Associate Director, Clinical Trial Start-Up

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Lead or supervise the formulation and implementation of study-level start-up strategies, activation plans for countries/sites, and risk mitigation tactics through SSU roles and/or CRO.

• Create projections for site activation and contribute to the development of study timelines through a data-driven evaluation of country requirements, historical timelines, predictive analytics, and emerging technologies.

• Act as a Subject Matter Expert in global study, country, and site start-up pathways.

• Collaborate cross-functionally to provide start-up insights and strategies that inform country and site selection, timelines, and activation approaches.

• Monitor and evaluate SSU performance metrics, identify trends and issues, and address and communicate potential risks.

• Utilize historical and predictive data, real-world evidence, and innovative technologies to enhance start-up strategies and activation processes.

• Supervise SSU team members, offering guidance, training, and performance feedback.

• Oversee CROs/vendors carrying out start-up activities, including monitoring performance against KPIs and timelines.

• Lead or assist in initiatives aimed at improving start-up methodology, quality, tools, and process efficiency.

• Ensure audit and inspection readiness by maintaining accurate and complete documentation of start-up activities and regulatory submissions.

• Engage in the development and refinement of global SSU policies, SOPs, and training programs.

• Represent SSU in industry discussions, cross-industry collaborations, and internal governance meetings.

⛳️ Requirements

• Recognized as a subject matter expert in clinical site start-up with a solid operational understanding of global regulatory requirements, IRB/EC processes, and site activation pathways.

• Proven capability to drive cross-functional decision-making through data-driven insights.

• Demonstrated success in supporting or leading global clinical start-up strategies in both in-house and outsourced models, particularly in oversight of CROs or vendors.

• Experience in leveraging digital technologies to inform study planning and optimize start-up processes.

• Ability to analyze complex issues and apply strategic thinking to identify risks and resolve operational challenges across cross-functional environments.

• Strong leadership, collaboration, and communication skills, with the ability to influence cross-functional teams and external partners.

• Proficient with CTMS, document management systems, and SSU technology platforms (e.g., Veeva Vault).

• Preferred experience in the assessment or utilization of AI in the SSU domain.

• Experience in contributing to inspection readiness and continuous process improvement initiatives.

• Willingness to travel 10% to 20%, both domestically and internationally.

• Bachelor’s degree in life sciences or a related field is required.

• 8-10 years of experience in clinical research, with a minimum of 5 years focused on clinical trial start-up or site activation.

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation.

• Discretionary equity grants.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k retirement savings plan.

• Flexible paid vacation.

• Willingness to travel 10% to 20%, both domestically and internationally.