This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Clinical Operations (Contract) based in United States.
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.
Responsibilities
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.
Demonstrated ability to lead and influence cross-functional teams without direct authority.
Strong communication, collaboration, and interpersonal skills, with the ability to work effectively across technical and non-technical functions.
Highly organized and capable of managing multiple priorities in a fast-paced clinical development environment.
Creative, adaptable, and solutions-oriented approach to challenges involving timelines, quality, resources, and budgets.
Proactive problem-solving mindset with the ability to anticipate needs, take initiative, and implement practical solutions.
Strong attention to detail and commitment to maintaining quality, compliance, and inspection readiness.
Conditions
Hourly compensation range of $75–$110 USD, depending on qualifications, skills, relevant experience, and job knowledge.
Remote work opportunity for candidates based in the United States.
Contract-to-hire structure with potential to transition to a permanent position.
Occasional travel associated with the role.
Access to a comprehensive benefits package through the third-party employer of record.
Eligible contractors may enroll in medical coverage, including PPO and EPO options, after 30 days.
Dental and vision coverage available to eligible contractors after 30 days.
Potential access to a 401(k), wellness programs, and additional discounts.
Opportunity to contribute to clinical development programs focused on innovative treatments for neurological and sleep-related conditions.
Collaborative, cross-functional environment with exposure to clinical, regulatory, scientific, and operational teams.