Director, Site Management Operations, Clinical Trials (Remote)

Walgreens; United States; Remote; USD 90,000 - 160,000; Full time

Job summary

An established industry player is seeking a Director for their Site Management Organization to lead the implementation of clinical trial sites across a vast community pharmacy network. This pivotal role involves driving operational excellence, ensuring regulatory compliance, and fostering innovation to enhance clinical trial activities. The ideal candidate will possess a strong background in clinical trial operations and site management, with a proven ability to lead teams and optimize performance. Join a forward-thinking organization where your leadership will contribute to shaping the future of clinical trials and improving patient outcomes. This is an exciting opportunity to make a significant impact in a dynamic environment.

Qualifications

• 8+ years in clinical trial operations and site management required.
• Strong leadership and financial acumen essential for success.
• Experience in regulatory compliance and strategic planning.

Responsibilities

• Manage clinical trial site operations ensuring compliance and efficiency.
• Foster collaboration and continuous improvement across all sites.
• Lead financial planning and monitor performance metrics.

Skills

Clinical trial operations

Site management

Team leadership

Financial modeling

Regulatory compliance

Project management

Analytical skills

Problem-solving

Strategic thinking

Relationship building

Education

Bachelor's degree

High School/GED

Tools

eSource

eISF

CTMS

Job description

Job Summary:

The Director, Site Management Organization (SMO) will be responsible for the enterprise wide implementation and management of clinical trial sites across our community pharmacy network. This member of the leadership team is responsible for driving operational excellence, regulatory compliance, and business growth through strategic partnerships, innovative practices, and integration of clinical trial activities. The Director, SMO is responsible for fostering a culture of high performance and executing programs that ensure our SMO remains at the forefront of the industry.

Job Responsibility:

• Manage clinical trial site operations nation-wide, ensuring adherence to applicable regulations, study protocols, timelines, and contracts.
• Optimize performance metrics and operational efficiencies across all sites.
• Foster a culture of collaboration, continuous improvement, and high performance.
• Oversee the operational implementation of Good Clinical Practice (GCP) and FDA regulations across all clinical trial sites, ensuring alignment with industry standards and best practices.
• Integrate Quality by Design (QbD) principles into the operational workflows to enhance site performance and trial outcomes.
• Develop and manage systems and processes that ensure compliance with regulatory requirements without compromising operational efficiency.
• Collaborate with site management teams to incorporate risk-based quality control checks into daily operations, proactively identifying and addressing potential issues.
• Ensure that all clinical trial activities are conducted with a focus on operational excellence, maintaining a balance between quality and efficiency.
• Lead advanced financial planning, budgeting, and cost management strategies, related to the SMO.
• Monitor financial performance and implement cost-saving initiatives.
• Develop strategies for optimal resource utilization and allocation across the business.
• Collaborate with internal stakeholders (e.g., pharmacy operations, marketing, and IT) to ensure seamless integration of clinical trial activities within the broader organization.
• Lead innovation initiatives, identifying and implementing cutting-edge practices and technologies.
• Contribute to market analyses and competitive benchmarking to maintain industry leadership.
• Oversee the integration of advanced technologies (e.g., AI, machine learning) into clinical trial processes.
• Develop and lead leadership training and mentorship programs for clinical trial site staff.
• Function as business-owner for site management technologies (e.g., eSource, eISF, CTMS), tracking performance of technology vendors and resolving any performance issues.
• Contribute to the development and management of strategic partnerships with sponsors, CROs, healthcare providers, and other key stakeholders.
• Support the commercial strategy, identifying new business opportunities and revenue streams.
• Engage with external stakeholders, including regulatory bodies, industry groups, and patient advocacy organizations.
• Represent the business at industry conferences, meetings, and other forums to promote our clinical trial capabilities.
• Stay abreast of industry trends, emerging technologies, and regulatory changes, providing strategic recommendations to enhance the capabilities and competitive advantage of the business.

Minimum Requirements:

• Bachelor’s degree and at least 8 years Clinical trial operations, site management, and team leadership OR High School/GED and at least 11 years Clinical trial operations, site management, and team leadership.
• Experience in communicating, both internally and externally, with individuals at the Executive level.
• Experience in scaling clinical trial operations.
• Experience in financial modeling.
• Experience in regulatory and compliance.
• Experience in leading and managing a large team of clinical operations professionals, preferably within an SMO or multi-site organization.
• Extensive experience in overseeing the operational aspects of clinical trial site management, with a strong understanding of regulatory compliance.
• Strong business acumen and strategic mindset, with the ability to develop and execute plans that drive growth, operational excellence, and customer satisfaction.
• Experience in thinking strategically and execute operational plans effectively.
• Strong financial acumen and experience managing budgets.
• Demonstrated experience in building and maintaining relationships with key stakeholders, including investigators, sponsors, and CROs.
• Experience in project management skills with a proven ability to manage multiple complex projects simultaneously, meet deadlines, and deliver high-quality results.
• Experience in influencing and collaborating effectively with internal teams and external partners.
• Experience in analytical and problem-solving, with a data-driven approach to decision-making and a commitment to continuous improvement.
• Demonstrated commitment to quality, compliance, and patient safety in all aspects of clinical operations.
• At least 5 years of experience contributing to financial decisions in the workplace.
• At least 5 years of direct leadership, indirect leadership and/or cross functional team leadership.
• Willing to travel up to/at least (25%) of the time for business purposes (within state and out of state).