Associate Clinical Operations Leader

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee and guide clinical project team members on small to midsize studies.

• Set productivity benchmarks, provide performance feedback, and contribute to study-specific training.

• Manage activities related to study start-up, including project planning, site selection strategies, monitoring plans, and strategies for patient recruitment and retention.

• Track study timelines, patient recruitment, patient retention, and data integrity.

• Address advanced site issues, proactively identify potential challenges, and assist in contingency planning.

• Liaise with internal and external stakeholders, including customers, sponsors, investigational sites, and third-party vendors.

• Assess resource requirements and oversee resource utilization throughout the project life cycle.

• Prepare for and engage in audits and inspections.

• Assist in maintaining and performing quality checks on central files.

• Ensure adherence to ICH-GCP, local regulatory standards, Parexel SOPs, work instructions, and operational guidelines.

• Collaborate on database locking, project closure, and archiving processes.

• Support initiatives for process improvement and contribute insights at project close-out.

⛳️ Requirements

• Bachelor's degree in a life science field or a nursing qualification, or equivalent clinical or clinical management experience.

• Significant relevant experience in clinical research operations, including Clinical Research Associate (CRA) experience or a comparable role.

• Understanding of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP), regulatory requirements, and clinical trial methodologies throughout the entire project life cycle.

• Excellent written and verbal communication skills in English, with proficiency in local languages as necessary.

• Strong organizational, communication, and problem-solving abilities.

• Capacity to handle multiple tasks and prioritize responsibilities while maintaining attention to detail.

• Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook) and WebEx.

• Capability to quickly learn and become proficient with Parexel systems.

• Experience in coordination, ideally acquired in a Senior CRA or Senior CMA role.

• Experience in on-site monitoring.

• Proficiency in local languages for assigned regions.

• Willingness to travel as necessary.

🏝️ Benefits

• Flexible work arrangements.

• Opportunities for growth.

• Continuous learning opportunities.

• Pathways for career exploration and skill enhancement.

• Diverse teams.

• Ability to travel as needed.