Clinical Operations Specialist 26J25

The role of a Clinical Operations Specialist is pivotal in ensuring the efficient planning, execution, and management of clinical trials. Candidates taking up this position will play a crucial part in facilitating the operational aspects of clinical studies and trials to ensure they conform to regulatory standards and lead to successful outcomes. As a specialist in clinical operations, you will coordinate with multiple departments, interface with clinical partners, and oversee the logistical aspects of trials. You will contribute to the strategic planning and execution of operations that enhance clinical trial performance. This dynamic role requires an adept understanding of clinical trial methodologies and exceptional organizational skills. Successful candidates will possess the ability to lead projects, manage various tasks efficiently, and ensure all clinical activities align with broader objectives in drug development and patient care.

Responsibilities

• Coordinate and oversee daily operations of clinical trials to ensure efficient execution.
• Collaborate with cross-functional teams to align trials with company objectives.
• Manage clinical trial budgets and ensure financial oversight and compliance.
• Develop and implement operational strategies to enhance trial quality and reliability.
• Liaise with regulatory bodies to ensure all clinical operations are compliant with standards.
• Track and report clinical trial progress to stakeholders and suggest improvements.
• Supervise and train clinical operations staff to uphold high performance standards.
• Facilitate communication between trial sites and headquarters to streamline operations.
• Organize and oversee the proper documentation and archiving of clinical trial materials.
• Identify potential risks in clinical operations and proactively develop mitigation strategies.
• Maintain up-to-date knowledge of industry trends and regulatory changes affecting clinical trials.
• Ensure all trial activities align with ethical guidelines and patient safety standards.

Requirements

• Bachelor’s degree in Life Sciences, Nursing, or a related field required.
• Minimum of 3 years' experience in clinical operations or a similar environment.
• Strong knowledge of clinical trial processes, ICH-GCP, and regulatory requirements.
• Proven ability to manage clinical projects and budgets efficiently and effectively.
• Exceptional organizational and multitasking skills are essential for this role.
• Excellent verbal and written communication skills for effective liaison.
• Demonstrated leadership skills with the ability to train and mentor staff members.
• High attention to detail with a proactive approach to identifying issues.
• Proficient in using clinical trial management software and Microsoft Office Suite.