Beth Werner Email & Phone Number

Nashville, Tn, Us

Morrisville, Nc, Us

Princeton, New Jersey, Us

Thompson Station, Tennessee, Us

 -Evaluate staff training needs and assist in training and development; mentor staff as needed. -Participate in employee recruitment procedures as needed and performance based assessments. -Ensure proper conduct of daily activities in compliance with applicable protocols, FDA regulations, ICH/GCP guidelines, appropriate company and/or client SOPs, and professional standards. -Provide support to project managers and clinical monitoring teams for day-to-day study conduct (e.g. creation of study-related documents, processing investigator payments, etc.). -Ensure investigational research sites have adequate study supplies and project-related tools. -Assist with developing, assembling, and shipping Study Reference Manuals to investigational research sites (if applicable). -Supervise/assist in the collection and review of initial and ongoing regulatory documentation for submission to appropriate Medelis or client regulatory representatives. -Update any project databases or tracking spreadsheets as necessary. -Participate in required project-specific teleconferences or face-to-face meetings. -Participate in protocol-specific training and other developmental activities. -Participate in business development activities as needed. -Promote teamwork.

Princeton, New Jersey, Us

 -Lead core project team during start up phase and facilitate team’s ability to lead extended/complete project team. -Ensured effective cross-functional teamwork among project team members including both internal and external ancillary services. -Served as escalation point for project issues and resolve conflicts as needed. -Monitored project schedule and scope to ensure both remain on track. -Accountable for budget across assigned project(s) including the control and minimizing of write-offs. Proactively identify out-of-scope activities and ensure necessary change orders are executed. -Presented at external and/or internal meetings. -Defined and manage project resource needs and establish succession plans for key resources. -Created required project plans and implement and monitor progress against the plans and revise as necessary. -Served as key client contact for assigned projects. -In collaboration with relevant departments, prepared and delivered presentations for new business as required. -Line management responsibilities for the training, utilization, development and performance review of assigned staff. -Contributed to development and management of client project metrics. -Performed other duties as assigned by management

Princeton, New Jersey, Us

 -Responsible for the management of site start-up activities -Worked with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organizations to develop evidence-based plans for the successful implementation and conduct of global clinical trials. -Supervised GSS staff in performance of their day to day work, including management of resource allocations. -Provided logistical support for clinical trial supply coordination. -Provided GSS input into business development activities. -Direct line management responsibility for GSS team members: the recruitment, training/development, allocation, supervision, utilization and performance review of assigned personnel. -Lead global project teams and global department members regarding issues of compliance with ICH/GCP, project plans, and Covance SOPs. -Fulfilled the role of start-up manager and oversee coordination of study activation components of the project from an oversight level including Feasibility, Site Selection, Site Activation, Labels/Supply, Regulatory Submission, Green Light. -Prepared, or had input into, project specific plans. -Anticipated and monitored project requirements and instituted appropriate actions to ensure timelines and budget needs were met. -Assisted in the preparation and presentation of services, costings and proposals for new business. -Management of GSS portion of project budgets. -Supervision of Investigator Package review and approval prior to drug shipment. -Clinical trial supply coordination including: providing consultation pertaining to clinical supplies (labeling, tracking, specific national requirements); ensure triggering of drug shipments to investigational sites; manage drug distributor; supervise development and review of Clinical Trial Supplies Plans. -Developed, updated and/or refined SOPs. -Performed other duties as assigned by management.

Thompson Station, Tennessee, Us

 -Supervised Project Coordinators and other assigned staff; promote team work, and resolve conflicts as needed. -Evaluated staff training needs and assisted in training and development; mentored staff as needed. -Participated in employee recruitment procedures as needed and performance based assessments. -Participated in development of project management SOPs and processes. -Ensured proper conduct of daily activities in compliance with applicable protocols, FDA regulations, ICH/GCP guidelines, appropriate company and/or client SOPs, and professional standards. -Provided support to project managers and clinical monitoring teams for day-to-day study conduct (e.g. creation of study-related documents, processing investigator payments, etc.). -Ensured investigational research sites had adequate study supplies and project-related tools. -Assisted with developing, assembling, and shipping Study Reference Manuals to investigational research sites (if applicable). -Supervised/assisted in the collection and review of initial and ongoing regulatory documentation for submission to appropriate Medelis or client regulatory representatives. -Updated any project databases or tracking spreadsheets as necessary. -Participated in required project-specific teleconferences or face-to-face meetings. -Participated in protocol-specific training and other developmental activities. -Participated in business development activities as needed. -Met regularly with Project Managers and Senior Project Directors, to discuss project priorities and allocation of Project Coordination staff. Project Managers will be responsible for managing project timelines and for working with Manager, Project Coordination and Senior Project Director regarding Project Coordination staff allocation.

Thompson Station, Tennessee, Us

 -Evaluated staff training needs and assist in training and development; mentor staff as needed. -Participated in employee recruitment procedures as needed and performance based assessments. -Ensured proper conduct of daily activities in compliance with applicable protocols, FDA regulations, ICH/GCP guidelines, appropriate company and/or client SOPs, and professional standards. -Provided support to project managers and clinical monitoring teams for day-to-day study conduct (e.g. creation of study-related documents, processing investigator payments, etc.). -Ensured investigational research sites had adequate study supplies and project-related tools. -Assisted with developing, assembling, and shipping Study Reference Manuals to investigational research sites (if applicable). -Supervised/assisted in the collection and review of initial and ongoing regulatory documentation for submission to appropriate Medelis or client regulatory representatives. -Updated any project databases or tracking spreadsheets as necessary. -Participated in required project-specific teleconferences or face-to-face meetings. -Participated in protocol-specific training and other developmental activities. -Participated in business development activities as needed. -Promoted teamwork.