Clinical Operations Specialist (225-929)

The Clinical Operations Specialist plays a critical role in managing and optimizing the operations within clinical settings, ensuring that all processes are efficient, compliant, and focused on patient safety and quality care. This position involves coordinating and supervising clinical trials, managing project timelines, and working closely with various stakeholders, including medical professionals, regulatory bodies, and internal teams. The Clinical Operations Specialist must possess a strong understanding of clinical trial management, industry regulations, and have a keen eye for detail. This role requires excellent organizational skills, the ability to multitask, and effective communication skills to coordinate efforts across multiple departments and ensure the smooth operation of clinical projects. A successful Clinical Operations Specialist is proactive, analytical, and committed to maintaining high standards of clinical excellence and operational integrity.

Responsibilities

• Coordinate and oversee daily operations of clinical trials to ensure efficiency and quality.
• Develop and implement operational strategies that align with organizational goals and compliance standards.
• Monitor project timelines and budgets to ensure adherence to planned schedules and cost constraints.
• Establish and maintain effective communication channels between clinical staff, stakeholders, and regulatory bodies.
• Ensure that all clinical operations are conducted in accordance with ethical guidelines and industry regulations.
• Collaborate with research teams to plan, conduct, and evaluate clinical trials and studies.
• Identify and resolve operational issues, optimizing processes for improved clinical outcomes.
• Prepare and present reports on clinical operations performance and progress to senior management.
• Train and support staff on clinical procedures, compliance requirements, and operational protocols.
• Assist in the development and implementation of quality assurance and risk management plans.
• Maintain comprehensive documentation of clinical trial activities, ensuring accuracy and completeness.
• Facilitate audits and inspections, ensuring readiness and adherence to regulatory requirements.

Requirements

• Bachelor's degree in life sciences, healthcare management, or a related field.
• Minimum of 3 years of experience in clinical operations or clinical trial management.
• Strong knowledge of clinical research processes and regulatory requirements.
• Excellent organizational and time-management skills with attention to detail.
• Demonstrated ability to manage multiple projects and priorities effectively.
• Strong analytical and problem-solving skills to address operational challenges.
• Effective communication and interpersonal skills to collaborate across different teams.