Jeff Weber, Pmp Email & Phone Number

Indianapolis, Indiana, United States

In addition to fulfilling global Planview Business Administrator responsibilities, I provide day-to-day direction of staff and manage the Regulated Bioanalytical Client Delivery Team to achieve client and company goals and initiatives. I support direct reports and drive continuous improvement in processes and procedures used by the project team while performing the duties and responsibilities of a Project Manager when needed. To achieve these goals, I perform the current tasks to support my… Show more In addition to fulfilling global Planview Business Administrator responsibilities, I provide day-to-day direction of staff and manage the Regulated Bioanalytical Client Delivery Team to achieve client and company goals and initiatives. I support direct reports and drive continuous improvement in processes and procedures used by the project team while performing the duties and responsibilities of a Project Manager when needed. To achieve these goals, I perform the current tasks to support my team and global project management organization: - Planning, assigning, and directing work, mentoring, and training staff, performance management, including appraising performance and guiding professional development, rewarding and disciplining employees as applicable.- Participate in initiatives to improve employee engagement to positively impact operational results, customer satisfaction and employee retention.- Continuously assess talent within project management and drive consistent, high-quality project management services.- Ensure that studies are planned and executed in accordance with FDA, ICH, and/or EMEA guidelines and that Good Clinical Practices are always followed.- Actively participate or lead external customer meetings with sales as applicable.- Participate in bid defense meetings to drive new and repeat business.- Serve as liaison between Project Services, internal departments, external vendors, and the sponsor during the life cycle of the project(s).- Build and own client relationships for assigned studies and serve as a liaison between Sponsor and project teams.- Represent the company at Investigator/ Monitor meetings, internal and external authorities of regulatory bodies, and other Face to face meetings as needed.- Participate in external and internal audits/inspections, as required.- Report on team performance against contract, client expectations, and project baselines to management. Show less

Indianapolis, Indiana, United States

In addition to fulfilling global Planview Business Administrator responsibilities, I was responsible for the oversight of In Vitro Metabolism study execution as it relates to timelines, data quality, and interpretation of results. Most notably (but certainly not inclusive), I performed the following tasks to ensure successful study execution:- Provided oversight over the performance of tasks associated with the execution of project work to Q2 Solutions’ scientific standards and to the… Show more In addition to fulfilling global Planview Business Administrator responsibilities, I was responsible for the oversight of In Vitro Metabolism study execution as it relates to timelines, data quality, and interpretation of results. Most notably (but certainly not inclusive), I performed the following tasks to ensure successful study execution:- Provided oversight over the performance of tasks associated with the execution of project work to Q2 Solutions’ scientific standards and to the complete satisfaction of the customer.- Assisted in the design, implementation, documentation, and reporting of all project work using appropriate level of regulatory compliance.- Collaborated with clients, external Q2 Solutions divisions, third-party vendors, and In Vitro Metabolism staff on scientific issues for complex projects, scientific principles, and regulatory gap analyses.- Assisted in managing allocation of resources with an eye towards efficiency and quality, including project assignment and capacity management.- Monitored the progress of all assigned projects. Provided regular project status updates to management with alerts if work falls behind schedule.- Participated in scheduling and revenue update meetings and provide updates on project progress. Submitted accurate assessment of resource requirements for scheduling purposes.- Established relationship with clients and maintain communication with customers, providing updates on all active projects while being vigilant for opportunities to earn additional business.- Provided project trackers for client communications and lead regular teleconferences to discuss project progress.- Worked with business development staff to prepare quotes for In Vitro Metabolism services.- Assisted management in formulating and implementing effective strategic initiatives and business development for In Vitro Metabolism services. Show less

Indianapolis, Indiana Area

Served as the Planview Enterprise One business administrator for 5 geographically separated sites (up to 200 licensed users). Actively led configuration activities alongside Planview experts. Developed business rules and documented processes to communicate best-practices to end users. In conjunction with internal IT and the core business team, led user acceptance testing efforts to verify that Planview function met predetermined business requirements. Supported all sites during ambassador… Show more Served as the Planview Enterprise One business administrator for 5 geographically separated sites (up to 200 licensed users). Actively led configuration activities alongside Planview experts. Developed business rules and documented processes to communicate best-practices to end users. In conjunction with internal IT and the core business team, led user acceptance testing efforts to verify that Planview function met predetermined business requirements. Supported all sites during ambassador training and roll-out. Post roll-out, fulfilled all Planview business administrator functions.More broadly, I supported the application of a consistent, methodology-driven approach through management of specific components of projects or sub-projects for Operational Effectiveness Services (OES). This was accomplished by delivering solutions that identify and accelerate operational productivity, optimization and efficiency through change and process improvements within Quintiles. I also participated in process re-engineering, data modeling, Lean Six Sigma and other process/data analysis efforts while monitoring performance improvement through metrics ensuring high quality, timely, on budget deliverables in accordance with relevant SOPs, policies, and practices. Show less

Indianapolis, Indiana Area

- Biological assay development and performance focused on the analysis of xenobiotics in a variety of subcellular liver fractions (hepatocytes, microsomes, etc.) and recombinant (insect-cell expressed) enzyme from human and other preclinical species. These studies are generally performed to determine the role of hepatic enzymes in total drug clearance. This also includes evaluating the potential of a xenobiotic to inhibit or induce hepatic enzymes. - Perform population-based… Show more - Biological assay development and performance focused on the analysis of xenobiotics in a variety of subcellular liver fractions (hepatocytes, microsomes, etc.) and recombinant (insect-cell expressed) enzyme from human and other preclinical species. These studies are generally performed to determine the role of hepatic enzymes in total drug clearance. This also includes evaluating the potential of a xenobiotic to inhibit or induce hepatic enzymes. - Perform population-based scaling to predict in vivo outcomes from in vitro data (IVIVE). - Identify and implement strategies to manage cost or increase process efficiency. - Communicate and maintain scientific relationships with existing and potential clients.- SOP writing, documentation, and quality review in a GLP-like environment. Show less

Indianapolis, Indiana Area

- Biological assay development and performance focused on the analysis of xenobiotics in a variety of subcellular liver fractions (hepatocytes, microsomes, etc.) and recombinant (insect-cell expressed) enzyme from human and other preclinical species. These studies are generally performed to determine the role of hepatic enzymes in total drug clearance. This also includes evaluating the potential of a xenobiotic to inhibit or induce hepatic enzymes. - Perform population-based… Show more - Biological assay development and performance focused on the analysis of xenobiotics in a variety of subcellular liver fractions (hepatocytes, microsomes, etc.) and recombinant (insect-cell expressed) enzyme from human and other preclinical species. These studies are generally performed to determine the role of hepatic enzymes in total drug clearance. This also includes evaluating the potential of a xenobiotic to inhibit or induce hepatic enzymes. - Perform population-based scaling to predict in vivo outcomes from in vitro data (IVIVE). - Identify and implement strategies to manage cost or increase process efficiency. - Communicate and maintain scientific relationships with existing and potential clients.- SOP writing, documentation, and quality review in a GLP-like environment. Show less

- Analytical support and small-molecule method development for individual biologists or project teams (HPLC/MS/MS).- Biological assay development and performance centered around the kinetic analysis of human liver microsomes, recombinant (insect-cell expressed) enzyme, and hepatocytes to determine their role in hepatic drug clearance.- SOP writing, documentation, and quality review in a GLP-like environment.