Kimberly Moyer Email and Phone Number

Focused on planning, executing, and closing projects. Management of timelines, resources, and scope to ensure that a project is completed on time and within budget.Risk Management: Identification of potential risks to the project and development of risk mitigation strategies.Monitoring of quality KPI's, ensuring training records are up to date, and leading both internal and client meetings. Working with Financial System Open Air to manage billing, timesheets of study… Show more Focused on planning, executing, and closing projects. Management of timelines, resources, and scope to ensure that a project is completed on time and within budget.Risk Management: Identification of potential risks to the project and development of risk mitigation strategies.Monitoring of quality KPI's, ensuring training records are up to date, and leading both internal and client meetings. Working with Financial System Open Air to manage billing, timesheets of study team resources, invoicing, budget and resourcing. Creating and managing timelines to ensure study deliverables are met. Working with contractual documents, creating & maintaining communication plans, Project Risk Register and study wide documentation. Identification of out of scope work to include in Change Orders and Contract Amendments. Management of the overall project health of the studies. Show less

Managed a sub-set of project-specific activities as directed by the Project Manager to support overall delivery of the project. Compiled and presented status updates to Leadership. Liaised with functional leads to ensure proper financial forecasting and actualization of deliverables, and provided input for the Project Risk Register. Assisted project teams in the early adoption of new systems or processes. Drove team compliance with project-specific requirements;… Show more Managed a sub-set of project-specific activities as directed by the Project Manager to support overall delivery of the project. Compiled and presented status updates to Leadership. Liaised with functional leads to ensure proper financial forecasting and actualization of deliverables, and provided input for the Project Risk Register. Assisted project teams in the early adoption of new systems or processes. Drove team compliance with project-specific requirements; and networks with senior internal and external stakeholders in own area of expertise. Show less

Lead the coordination of compliance and policy due diligence activities for R&D third party engagements ensuring all pre-contract activities are completed prior to contract execution.Ensuring R&D staff, key internal partners/ customers and suppliers are aware of their obligations with respect to all relevant policies, standards and regulations related to outsourcing and/or engaging third parties.Implementation of the R&D third-party risk assessment and management framework that… Show more Lead the coordination of compliance and policy due diligence activities for R&D third party engagements ensuring all pre-contract activities are completed prior to contract execution.Ensuring R&D staff, key internal partners/ customers and suppliers are aware of their obligations with respect to all relevant policies, standards and regulations related to outsourcing and/or engaging third parties.Implementation of the R&D third-party risk assessment and management framework that addresses compliance-focused requirements impacting R&D when engaging with third parties. Show less

• To assess studies for clinical disclosure & patient level data sharing requirements & guide clinical teams through complete, consistent & timely disclosure & listing of studies in scope for public disclosure registries such as GSK/ViiV Clinical Study Registers, Clinicaltrials.gov, EU Clinical Trials Register, EU PAS register & the Clinical Study Data Request (CSDR) website.• Monitor timelines & progress of studies in scope for clinical disclosure & patient level data sharing & report to… Show more • To assess studies for clinical disclosure & patient level data sharing requirements & guide clinical teams through complete, consistent & timely disclosure & listing of studies in scope for public disclosure registries such as GSK/ViiV Clinical Study Registers, Clinicaltrials.gov, EU Clinical Trials Register, EU PAS register & the Clinical Study Data Request (CSDR) website.• Monitor timelines & progress of studies in scope for clinical disclosure & patient level data sharing & report to the rest of the team & management as necessary to monitor compliance • Monitor source system data quality and work with clinical teams towards positive confirmation of critical disclosure components of source data • Work with clinical disclosure support services and other Clinical Governance and Data Transparency teams on timely query resolution• Provide support to the Data Sharing team by coordinating asset clearance, preparation of CSDR study list, locating data and documents and managing offshore provider workload• Identify and be involved in the development of new reports and alerting mechanisms to aid internal decision making • Contribute to the development of procedural documentation including guidance documents and / or instructional documents• Contribute to training material for the business, clinical support services and off shore service provider teams• Follow up with teams when studies are at risk and ensure they meet their critical timelines• Provide support for the third party QC process and ensure that third party QC groups meet their objectives• Work with other Clinical Disclosure Lead(s) and other Clinical Governance and Data Transparency team members to identify issues and work on process improvements when relevant• Provide adequate oversight of all disclosure activities performed by offshore service providers• Monitor the quality of information posted by GSK to public websites and identify and address any quality issues Show less

CRF Submissions: Deliver subject CRFs to support R&D Regulatory submissions and ad-hoc requests;Project Management oversight of TCS and liaise with Regulatory, Publishing & Submission Managers to ensure timely delivery and meet timelines for FDA submissionsFinancial Disclosures:Review reports TCS generates for FDA submissionState Sanctions: Implement and support a standardized program for addressing state sanctions and medical license queriesWorking… Show more CRF Submissions: Deliver subject CRFs to support R&D Regulatory submissions and ad-hoc requests;Project Management oversight of TCS and liaise with Regulatory, Publishing & Submission Managers to ensure timely delivery and meet timelines for FDA submissionsFinancial Disclosures:Review reports TCS generates for FDA submissionState Sanctions: Implement and support a standardized program for addressing state sanctions and medical license queriesWorking with TCS in review of State Sanctions – weekly checks and periodic reportsConsultant to study teams across R&D & Vaccines to support Financial Disclosures, CRF Submissions and State Sanctions. Show less

Worked on Global Vaccine Clinical Trials in MMR/V and Neisseria Studies within the Clinical Operations department.Provide operational & project management support to ensure effective delivery of studies globally.TaskForce Lead - implemented and developed processes for TCS to provide quality review and checks of regulatory and site specific documents to align with GSK SOP's and ICH/GCP Guidelines. Champion of Document Collection System (DCS) to support the Central US… Show more Worked on Global Vaccine Clinical Trials in MMR/V and Neisseria Studies within the Clinical Operations department.Provide operational & project management support to ensure effective delivery of studies globally.TaskForce Lead - implemented and developed processes for TCS to provide quality review and checks of regulatory and site specific documents to align with GSK SOP's and ICH/GCP Guidelines. Champion of Document Collection System (DCS) to support the Central US team in Renaissance. Granted access, provided technical support and training as needed. Show less

Worked on ASCI - Vaccine Oncology Studies.Prioritized site initiations and submissions of regulatory documents to GSK Regulatory Affairs for approval.Review of Regulatory documents from study sites to ensure accuracy and quality in preparation for study start.

Worked on Adult and Pediatric Cardiovascular Studies.Site set up and tracking activities regulatory documents, contracts and grant payments); Regulatory document review for accuracy and liaised with study sites as applicable.Assures currency of required clinical trial documents within central files.Managed clinical grant tracking database for study and generated periodic reports on grant payment status as well as resolving payment inquiries from investigators as… Show more Worked on Adult and Pediatric Cardiovascular Studies.Site set up and tracking activities regulatory documents, contracts and grant payments); Regulatory document review for accuracy and liaised with study sites as applicable.Assures currency of required clinical trial documents within central files.Managed clinical grant tracking database for study and generated periodic reports on grant payment status as well as resolving payment inquiries from investigators as applicable.Site follow-up for resolution of data queries, outstanding adjudication documents, temporary and permanent drug discontinuation.Conducted file reviews & audits quarterly Show less