AD Clinical Operations at Judge Group

Location: Berkeley Heights, NJ
Salary: $165,000.00 USD Annually - $180,000.00 USD Annually
Description: Our client is currently seeking a AD Clinical Operations

Position Overview:

 

As the Associate Director of Clinical Operations, you will play a critical role in overseeing the operational aspects of clinical trials and ensuring the successful execution of clinical research activities. Your expertise in clinical operations will contribute to the efficient and effective implementation of clinical programs and the advancement of innovative therapies.

 

Responsibilities:

Clinical Trial Planning and Execution:

 

• Collaborate with cross-functional teams to develop and implement strategic plans for the execution of clinical trials.
• Oversee the operational aspects of clinical studies, including study start-up, enrollment, monitoring, and close-out activities.
• Ensure adherence to study protocols, regulatory guidelines, and Good Clinical Practice (GCP) standards.
• Monitor and manage clinical trial progress, timelines, and budgets to ensure successful completion.

Team Leadership and Management:

 

• Provide leadership and guidance to the clinical operations team, including Clinical Project Managers, Clinical Research Associates, and other relevant staff.
• Foster a collaborative and high-performance work environment, promoting professional growth and development.
• Manage resources effectively, including staffing, budget allocation, and vendor selection, to support clinical trial activities.

Compliance and Quality Assurance:

 

• Ensure compliance with relevant regulations, guidelines, and internal policies throughout the clinical trial process.
• Implement and maintain quality management systems to monitor and improve the quality of clinical operations.
• Conduct risk assessments and develop risk mitigation strategies to address potential issues or deviations.

Vendor and Stakeholder Management:

• Oversee relationships with external vendors, such as Contract Research Organizations (CROs), central laboratories, and other service providers.
• Collaborate with key stakeholders, including investigators, study sites, and regulatory authorities, to facilitate smooth study execution and timely communication.

Process Improvement and Innovation:

 

• Identify opportunities for process improvement, standardization, and innovation within clinical operations.
• Implement best practices, new technologies, and industry trends to enhance operational efficiency and data quality.
• Foster a culture of continuous improvement by promoting knowledge sharing and training initiatives.

 

Qualifications:

• Bachelor's degree in life sciences, pharmacy, nursing, or a related field. Advanced degree (e.g., Master's, Ph.D.) is preferred.
• Extensive experience (e.g., 8+ years) in clinical operations within the pharmaceutical, biotechnology, or medical device industry, including experience in a  managerial role.
• Experience with cardio metabolic diseases is highly preferred
• Strong knowledge of clinical trial processes, regulations (e.g., ICH-GCP), and industry best practices.
• Proven track record of successfully leading and managing clinical operations teams and multiple clinical trials simultaneously.
• Excellent organizational, communication, and leadership skills.
• Ability to collaborate effectively with cross-functional teams and external stakeholders.
• Strong problem-solving and decision-making abilities in a fast-paced and dynamic environment.
• Proficiency in using clinical trial management systems (CTMS) and other relevant software.

Contact: arawat@judge.com