Manager, Clinical Operations

Overview

Manage a clinical operations team and support study execution, regulatory compliance and on-time, high-quality project delivery on client clinical research projects.

What you'll do

• Monitor project and team performance through close interaction with project and functional leadership, keeping project documentation and correspondence accurate and complete.
• Serve as an ongoing liaison with project teams, sponsors and management on the performance of direct reports.
• Manage and oversee team activities, including resourcing, staff assignments, quality control and the efficiency of project deliverables.
• Produce accurate resourcing plans with appropriate project team members, and monitor resource needs throughout the project.
• Develop action plans with management and project leadership to keep projects on time and within budget, and facilitate metrics collection.
• Recruit, retain and develop a skilled, experienced and motivated team through training, mentoring and allocation of staff according to their ability.
• Conduct quality checks of deliverables and take appropriate remedial action to meet departmental and project productivity and quality metrics.
• Provide technical support and clinical consultation to project teams, ensuring staff have the knowledge required to fulfill their duties.
• Support staff in improving efficiency and effectiveness at prioritizing work, and participate in formal staff review processes, including performance and salary reviews.
• Serve as a senior-level contributor on project teams, ensuring high-quality and timely delivery of your own deliverables and generating study-specific status reports for study teams, sponsors and management.
• Maintain working knowledge of, and ensure compliance with, ICH Guidelines, Good Clinical Practice, regulatory agency requirements, and Parexel and sponsor SOPs.
• Where appropriate, contribute to project bids, client presentations and business lead generation.

What you'll need

• Educated to degree level, or an equivalent nursing qualification or relevant clinical or other equivalent experience.
• Substantial monitoring or data management experience, or equivalent experience in clinical research, with a strong understanding of the clinical trials environment.
• Knowledge of ICH-GCP, regulatory requirements and clinical trial processes.
• Experience with study documentation and quality control processes, including Central File documentation.
• Competency in the local language and written English.
• Strong communication, organization and problem-solving skills.

Nice to have

• Degree in a biological science, pharmacy or other health-related discipline.
• Oral English competency.

Details

• Location: Bengaluru, India.
• Work mode: onsite.
• Works under the supervision of a Senior Manager, Associate Director or Director.