Vice President Clinical Operations

Responsibilities:

The VP of Clinical Operations oversees all aspects of clinical trial execution, including staff management, site operations, and compliance, to ensure studies run efficiently and meet regulatory standards. This role also drives strategic growth by scaling operations, integrating acquisitions, and optimizing processes to support a national site network.

• Develop, review, and ensure compliance with SOPs, updating them to align with regulatory changes and industry best practices.
• Oversee clinical operations staff, ensuring alignment with company goals, setting performance metrics, conducting evaluations, and providing coaching.
• Plan and lead regular clinical operations meetings, providing updates on project progress, addressing challenges, and aligning team efforts.
• Oversee issue escalation processes to ensure timely resolution, serving as a key decision-maker for complex or critical issues.
• Oversee preparation and response to regulatory audits and inspections, ensuring adherence to GCP, FDA, and other applicable guidelines.
• Lead site selection visits and evaluations for new trials, providing support and guidance to site managers to optimize site performance.
• Review and revise eligibility email drafts for a favorable outcome and to ensure protocol compliance is maintained.
• Create general and site-specific NTFs to clarify processes, and address sponsor/CRO concerns.
• Oversee and advise on early terminations and investigational product (IP) dose modifications.
• Ensure timely and accurate SAE reporting across all clinical sites, monitoring trends and implementing preventive measures for patient safety.
• Manage the setup and operationalization of new clinical trial sites, ensuring readiness for trial execution, including staffing, training, and infrastructure.
• Oversee the integration of newly acquired sites or companies into the clinical operations network, aligning processes, systems, and teams with company standards.
• Develop and implement strategies for scaling clinical operations to support a national network of trial sites, driving operational efficiencies and standardization across all locations.
• Act as a liaison between internal teams (e.g., regulatory, quality assurance, and business development) and external stakeholders, fostering strong partnerships with sponsors, CROs, and site networks.
• Identify opportunities for process enhancements to improve trial efficiency and quality, leveraging technology and data analytics to optimize clinical operations.
• Foster a culture of accountability, collaboration, and professional growth.

Skills:

• Excellent analytical and organizational and time management skills
• Ability to lead cross functional study teams in a dynamic, evolving organization
• Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions

Must be able to interface and collaborate effectively with executives, PhD researchers, medical professionals, statisticians, project managers, software developers, and colleagues.

Position Details:

This is a full-time, hybrid position. Adams Clinical is a business with standard operating hours between 8am and 6pm M-F. There is no on-call schedule and generally no weekend work. Applicants should anticipate a 40-hour work week, with schedule flexibility possible.

Minimum Requirements:

• Experience: Minimum of 5 years in high-level operations or management position
• Project Management: Proven expertise in project management, workflow development, and managing clinical Key Performance Indicators (KPIs).

In-depth understanding and experience across clinical operations with a track record of success