Associate Clinical Operations Leader

🔥 1 minute ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Coordinate and direct clinical project team members on small to midsize studies • Provide productivity targets, performance feedback, and input to study-specific training • Manage study start-up activities, including project plans, site selection strategy, monitoring plans, and patient recruitment and retention plans • Monitor study timelines, patient recruitment, patient retention, and data cleaning • Address escalated site issues, identify potential problems early, and support contingency planning • Communicate with internal and external customers, sponsors, investigational sites, and third-party vendors • Evaluate resourcing needs and monitor resource use across the project life cycle • Prepare for and participate in audits and inspections • Support maintenance and quality checks of central files • Ensure compliance with ICH-GCP, local regulatory requirements, Parexel SOPs, work instructions, and operational guidelines • Collaborate on database lock, project close-out, and archiving activities • Support process improvement initiatives and contribute lessons learned at study close-out

🎯 Requirements

• 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 • Ability to manage multiple tasks and prioritize workload with attention to detail • Proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook) and WebEx • Ability to become proficient with Parexel systems • 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

🏖️ Benefits

• Flexible work arrangements • Growth opportunities • Continuous learning opportunities • Career path exploration and skill expansion • Diverse teams • Ability to travel as required