Karen Everett Email & Phone Number

Dublin , Gb

Works in partnership with scientific, operational, clinical, business and technology stakeholders to manage the global supply chain of clinical and/or ancillary supplies in support of phase I-IV clinical trials.• Acts autonomously in the management of end-to-end clinical supply chain logistics for high complexity clinical studies.• May provide support in managing clinical supply logistics at the program level.Develops and assists in the selection of appropriate supply forecast models for high complexity studies.• Coordinates the procurement activities for investigational product, comparator, and other NIMP and/or ancillary supplies for high complexity studies.• Interprets relevant protocol information to develop packaging/labeling design for high complexity studies,• Supports design and set-up of IVRS system for high complexity studies.• Coordinates the origination, proofing and transition of clinical study labels for high complexity studies.• Manages drug supply delivery timelines with appropriate stakeholders.• Prepares required documentation and facilitates activities for import and export of clinical supplies.• Acts as primary point of contact in communication with all stakeholders to ensure adequate quantity and timely delivery of clinical supplies throughout duration of a trial.• Monitors and manages retest dating for assigned study supplies.• Resolves clinical supply complaints and addresses supply replacement requests, as required.• Works closely with appropriate stakeholders to manage clinical supply forecasting and budget requirements for global studies.• Serves as subject matter expert (SME) in managing clinical supply activities.• Trains and mentors junior clinical supply team members.• Leads discussions or work streams to develop process efficiencies.

Venlo, Limburg, Nl

Works with internal teams, 3PL’s, and external vendors to secure availability of products, solving issues that arise in the transfer of health instruments between global locations. Responsible for expediting customer requests and purchase orders globally with focus on the Americas. Duties include the coordination of demo instruments and managing the logistics and refurbishing process as well as regional inventory management according to demand planning and forecast. Exhibits proficiency in SAP and Salesforce software for both order fulfillment and inventory management. Responsible for logistic related improvements and adjustments for North and Central America. Facilitates team collaboration while working independently in remote environments both in the United States and internationally. Chair of QIAGEN’s North American Sustainability Committee which ensures sustainable business practices across local offices in North America, educates employees on sustainability contributes to reducing QIAGEN’s environmental footprint, and works with global sustainability teams to align efforts including Green purchasing criteria and plastic reduction in transportation packaging and products.

Venlo, Limburg, Nl

Working with internal teams and external vendors to secure availability of products, solving issues that arise in the transfer of health instruments between global locations. Responsible for expediting customer requests and purchase orders globally with focus on the Americas. Duties include the coordination of demo instruments and managing the logistics and refurbishing process. Responsible for logistic related improvements and adjustments for North and Central America.

Trains, supervises, schedules workload for and evaluates technicians who conductsubchronic, chronic, dermal and continuous infusion studies using rodents and rabbits. Writes and revises SOPs for the department.•Facilitated start up of a new facility in Chandler, Arizona as the interim Inlife Operations supervisor for three months involving coordinating validation studies, and acquiring appropriate instrumentation and supplies while simultaneously supervising cross-site staff and onboarding the new permanent supervisor. The addition of this facility expanded the company’s capacity and provided greater access to our west coast clients.•Worked on a Six Sigma Kaizen for workload capacity and scheduling at the Drug Discovery site in Greenfield, Indiana and served as a subject matter expert in short turnaround scheduling. The Kaizen resulted in implementing a consistent and robust master scheduling computer system allowing visibility of workload across the company.•Managed a Six Sigma Green Belt project involving mouse cage damages and repairs, reducing the need to purchase new mouse cage racks and the cycle time to replace damaged cages. Labor and supply savings were $24,000 per year.•Collaborated with a Six Sigma Black Belt to generate a departmental value stream mapping of processes from study award to Day 1 study start. This project resulted in optimization and efficiency opportunities at the Vienna, Virginia site which were also leveraged to multiple sites.•Focused staff on work accountability which decreased reportable errors in 2009 within the team by 65% compared to 2008. The lab team also decreased its audit citation rate by 20% compared to 2008.

Wrote protocols and amendments ensuring compliance with appropriate SOPs, GLPs, and regulatory agency guidelines; initiated costing and scheduling of studies; monitored inlife portions of the studies; provided technical/scientific guidance and leadership to ensure accurate project completion; met with clients to discuss study progress; and wrote and reviewed reports.• Specialized in transgenic mouse toxicology and cGMP studies and was the sole toxicologist for all provided study designs such as 1 week, 13 week and 26 week transgenic studies in rasH2 or p53 mice, cGMP mature and hypophysectomized rat weight gain bioassays, and cGMP immunogenicity assays in rabbits.• Developed strong client relationships founded on technical expertise, communication skills and validating clients requirements; in addition to performing client facing duties for fellow toxicologist who were out of the office.• Executed archival of over 100 completed cGMP studies which were contingent on information from the client and worked closely with the client to ensure all future studies could be readily archived upon completion.• Served as a mentor in the Covance Mentoring Program, counseling two mentees, as well as facilitating classes such as “Take Charge of Your Career” and “Signature Client Service”.

Collected, documented and reviewed pertinent data, including animal observations, testmaterial preparation / administration and clinical sample collections all while ensuringthat studies comply with appropriate SOPs, GLPs, and regulatory agency guidelines. Actedas back-up to supervisor for study scheduling and assessing workload capacity.* Composed and revised SOPs for new procedure development and trained less-experiencedstaff which resulted in greater compliance, efficiency, and productivity.* Facilitated a cGMP FDA inspection and client tours in the absence of the teamsupervisor. The FDA inspection resulted in no regulatory violations on a Form-483 and thetours increased our clients' knowledge of our department's capabilities and resources.* Participated on a collaborative client focused Six Sigma project to determine rootcauses for an unusual trend of cGMP Out of Specification results. The resultingimprovements led to a reduction of rework, an increase in client confidence, and anincrease in revenue for both Covance and the client. Additional study awards anddedicated study rooms led to a profit of $427,187.

Collected and documented pertinent data, including animal observations, test materialpreparation and administration and clinical sample collections.* Assisted in data and technique transfer of a cGMP study design from a client's in-houselab to Covance allowing Covance to provide all stability and product-release testing forthat client's product in the United States of America.* Learned and expertly performed all study tasks on a wide variety of study designs whilegenerating on-time quality data.* Promoted from Study Technician I to Study Technician II in 2001 and to Study TechnicianIII in 2002.

Bs, Animal Physiology

Bachelor Of Science, Biology

Education record