Ashley Lawrence
Associate Director, Site Contracts & Budgets
New Bern
Summary
Accomplished Associate Director at Moderna Therapeutics, renowned for strategic leadership and exceptional budget management skills. Spearheaded cross-functional teams, achieving significant operational cost reductions. Excelled in fostering key relationships and mentoring, ensuring project completion within budget and compliance. Demonstrated expertise in financial administration and operations management, consistently surpassing performance targets.
Overview
9
9
years of professional experience
1
1
Language
Work History
Associate Director, Clinical Budgets & Contracts
Moderna Therapeutics
12.2023 - Current
- Assisted senior leadership in managing all aspects of operations.
- Established internal controls to ensure budgets are within FMV and the actual investigator grant spend is within the governance approved budget
- Maintained compliance with industry regulations while adapting to best practices as needed.
- Reduced operational costs by identifying inefficiencies and implementing cost-saving measures in various departments.
- Assist Clinical Operations, CDO Business Analytics & Operations Management, and Finance in providing budget estimates for investigator grants for planned or future studies and reviewing and providing accurate forecasting for ongoing studies.
- Managed cross-functional teams for multiple large-scale projects, successfully completing each on time and within budget constraints.
- Established strong relationships with third-party vendors involved in outsourced activities related to site budget and contract management.
Senior Manager, Site Contracts and Budgets
Agios
09.2021 - 12.2023
- Established strong relationships with clients and stakeholders, ensuring long-term partnerships and repeat business.
- Implemented and developed operational standards, policies and procedures.
- Held monthly meetings to create business plans and workshops to drive successful business.
- Provided strong leadership to enhance team productivity and morale.
- Consistently met or exceeded annual performance targets set by senior leadership.
- Reduced costs, optimized resource allocation, and improved efficiency in managing projects.
- SME for Site Contracts and Investigator Grants
- Developed and managed a new global site contracting model, which includes a combination of in-house and outsourced contracting resources
- Responsible for creating innovative approaches to reduce cycle timelines and ensuring a
consistent contracting and FMV budgeting approach - Manage CRO teams requests and maintain key site contracting metrics
Senior Site Contract Leader
Parexel
04.2020 - 09.2021
- Led cross-functional teams to achieve company-wide goals, fostering a culture of collaboration and innovation.
- Acted as a functional leader on projects and developed Sponsor specific CSA and budget strategies
- Managed the global development, review, and negotiation of global FMV templates for multiple protocols
- Utilized the Grants Manager tool to develop Investigator Grant templates
- Developed defined "fallback", parameters, and ways of working for multiple Sponsors
- Presented in client meetings and internal meetings
- Manages the contracting process from global template development, to execution and through amendment stage
- Managed large global teams of local negotiators on multiple protocols
Contracts Counsel
Ora
10.2019 - 04.2020
- Managed a diverse caseload while maintaining excellent attention to detail and prioritizing tasks effectively under tight deadlines.
- Enhanced client satisfaction by providing comprehensive legal counsel and addressing individual concerns.
- Served as a trusted advisor for corporate executives on sensitive legal matters impacting company operations and strategy decisions.
- Worked as the SME for Clinical Trial Agreements
Investigator Site Contracts Manager
IQVIA
11.2015 - 10.2019
- Promoted from Investigator Analyst 2 to Investigator Site Contracts Manager
- Managed the build of Investigator Grants in the Grant Plan system
- Coordinated and managed the preparation, review, negotiation, and processing of Master Clinical Trial Agreements, Work Orders, Confidential Disclosure Agreements, and Clinical Trial Agreements for execution
- Provided legal, operational and financial contracting support while ensuring compliance with regulatory and local laws
- Managed Site budget requests against Sponsor directives
- Trained and mentored local negotiators across multiple protocols
- Supported the development and implementation of the oncology rapid start-up network
- Trained global RSU teams on rapid enrollment processes and managed RSU employees performing rapid enrollment tasks
Education
MBA -
Wake Forest
Remote 05.2001 -
J.D. -
Charlotte Law
Charlotte, NC 05.2001 -
Bachelor of Arts - Clinical Psychology
East Carolina University
Greenville, NC 05.2001 -
Skills
Team collaboration and leadership
Strategic leadership
Decision-making
Organizational development
Operations management
Coaching and mentoring
Budget development
Budget management
Financial administration
MS office
Key relationship management
Key relationship development
Accomplishments
- Achieved a significant reduction in Investigator Grant spending by implementing efficient budget development and negotiation processes.
- Supported the development of the Investigator Grant budgeting model which increased accuracy and reduced spending, incorporating innovative strategies and providing precise forecasts.
- Led the development of CRO guidance which reduced contract timelines and enhanced efficiency across therapeutic areas.
- Resolved complex contracting issues, ensuring compliance and operational success.
Timeline
Associate Director, Clinical Budgets & Contracts
Moderna Therapeutics
12.2023 - Current
Senior Manager, Site Contracts and Budgets
Agios
09.2021 - 12.2023
Senior Site Contract Leader
Parexel
04.2020 - 09.2021
Contracts Counsel
Ora
10.2019 - 04.2020
Investigator Site Contracts Manager
IQVIA
11.2015 - 10.2019
MBA -
Wake Forest
05.2001 -
J.D. -
Charlotte Law
05.2001 -
Bachelor of Arts - Clinical Psychology
East Carolina University
05.2001 -
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