Douglas Rumberger Email & Phone Number

Schwenksville, Pa, Us

Conshohocken, Pennsylvania, United States

Responsible for the preparation and delivery of training of Instem products & services, sharing in-depth knowledge of training content through instructor led training and on-line training content of Instem University (LMS). Takes lead roles on internal and client facing projects.• Working industry knowledge of Pre-clinical research (GLP focus).• Develop training content for Provantis Applications (PowerPoint, Camtasia, Storyline).• Client Engagement managed project to encourage clients to better use Instem University. • Provantis Consultancy review how software is used and provide suggestions to use better. • Project Management – delivering information and services to a client in a timely fashion.

Conshohocken, Pennsylvania, United States

Provide instructor led training and develop learning content for internal LMS (Instem University). Manage projects including on-site and hosted implementations of Instem software and services including SEND Explorer, software upgrades, and training projects. Other tasks include projecting revenue, invoicing and recognition of revenue.

Conshohocken, Pennsylvania, United States

Serves customers as a specialized educator providing high impact in the accelerated knowledge of the uses of Provantis and other Instem Pre-Clinical products. Returning value to the customers by providing data and IT solutions. • Develop and deliver successful training plans based upon customer's needs• Deliver training in the use of Instem's software solutions• Facilitate customers knowledge and awareness of the value of Provantis and other Instem products.

Served as Subject Matter Expert of Provantis, maintained system compliance with 21 CFR Part 11, and 58. My duties also including troubleshooting issues, serving as liaison between users, IT/vendor support and Regulatory Affairs. Performed internal quality checks of final regulatory reports. Conducted QC audit reviews of tasks, data and final report review of CRO studies.• Improved report documentation by creating options to allow greater transparency of data for Provantis.• Improved Study Director documentation of study ownership by approving technician’s study data changes prior to execution.• Increased department flexibility by training 8 users to perform Provantis Study Management and Data Modification that was previously done by 1 user.• Improved consistency of Provantis study data through training presentations, creation and organization of greater than 60 tip sheets for reference.• Awarded for personal efforts contributing to the validation of Provantis for Reproductive Studies. • Executed a plan to keep Provantis user’s skills sharp prior to the go live date. Due to vendor scheduling. conflicts, users were trained 3 months prior to go live date. Plan provided a smooth transition.• Reduced Quality Assurance findings by assembling and reviewing final study reports.

Managed the day to day of a GLP lab compliant to 40 CFR part 160.for 12 scientists, responsible for the completion and quality of their work. Participated in the hiring process of co-ops and full-time scientists. • Mentored 6 direct reports via monthly meetings, and creating opportunities for development.• Created checklist to improve quality of in-life procedures and end of study data review.• Assumed role of point person to internal Regulatory Affair’s questions and responded to the Facility and Computer System Audits for Corrective and Preventative Actions (CAPA).• Member of a matrix team to complete MicroSoft Word Macro Validation resulting in quicker report formatting saving approximately 3 minutes per file.• Networked with a contract lab regarding best practices for mating Vascular Access Ported (VAP) animals resulting in a savings of animals, many man hours and time by ordering VAP time-mated animals from the vendor instead of training technical staff in natural mating. • Member of a matrix team to complete Gap Analysis, Due Diligence, Business and User Requirements of Provantis during a time when the department was down to one lab supervisor. • Developed strategies with managers to conduct training in needed areas resulting in more skilled and developed technical staff as well as an increase in the department’s capabilities.• Encouraged employee empowerment by coaching technical staff in making decisions.

Managed the laboratory on-line data collection (LIMS) system. Built effective relationships with vendor, IT support, peers and end users.• Presented TFR/Tox refresher training to internal World Wide Regulatory Auditors resulting in a greater understand on how to quality check reports faster and more effectively.• As Report Coordinator was an active participant and lead for a group of 2 that prepared and formatted regulatory reports. Assembled tables, appendices, and created the Common Technical Document (CTD) using applications MS WORD, TAG, Documentum, and IMMS to aid in meeting report deadlines. Report Coordinator save 8-15 hours of Study Director’s time per study.• Created juvenile studies to be collected on TFR/Tox which automated data collection and reporting.

Managed Data Collection System TFR Tox‘s including entering all study set ups (40-60/year), performed all approved data modifications, validations and change controls • Successfully supervised GLP studies to comply with regulatory standards.

• Accomplished Study Supervisor for Pre and Postnatal Studies• Demonstrated a high competency for attention to detail• Panelists of a roundtable discussion on “Laboratory Methods for Evaluation Rat Sperm Motility” at a Middle Atlantic Reproduction and Teratology Association Meeting • Received a Silver Impact Team Award for created the First Safety Assessment Safety Committee • Received a Bronze Impact Award for Validation of Behavior Equipment.• Received a Crystal Impact Award for improving and preventing supply issues for animal ordering.

Demonstrated strong working knowledge of GLP requirements. • Accomplished Study Supervisor for Embryo Fetal Development and Fertility Studies.• Received AALAS Laboratory Animal Technologist Certification – (LATG).• Created Rodent Sperm Morphology Atlas - used as a reference to identify abnormally shaped sperm.