Associate Director Clinical Operations (San Francisco, CA)Summary
We are looking for an Associate Director of Clinical Operations to lead the setup and execution of clinical studies, as well as oversee vendor management and sponsor oversight activities.
Reporting to the Head of Clinical Operations and COO, this role involves project planning, budget management, and operational execution to ensure compliance with good clinical practices and regulatory guidelines.
The ideal candidate will bring technical expertise, exceptional communication skills, and a collaborative mindset to excel in a fast-paced and innovative environment.
ResponsibilitiesLead the overall operation of clinical studies, including project planning, budget management, and CRO oversight.
Develop and execute clinical operational plans, incorporating study and scientific objectives.
Oversee the creation of study-related documents and provide direction to CROs and clinical sites to ensure adherence to protocols.
Ensure compliance with good clinical practices (GCP) and regulatory guidelines.
Manage and document the escalation and resolution of issues while maintaining high-quality standards.
Recommend and implement innovative processes to improve clinical trial management.
Oversee study budgets and closely monitor CRO and vendor activities to ensure alignment with statements of work and budgets.
Manage and document vendor oversight, maintaining inspection readiness throughout the study lifecycle.
Oversee in-house central laboratory activities required for study execution.
Support quality documentation and regulatory inspection preparation as needed.
Prepare and present regular project updates to leadership and internal/external stakeholders.
Foster a collaborative, quality-driven culture with colleagues, consultants, and CRO partners.
Support strategic clinical operations initiatives, including study design, protocol development, and operational infrastructure development.
RequirementsBachelor's or advanced degree in life sciences, healthcare, or a related field.
8+ years of progressive clinical operations experience within the diagnostics, pharmaceutical, biotech, or CRO industry.
Proven experience planning, executing, and overseeing clinical trials from initiation to completion.
Expertise in CRO and vendor selection, budgeting, and management.
Experience managing central laboratory operations, including logistics, sample management, and data integrity.
Comprehensive understanding of clinical operations, including study design, protocol development, and data management.
Strong problem-solving skills to address challenges effectively during studies.
Excellent communication and interpersonal skills, with the ability to engage diverse audiences.
Active listening skills to understand and address team and stakeholder needs.
Demonstrated ability to work cross-functionally and deliver results in a fast-paced environment.
Experience fostering a culture of teamwork, adaptability, and innovative thinking.
Proficiency in inspection readiness activities and process development.
Motivated to contribute to infrastructure development in an early-stage start-up environment.
Willingness and ability to travel for site visits, study meetings, and conferences as required.
Preferred QualificationsExperience leading clinical trials in laboratory diagnostics or medical imaging.
Knowledge of clinical trial processes related to liver disease.
Expertise in central laboratory process development and management.
Experience with regulatory agency inspections and SOP development.
Prior experience in start-up environments.
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