developed, implemented Trainers’ Forum, encouraging teamwork and knowledge sharing among trainers.• Delivered Project Management training, customized for organization’s clinical study teams.• Initiated communications with Support and Process groups to ensure consistent messages were conveyed to CTMS user community.• Conducted User Acceptance Testing (UAT) for multiple new releases of CTMS to support system enhancements.

Switzerland 🇨🇭 , Ch

Performed as Lead CTMS Deployment Coordinator for all Pharma Development teams in US to roll out new Clinical Trial Management System to approx. 1,000 users globally. Selected to participate in global Deployment Coordinator workgroup to prepare for deployment events to create synergies and best practices between the two departments. Acknowledged as CTMS Expert User for pilot study team. • Rolled out new Clinical Trial Management System to approx. 1,000 users globally.• Conducted and coordinated CTMS Awareness sessions for all US Product Development divisions.• Managed 30 Deployment Coordinators globally to ensure consistency and timeline challenges were met.• Led CTMS segment of monitor workshop by developing and implementing training kit, including activities, skits, tools and refresher training to further enhance understanding of new system.• Facilitated New Employee Orientation, managed in-house faculty members by identifying their strengths and encouraging participation in sharing knowledge and experience with new affiliate employees.• Created RACI charts for Orientation Manager and CTMS Deployment to ensure transparency of responsibilities.

Proactively provided training and support of systems used to track the progress of clinical trials. Super User for CTMS, AIMS, Electronic Confidentiality Agreement, InTouch, Clinical Documentation Center. Conducted group, virtual and desk-side training and support. • Won Director’s Excellence Award (out of approximately 340 candidates) by creating interactive training program to bridge gaps of knowledge between Functions and Study Teams, initiating and leading Strategic Training Program workgroup to continuously monitor and update program and encouraging experienced colleagues to participate in program. • Reviewed documents for compliance during FDA on-site inspection.• Mentored new hires to help provide smooth transition into new role.• Worked with CTMS Business Team to set up templates, test and train on Standard Operating Procedures related to Clinical Documentation Center for Compliance approval.• Presented new CTMS system in organizational meetings to help boost employee confidence, morale and encourage change.

Liaised between in-house team and field clinical trial monitors to manage clinical trial site activities, including assisting with recruitment efforts, updating study-specific systems, reviewing and tracking regulatory and site documentation, attending meetings and teleconferences as member of US Affiliate Team supporting global Clinical Trials. Participated in several workgroups, ensuring consistency with other study teams, while sharing best practices. • Created and led Functional Team, planning topics and activities for monthly meetings to engage peers and share best practices.• Created and presented new Patient Recruitment Tool Kit for Virology study, including educational tools, for management of recruiting challenges.

Managed and led three Change Control Teams to successfully ensure compliance including Analytical, Assembly, and Outside Contractor Change Control. • Established, and led Analytical Change Control team that ensured change documents were accurate and completed for FDA inspections.• Wrote Standard Operating Procedures for analytical change control. Trained employees and FDA on SOP.• Performed as acting Chair for Manufacturing and Global Change Control Teams

Processed documents through new electronic documentation program (Master Control) for start-up medical device company. Trained employees on new policies, procedures and specifications.•Developed and implemented policies, procedures, and work instructions that established foundation for processing and storage of documentation.• Contributed to successful achievement of ISO 9002 certification on initial assessment.

B.A., Business, Individualized Studies

A.A.S. Degree In Applied Science, Legal Major

Instructional Design