Associate Director, Clinical Operations – Study Startup

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

📋 Description

• Responsible for collaborating with the Clinical Operations team to provide high-quality, client-focused, and profitable clinical startup services.

• Proactively manages projects during the startup phase and serves as a subject matter expert for clients regarding startup processes.

• Establish and nurture strong client relationships to foster mutually beneficial long-term partnerships.

• Lead and supervise clinical study startup teams and oversee project startup activities.

• Collaborate with Clinical Operations Leads, Project Managers, sponsors, and cross-functional teams to create and implement effective startup strategies.

• Actively enhance study startup performance throughout site identification, feasibility assessment, site selection, ethics/regulatory submissions, site activation, contract and budget negotiations, and essential document collection.

• Ensure the quality and completeness of startup deliverables by reviewing regulatory submissions, essential documents, startup trackers, and study records.

• Monitor project startup timelines, KPIs, cycle times, and quality metrics to ensure adherence to objectives.

• Provide leadership, mentoring, and line management for Clinical Trial Assistants and Site Contracts/Budgets teams.

• Conduct business analysis and benchmarking within startup services to identify opportunities for ongoing improvement.

⛳️ Requirements

• A minimum of a bachelor’s or master’s degree in science, health studies, research fields, or a related discipline.

• At least 14 years of experience in clinical research.

• Experience in business and operational management.

• Comprehensive business operations experience in a clinical research environment, preferably within the Clinical Research Organization sector.

• Strong industry reputation with a broad network of contacts.

• Demonstrated experience in leading an organization towards optimal performance and contributions.

• Exceptional people management abilities.

• Outstanding written communication and presentation skills.

• Travel requirements: this position may involve 20% to 50% business travel.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Life & AD&D insurance.

• Short- and long-term disability coverage.

• Tuition reimbursement.

• Fitness reimbursement.

• Employee assistance program (EAP).

• 401(k) retirement plan.

• Generous paid time off and sick leave.

• Performance-based bonus.