Associate Director, Clinical Operations (Contract)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Associate Director, Clinical Operations (Contract) based in United States. As an Associate Director, Clinical Operations, you will provide strategic and operational leadership across clinical trials throughout the development lifecycle. You will oversee study execution from start-up through close-out, ensuring milestones, budgets, quality standards, and regulatory requirements are met. The role combines hands-on clinical operations expertise with cross-functional leadership and vendor management. You will work closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and external partners. Your oversight will help identify risks early, maintain study momentum, and support high-quality trial execution across domestic and international programs. The position offers the opportunity to contribute to the development of innovative medicines for neurological and sleep-related conditions. This is a remote, contract-to-hire opportunity with occasional travel and the potential to transition into a permanent role. Accountabilities: - Lead and oversee end-to-end clinical trial operations from study start-up through close-out across assigned development programs. - Develop and execute operational plans, timelines, milestones, and performance metrics to ensure successful study delivery. - Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and other cross-functional teams to coordinate efficient trial execution. - Contribute to the development, review, and implementation of key study documents, including protocols, informed consent forms, monitoring plans, EDC specifications, and statistical analysis plans. - Develop, manage, and monitor clinical trial budgets to ensure studies remain within approved financial parameters. - Provide regular updates to senior leadership and key stakeholders regarding study progress, milestones, risks, issues, and operational performance. - Proactively identify operational risks and develop mitigation strategies to protect timelines, quality, compliance, and budget.

- Support the execution and management of contracts, clinical trial agreements, budgets, and other study-related documentation. - Contribute to regulatory strategy and support submissions and interactions with regulatory authorities, Institutional Review Boards, and Ethics Committees. - Manage CROs, vendors, and external partners, ensuring performance meets established expectations and quality standards. - Ensure clinical operations activities comply with applicable company SOPs, GCP, ICH guidelines, and regulatory requirements. - Support inspection readiness activities and ensure appropriate documentation and processes are maintained throughout the clinical development lifecycle. Requirements: - Bachelor’s degree in a scientific field required; an advanced degree is preferred. - 8+ years of experience within pharmaceutical, biotechnology, or CRO environments. - Proven experience managing clinical trials across multiple phases, including Phase 1–3 studies and domestic and international programs. - Experience supporting global clinical trials is preferred. - Strong working knowledge of clinical trial operations, global regulatory requirements, ICH guidelines, and GCP. - Solid understanding of clinical development project management, including timelines, resources, budgets, risks, and operational dependencies. - Demonstrated experience overseeing CROs, vendors, and other external partners. - Experience using clinical trial management systems. - Prior experience supporting FDA regulatory submissions is a plus. - Experience in CNS and/or sleep disorders is preferred. - PMP certification or formal project management training is a plus.