Kathryn Golemboski
Summary
Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.
Overview
9
9
years of professional experience
Work History
Manager, Site Budgets & Contracts Lead
Regeneron Pharmaceuticals Inc
01.2023 - Current
- Provide subject matter expertise for assigned therapeutic areas
- Accountable for ensuring that performance and efficiency standards are met for assignments
- Provide ongoing guidance to peers on site budgeting
- Utilize a fair market value tool and other relevant data to develop total investigator grants, per subject cost estimates, and budget scenarios
- Utilize the per subject cost output along with the protocol design, historical information, and operational approach to determine the overall investigator grant cost
- Develop and present budget scenarios to study teams and key stakeholders for related meetings
- Develop country and site level facing documents for assigned studies
- Engage with relevant stakeholders from early planning throughout the end-to-end budgeting lifecycle
- Help develop and enhance site budgeting processes
- Handle site budgeting related escalations effectively and efficiently and conduct issue resolution of moderate to high complexity
- Effectively and efficiently prioritize assignments
- Stay abreast of changes in industry standards and help identify new best practices to contribute to continuous improvement
- Help train others on site budgeting and industry practices
- Manage changes to study scope, ensuring timely budget amendment and implementation
- Single point of contact for non-standard budget line items which require internal approval
Global Template Development Specialist
IQVIA Biotech
02.2021 - 12.2022
- Developed country level Site Contracts, Budgets, Payment Schedules and ancillary/supplemental agreement templates with sponsors
- Developed country level contract fall back language parameters and budget negotiation parameters with sponsors for assigned studies
- Developed country level process documents for assigned studies
- Developed and update a Study Information sheet/tool for each study
- Attended Internal and Sponsor calls which relate to study template development, as needed
- Interacted with other departments regarding the study start-up process
- Worked with in-house Legal to help facilitate and finalize Global Site Contracts templates, as needed
- Coordinated study transition of templates, parameters, process documents and other study/protocol specific information to the assigned Site Contract Associate(s)
- Coordinated and updated management team with template status updates
- Attended Study Transition Meetings, Client Alignment Meetings and Client Kick-Off meetings, as requested.
- Provided back-up support for Investigator Grant Estimate development and QC review
- Performed other duties as assigned
- Created and updated Investigator Grants using the GrantPlan costing tool.
- Tasks included: Preparing protocol specific, initial draft of Investigator Grants for patient and site cost forecasting for Sponsor Proposals/Budgets to be utilized in Request for Proposals, maintaining, and updating Investigator Grants tracker, working directly with other internal departments, training new team members, managing escalations
Budget Analyst II
ICON PLC
01.2020 - 02.2021
- Assisted Amgen as a Clinical Pricing Associate
- Compliance and legal checks; debarment/exclusions, due diligence, country specific checks, fair market value, conflict of interest check for Data Monitoring Committees
- Managed and processed payments as well as generated purchase and change orders
- Reviewed invoices to ensure consistency with contracts and compliance guidelines
- Maintained payment records and provide assistance with payment status, resolving issues as applicable
- Met specific compliance checks e.g Hospitality requirements
- Maintained consultancy related documentation in the appropriate systems
- Supported resolution of consultancy arrangement issues
- Escalated engagement-related issues to Global Clinical Project Manager, Therapeutic Area Head, Legal, and Healthcare Compliance as appropriate
- Processed arrangement requests and generated contracts
- Ensured compliance and legal requirements were met for Healthcare Professional contracts per country specific requirements
- Interpreted country compliance requirements and recognized when to escalate to country compliance lead
- Liaison between Responsible Amgen Employee and Site Contract/Budget Analyst during contract negotiations
- Stored and archived consultancy records in the appropriate systems.
Associate Investigator Grant Analyst
PPD
06.2018 - 12.2019
- Performed and coordinated all activities required to develop global investigator grant budget grids ensuring compliance with local legislation and practice
- Drafted applicable payment terms and conditions templates for investigator grant budget grids ensuring compliance with local legislation and practice
- Acted as single point of contact and escalation with internal/external clients for investigator budget development, process and negotiation parameters
- Facilitated effective budget negotiation in collaboration with key stakeholders
- Adapted investigator grant budget grids and payment terms to client and investigational site requirements in collaboration with key stakeholders to include internal/external clients' project team(s) and legal team(s)
- Served as single point of contact and escalation with internal/external client for budgetary issues and negotiations throughout the lifecycle of a study
- Assumed responsibility for any ongoing budget amendments
- Performed Quality Control inspection and prepared Investigator Grant Calculator Tool for Contracts and Proposals to ensure that accurate information was provided for bidding for new study opportunities
Project Assistant II
PPD
04.2018 - 06.2018
- Oversaw completion of Confidentiality Disclosure Agreements and site feasibility assessments from investigative sites, documenting in real time all communication attempts and follow up associated with site contact and survey responses
- Responsible for review of Electronic Medical Records/ Electronic Health Records checklists, tracking in CTMS, and filing in the Global Investigator Document Repository
- Obtained goBalto accounts for designated investigative site staff in advance of pre-study visits.
Project Assistant
PPD
11.2016 - 03.2018
- Responsible for providing administrative support to the North America Pre-Study Visit (PSV) Country Team in Site Intelligence & Activation (SIA)
- Provided resourcing requirement predictions to the SIA Country Manager and work to effectively resource and utilize personnel when scheduling and assigning PSVs
- Responsible for assisting the CRA team reach the monthly target for PSVs scheduled and completed
- Responsible for communicating with sites to schedule PSVs, discuss feasibility concerns and/or questions and setting a positive first impression of PPD
- Responsible for scheduling on-site and remote PSVs, in accordance with contracted study timelines, for twenty SIA CRAs in addition to any Clinical Management CRAs assisting the core team
- Coordinated Accompanied Field Visits for observation and sign-off
- Tracked important study data in the company database and PSV scheduling tracker
- Maintained SIA CRA travel calendar
- Trained and mentored new Project Assistants in the PSV Scheduler role.
Legal Assistant
Woody White Attorneys at Law
05.2015 - 11.2016
- Responsible for providing administrative support to the partners at the firm
- Performed paralegal clerical duties, while managing multiple responsibilities
- Prepared and finalized legal documents daily, as well as prepared invoices
- Familiarity with contract/agreement terms and jargon
- Thrived in a challenging environment that is deadline driven
- Coordinated schedules, conference calls, and documents with strong attention to detail to meet the legal needs of clients.
Education
Bachelor of Arts - Communication Studies
University of North Carolina-Wilmington
Wilmington, North Carolina05.2015
Skills
- Team Leadership
- Time Management
- Verbal and written communication
- Complex Problem-Solving
- Staff Training and Development
- Cross-Functional Teamwork
- Computer Skills
- Scheduling and Coordinating
Computer Experience
Microsoft Office, Microsoft Outlook, Adobe Professional, GrantPlan, Medidata, Veeva Vault, CTMS, ETMF, Qlik Sense
Additional Information
GSK-PPD Strategic Partnership Performance Excellence Award October 2019
Timeline
Manager, Site Budgets & Contracts Lead
Regeneron Pharmaceuticals Inc
01.2023 - Current
Global Template Development Specialist
IQVIA Biotech
02.2021 - 12.2022
Budget Analyst II
ICON PLC
01.2020 - 02.2021
Associate Investigator Grant Analyst
PPD
06.2018 - 12.2019
Project Assistant II
PPD
04.2018 - 06.2018
Project Assistant
PPD
11.2016 - 03.2018
Legal Assistant
Woody White Attorneys at Law
05.2015 - 11.2016
Bachelor of Arts - Communication Studies
University of North Carolina-Wilmington