Associate Director of Clinical Operations
EPM Scientific - San Diego, CA
Apply NowJob Description
Associate Director of Clinical OperationsSan Diego, CA - Hybrid$150,000 - $1800,000A clinical-stage biotechnology company in San Diego is dedicated to developing transformative medicines for patients with life-threatening diseases. This company focuses on precision medicine, leveraging advanced technologies to create innovative therapies that address significant unmet medical needs. With a robust pipeline targeting various cancer types and other serious conditions, the company is at the forefront of developing next-generation treatments. Supported by a strong leadership team with extensive industry experience and significant funding from top-tier investors, the company is well-positioned for rapid growth and success in the biotech industry. Joining this team means being part of a passionate group committed to making a tangible difference in patients' lives.Responsibilities:Oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory requirements and company standardsManage relationships with CROs and other vendors, including contract negotiations and performance monitoringProvide direction and support to clinical operations team members, fostering a collaborative and high-performance environmentEnsure all clinical activities adhere to GCP, FDA, and other regulatory guidelinesDevelop and manage clinical trial budgets, ensuring cost-effective use of resourcesIdentify potential risks and implement mitigation strategies to ensure the successful completion of clinical trialsEnsure the accuracy and integrity of clinical trial data through rigorous monitoring and quality control processesWork closely with other departments, including clinical development, regulatory affairs, and data management, to achieve project goalsOversee the preparation and review of clinical trial documentation, including protocols, informed consent forms, and study reportsIdentify opportunities for process improvements and implement best practices in clinical operationsQualificationsBachelor's degree in a scientific or health-related field.At least 2 years of experience in clinical research, ideally within a biopharmaceutical or CRO setting.Knowledge of FDA regulations and ICH/GCP guidelines is essential.Strong organizational and multitasking skills, with the ability to work in a collaborative team environment.Excellent written and verbal communication skills.Problem-solving and negotiation abilities, with the ability to adapt as needed.Proficiency in Microsoft Office and experience with clinical trial management systems (e.g., Medidata Rave, InForm).This role offers the opportunity to contribute to groundbreaking therapies in a dynamic and innovative environment. If you are passionate about clinical operations and making a difference in patients' lives, we encourage you to apply.
Created: 2025-01-30