Associate Clinical Operations Leader

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry.

About The Role

We are seeking an Associate Clinical Operations Leader to join our team in Bengaluru in a remote capacity. This position plays a key role in study execution, ICH-GCP and regulatory compliance, and clinical data quality. You will work under the guidance of an experienced Clinical Operations Leader, collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from start-up through close-out.

Key Responsibilities

• 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.

Requirements & Tech Stack

• Proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook) and WebEx.
• Ability to become proficient with Parexel systems.

Qualifications

• 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.

Preferred Qualifications

• 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.