Associate Clinical Operations Leader

Overview

Associate Clinical Operations Leader supporting clinical research activities, study execution, ICH-GCP and regulatory compliance, and clinical data quality, working under an experienced Clinical Operations Leader in a remote capacity from Bengaluru.

What you'll do

• Take on Clinical Operations Leader responsibilities for assigned countries or selected tasks
• Coordinate and direct clinical project team members on small to midsize studies, providing productivity targets, performance feedback, and input to study-specific training
• Manage study start-up activities, including input to project plans, site selection strategy, monitoring plans, and patient recruitment and retention plans
• Monitor study timelines, patient recruitment, patient retention, and data cleaning to support a successful project outcome
• Address escalated site issues and drive them to closure, identifying potential problems early and supporting contingency planning
• Communicate effectively with internal and external customers, sponsors, investigational sites, and third-party vendors, prioritizing urgent requests
• Evaluate resourcing needs and monitor the use of resources across the project life cycle
• Prepare for and participate in audits and inspections, and support the maintenance and quality checks of central files
• Ensure compliance with ICH-GCP, local regulatory requirements, and Parexel SOPs, work instructions, and operational guidelines
• Collaborate on database lock, project close-out, and archiving activities with Project Leaders and Data Operations Leaders
• Support process improvement initiatives and contribute lessons learned at study close-out
• Coach and serve as a role model for your team, and manage site and study issues
• May be part of a global project management team

What you'll need

• Degree in a life science or a nursing qualification, or relevant clinical or clinical management experience
• Substantial relevant work experience in clinical research operations, such as Clinical Research Associate (CRA) experience or equivalent
• Knowledge of International Council for Harmonisation (ICH) Good Clinical Practice (GCP), regulatory requirements, and clinical trial processes across the full project life cycle
• Strong command of written and spoken English, with local language proficiency as required
• Strong communication, organization, and problem-solving skills, with the ability to manage multiple tasks and prioritize workload with attention to detail
• Strengths in leading virtual teams across locations and cultures, negotiating and influencing with diplomacy, and root cause analysis
• Substantial experience in clinical research, with an understanding of cross-functional activities in data processing, data cleaning, and site management
• Ability to collaborate across teams, build trust with clients and colleagues, and communicate clearly in writing and in person
• Commitment to high-quality work, strong attention to detail, and a sense of urgency
• Proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook) and WebEx, and the ability to become proficient with Parexel systems

Nice to have

• Coordinating experience, preferably gained in a Senior CRA or Senior CMA position
• On-site monitoring experience
• Local language proficiency for assigned countries
• Ability to travel as required

Details

• Location: Bengaluru, India
• Work mode: Remote