Clinical Trial Research, project/program management, open to other ind

LESLIE RUHNO GRIMES, MS

Delta, PA ***** 267-***-**** *****************@*****.*** www.linkedin.com/in/lruhnogrimes

CLINICAL RESEARCH LEADER DRUG DEVELOPMENT EXPERT EQUITY ADVOCATE

Award-winning leader with over 20 years in CRO, Pharma, Biotech, Academia and SMO, offering well-rounded perspective on drug development. Skilled in alliance management, strategic planning, and leadership coaching and mentorship. Committed to improving access to healthcare and fostering diversity in clinical trials, bridging geographic, ethnic, socioeconomic, and social barriers. Recognized for delivering innovative solutions, building strong relationships, and driving business growth in global environments.

SKILLS

Leadership Strategic Planning Coaching Mentorship Process Improvement Change Management Risk Identification and Mitigation Clinical Trial Operational and Financial Oversight Client Engagement Healthcare Equality Curriculum Development Leadership Program Delivery Cross-Functional Collaboration Diversity Advocate KPI-driven Performance Evaluation Budgeting Wearables Vendor Management Contract and Budget Negotiation Expertise in Mobile Health Platforms and Innovative Clinical Solutions Microsoft Office Veeva IRT TMF integration Tempus Medidata ePRO/COA EMR

PROFESSIONAL EXPERIENCE

ICON PLC (formerly PRA HEALTH SCIENCES), Blue Bell, PA Jan 2018- Nov 2024

Executive Director, Project Delivery, Oncology, ICON BIOTECH, Remote (2022 – 2024)

As project delivery expert within global ICON matrix and leading team of 10 Senior Directors and Directors, developed strategy and risk identification and mitigation across 35 small- to mid-size biotech companies, leading client engagement and business growth within oncology biotech sector.

Led corporate improvement initiatives, including project financial review. Delivered 35% increase in on-time revenue recognition, quality oversight yielding >90% on-time CAPA actions and closure. Created partnership toolkit and implementation driving >50% decrease in voluntary turnover rates for staff working within partnership structures.

Drove innovative, cost-effective, and efficient strategy driving >50 trials within $450M book of business.

Led Executive Governance, ensuring alignment with client corporate goals and objectives, earning customer loyalty and resulting in >10 non-compete awards.

Performed quarterly Global Project Executive Risk Reviews for >50 studies with accountability to corporate financial and quality goals. Ensured rapid removal of barriers to delivery, maintaining >80% of programs with green rating.

Appointed Disability Awareness Network ERG Global Chair. Implemented quarterly global anchor events in 106 locations across 55 countries, created neurodiversity corporate policy, and introduced mandatory disability people leader training. Featured in corporate broadcasts for self-identification campaign, International Women’s Day, Wake Up to Culture, and International Day for Persons with Disabilities.

Created “Leadership in a Matrixed Organization” module as part of STRIDES Leadership Development Curriculum, leading live workshop quarterly for ~50 global project and biometrics management participants in advancing cohorts.

Senior Director of Project Delivery, Remote (2020 - 2022)

Ensured successful delivery of clinical trial projects, meeting timelines, budgets, and quality standards. Developed and implemented strategies to optimize project delivery and align with corporate objectives, anticipating and mitigating risks to maintain project efficiency and client satisfaction.

Recommended and implemented startup and recruitment projection tool (pSRM), holistic remote monitoring process, and financial oversight, resulting in streamlined processes, and increased visibility via roll-up reporting.

Built and maintained strong relationships with ~35 clients and key accounts, resulting in two comprehensive preferred provider selections.

Chaired operational oversight / executive steering committees for book of business, ensuring open lines of communication and rapid decision-making.

Analyzed portfolio metrics and oversaw partnership performance in line with partnership-aligned KPIs, resulting in >80% client satisfaction ratings via survey.

Served as Delivery Director Pathways Coach mentoring for four Project Directors in development to Delivery Director roles, each securing promotion to Delivery Director role within 12 months.

Appointed by SVP to COVID Corporate Executive Taskforce. Developed corporate strategy for business continuity. Revised / communicated process changes and served as operational subject matter expert for inquiries.

LESLIE RUHNO GRIMES 267-***-**** *****************@*****.*** Page 2

Director of Project Delivery, Remote (2018 – 2020)

Owned operational strategy and managed customer portfolio, ensuring delivery of projects and development of pipeline. Partnered with Business Unit Leader to define and develop strategic direction and best practices within Project Management. Led team of 12 Project Directors and Project Managers.

Measured project progress against KPIs, maintaining >80% client satisfaction ratings via survey responses.

Harmonized, communicated, and integrated global project management methodologies, aligning best practices for process integration, including finance, proposals, client engagement, and project oversight strategy.

Chaired operational oversight / executive steering committee for assigned customers ensuring delivery within KPIs.

Partnered with Technology Innovation to update mobile health platforms for broader use on global vaccine trials.

PREMIER RESEARCH, Morrisville, NC Mar 2017 – Dec 2017

Project Director, Remote

Managed customer relationships for clinical programs. Oversaw multiple clinical trials concurrently, leading and directing cross-functional team.

Led risk mitigation and issue resolution maintaining green overall project status via corporate KPIs.

Partnered with proposal development team, as Operations Lead reviewer, serving as final approver of budget and proposal package prior to delivery.

Proven winner in bid defense meetings with >75% award rate.

PAREXEL INTERNATIONAL, Durham, NC Aug 2013 – Mar 2017

Project Director, Remote

Led large and complex clinical trials and programs and project teams to achieve operational excellence, ensuring timeliness of project deliverables with proactive, solutions-based management approach.

Consulted with clients on PAREXEL services, utilizing early development expertise and solutions to drive successful and timely project execution, maintaining highest level on client satisfaction surveys (>90%).

Mentored Project Leaders in project oversight best practices, serving as a primary escalation point for risks/issues.

Partnered with proposal development teams to develop strategy, proposal and budget.

MEDSTAR HEALTH RESEARCH INSTITUTE, Washington, DC Dec 2010 – Aug 2013

SMO Administrative Director

Financial and operational oversight of general medicine research across 4-hospital network SMO (Baltimore / DC metro area).

Trained and mentored team of 25 direct reports while ensuring balanced budget in excess of $200M.

Conducted physician outreach operations resulting in >50% increase in Investigator Engagement across network.

PAREXEL EARLY PHASE CLINICAL UNIT, Baltimore, MD Jun 2007 – Dec 2010

Senior Project Manager

Concurrently managed portfolio of up to ten Phase I studies and served as primary contact for comprehensive clinical team. Allocated and monitored resources, ensuring efficiency and productivity. Consistently exceeded client expectations resulting in continual repeat business with >10 non-compete awards.

OSIRIS THERAPEUTICS, Baltimore, MD Mar 2005 – Jun 2007

Project Manager

Led selection and management of CRO and oversaw startup and ongoing conduct of CRO project team.

Managed multi-center and multi-protocol drug supplies ensuring quality data collection in line with study objectives.

Independently compiled, submitted, and obtained approval of application to Health Canada to initiate first sponsor-initiated stem cell clinical trial in Canada.

EDUCATION AND PROFESSIONAL DEVELOPMENT

MS Biotechnology, The Johns Hopkins University, Baltimore, MD

BA Biology, University of North Carolina, Wilmington, Wilmington, NC

ICON Senior Leadership Accelerated Development Program Graduate, 2023

INDUSTRY APPOINTMENTS AND AWARDS

PharmaTimes Clinical Researcher of the Year Americas Steering Committee and Judges Panel, 2023 - 2024

PharmaTimes Clinical Researcher of the Year Americas, Strategic Team, GOLD, 2021; Company Team, GOLD, 2020

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