Director, Clinical Trial Strategy & Optimization

Sarah Cannon Research Institute•Usa, TN

6d•Remote

About The Position

The Director, Clinical Trial Strategy & Optimization is responsible for leading efforts to streamline and enhance clinical trial processes to accelerate study delivery while improving quality, consistency, and operational effectiveness. This role drives critical strategic initiatives across the clinical trial lifecycle, identifies opportunities for process improvement, and partners closely with cross-functional teams to implement scalable solutions that support business goals and high-quality trial execution.

Requirements

Bachelor's Degree required
At least 5 years of experience in clinical trials is required
Knowledge of scientific, medical, and regulatory terms
Knowledge of ICH Guidelines, GCP, and CFR Title 21
Clinical research process knowledge with an understanding of medical terminology
Sophisticated problem-solving skills
Highly organized
Flexible and adaptable
Strong communication skills; persuasive, encouraging, motivating, and inspiring; the ability to listen and understand; the ability to communicate the complex in simple terms
Ability to establish relationships - develop strategic relationships within and outside of direct organization
Facilitation and communication skills - able to drive plans, decisions, and resolve issues through facilitation of groups or individuals
Process improvement skills and techniques
Change management skills and techniques
Excellent active listening skills
Experience working in a matrix environment and with virtual team members / stakeholders
Ability to thrive in team environments of considerable change
Ability to define vision and lead through change
Ability to partner with individuals at all levels of management and across organization boundaries
Ability to work across many teams to identify business opportunities and drive to consensus

Responsibilities

Identify opportunities to optimize clinical trial processes across the study lifecycle and drive process changes that improve speed, quality, consistency, and operational efficiency.
Lead cross-functional teams in the design, implementation, and sustainment of process improvements that support high-quality and timely clinical trial delivery.
Ensure site perspectives are represented in process redesign efforts and partner with site stakeholders to bring them along through change planning, communication, training, and adoption.
Assess current-state workflows, identify root causes of inefficiencies, and prioritize improvement initiatives based on business impact, feasibility, and alignment with strategic goals.
Develop and monitor key performance indicators, dashboards, and reporting to track process improvement outcomes, risks, and opportunities across clinical trial operations.
Report progress, insights, and recommendations to executive leadership, providing clear updates on strategic initiatives, implementation status, and measurable impact.
Establish governance, documentation, and standard work to support consistent execution of updated processes and promote a culture of continuous improvement.
Build strong partnerships across clinical, operational, quality, technology, and site teams to align stakeholders, remove barriers, and deliver changes to process.
Collaborate with sites, sponsors, contract research organizations, and vendors as needed to support process alignment, operational readiness, and successful implementation of change.
Ensure process improvements are implemented in alignment with quality standards, regulatory requirements, and organizational priorities while maintaining focus on sustainable execution.