Kathleen Schultz Email and Phone Number

• Responsible for operational execution of Late Development Book of Work across various therapeutic areas and study types (e.g., NIR, ISR, Strategic Collaboration, Pre-Approval Access and Phase IV). • Primary point of contact for both internal and external stakeholders.• Manages protocols within a complex matrix environment for successful and timely operational execution of research from startup to closeout.• Implement project management concepts… Show more • Responsible for operational execution of Late Development Book of Work across various therapeutic areas and study types (e.g., NIR, ISR, Strategic Collaboration, Pre-Approval Access and Phase IV). • Primary point of contact for both internal and external stakeholders.• Manages protocols within a complex matrix environment for successful and timely operational execution of research from startup to closeout.• Implement project management concepts to support issue resolution, risks mitigation, timeline adherence and budget preservation.• Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams.• Subject Matter Expert in Veeva CTMS Externally Sponsored Research- provided all training on ESR module for all Late development Trial Managers/GTM’s during rollout of Veeva CTMS, assisting in UAT testing for new releases. • Support Pre-approval Access (PAA) team with patient access requests providing consultation on issues and recommendations for improvement. Ensure overall Regulatory compliance while managing deliverables through collaboration with internal and external stakeholders. • Consistently maintain high data quality in CTMS. • Ability to work independently, while collaborating and escalating issues as necessary.• Provided end-to-end management of Non-Regulatory Data Generation (NRDG) clinical research for Investigator Sponsored Research studies in the Cardiovascular Area.• Managed protocols within a complex matrix environment for successful and timely operational execution of clinical research from start to end.• Focused on project management concepts to support management of issues, risks, timelines and budget.• Monitored trial progress.• Developed protocol-level documents and plans and training.• Identified issues and risks, escalating appropriately.• Monitored study budget. Show less

• Provided end-to-end management of Non-Regulatory Data Generation (NRDG) clinical research for Investigator Sponsored Research studies in the Cardiovascular Area.• Managed protocols within a complex matrix environment for successful and timely operational execution of clinical research from start to end.• Demonstrated flexibility and managed ISR studies in the Cardiovascular Area.• Focused on project management concepts to support management of issues… Show more • Provided end-to-end management of Non-Regulatory Data Generation (NRDG) clinical research for Investigator Sponsored Research studies in the Cardiovascular Area.• Managed protocols within a complex matrix environment for successful and timely operational execution of clinical research from start to end.• Demonstrated flexibility and managed ISR studies in the Cardiovascular Area.• Focused on project management concepts to support management of issues, risks, timelines and budget.• Leveraged interpersonal and influencing skills to foster partnerships across multidisciplinary teams.• Monitored trial progress.• Addressed and managed obstacles• Developed protocol-level documents and plans and training.• Identified issues and risks, escalating appropriately.• Monitored study budget.• Managed and complied with various quality and compliance systems.• Ensured successful clinical studies by providing operational support for the day-to-day execution of clinical trials.• Facilitated weekly status meetings; Provide Issue tracking and resolution and escalation as required across all projects. • Supported Medical Directors (for WW and US HEOR) ensuring their BOW is completed in a timely manner.• Created status reports and provide ongoing updates to show progress. • Budget creation, tracking and reconciliation for assigned projects.• Manage on-going relationship by reviewing vendor reports, budgets, and metrics; act as liaison between vendors and BMS personnel.• Provided HEOR and ISR process trainings to new team members. • Managed studies for US HEOR/WW HEOR – from study set up to study close out. • Managed monthly ISR Priority dashboard content for Cardiovascular area ensuring clean data.• Ensured study invoices are processed in a timely manner.• Facilitated CDA execution for new studies. Show less

• Ensured successful clinical studies by providing operational support for the day-to-day execution of clinical trials.• Assisted in meeting planning for clinical trial meetings (e.g., Investigator Meetings) by arranging logistics, contracting and payments.• Facilitated weekly status meetings; Provide Issue tracking and resolution and escalation as required across all projects. • Supported Medical Directors (for WW and US HEOR) ensuring their… Show more • Ensured successful clinical studies by providing operational support for the day-to-day execution of clinical trials.• Assisted in meeting planning for clinical trial meetings (e.g., Investigator Meetings) by arranging logistics, contracting and payments.• Facilitated weekly status meetings; Provide Issue tracking and resolution and escalation as required across all projects. • Supported Medical Directors (for WW and US HEOR) ensuring their BOW is completed in a timely manner.• Created status reports and provide ongoing updates to show progress. • Budget creation, tracking and reconciliation for assigned projects.• Manage on-going relationship by reviewing vendor reports, budgets, and metrics; act as liaison between vendors and BMS personnel.• Provided HEOR and ISR process trainings to new team members. • Managed studies for US HEOR/WW HEOR – from study set up to study close out. • Managed monthly ISR Priority dashboard content for Cardiovascular area ensuring clean data.• Ensured study invoices are processed in a timely manner.• Facilitated CDA execution for new studies.• Special Projects as they arise- i.e., working on team to pilot use of My Trials for distribution of Investigator Brochures and Suspected Unexpected Serious Adverse Reaction (Susars), NRDG portal development/ISR, Audits. Show less

• Managed contract execution CROs, Central and Specialty Labs • Provided guidance to team members with questions and issues that needed resolution before escalation to manager.• Proactively identified issues and helped resolve them before they became a rate limiting. • Suggested ideas for improvement that help simplify the processes within the group. • Built relationships with vendors regarding managing their invoices and insuring timely payment. • Assisting in… Show more • Managed contract execution CROs, Central and Specialty Labs • Provided guidance to team members with questions and issues that needed resolution before escalation to manager.• Proactively identified issues and helped resolve them before they became a rate limiting. • Suggested ideas for improvement that help simplify the processes within the group. • Built relationships with vendors regarding managing their invoices and insuring timely payment. • Assisting in FDA audits – gathered contract data for studies related to the audit.• Became proficient in new systems rolled out by BMS such as Onyx and Eclipse.• Set up funds in Eclipse for vendor payments.• Routed Vendor Master Service Agreements (MSA) and other contracts in Onyx for approval. • Reviewed invoices to ensure the activities / charges billed were included in the approved budget for the contract.• Payment of invoices in SAP. Show less

• Processed invoices related to Technology contracts (including Fixed Price and T&M Capped).• Maintained accurate Excel timesheets to expedite research into past activity.• Established IDs for new consultants within BEN (Business Engine Network- web based application used for managing initiatives and projects). Requesting Maintenance for consultant changes. • Produced Headcount Report for over 2000 employees on a monthly basis, updating historical Headcount… Show more • Processed invoices related to Technology contracts (including Fixed Price and T&M Capped).• Maintained accurate Excel timesheets to expedite research into past activity.• Established IDs for new consultants within BEN (Business Engine Network- web based application used for managing initiatives and projects). Requesting Maintenance for consultant changes. • Produced Headcount Report for over 2000 employees on a monthly basis, updating historical Headcount Reports utilizing Excel spreadsheets, V Lookups/Pivot tables.• Entered new requisitions into Access Database, accruals schedules and payment schedules to ensure smooth month end close.• Worked closely with vendors and technology managers to resolve issues regarding invoices and special projects- example: Analysis of 2006 vendor invoices to identify discounts earned but not taken resulting in $100K savings to the firm.• Resolved time posting issues in Ben by working with Ben Support team and Technology Managers which substantially increased the accuracy of Monthly RAQs accruals. Show less

• Performed due diligence on invoices for adherence to contract terms and prepared credit memo’s where appropriate.• Worked with vendors and internal clients to facilitate the processing of invoices.• Investigated problem invoices following through to resolution, often having to push back when invoices fell outside of contract terms or company policy.