Manager, Clinical Operations - FSP

📋 Description

• • Oversee project delivery and performance by closely collaborating with project and functional leadership to ensure accurate, complete documentation and correspondence across clinical trials.
• • Serve as a senior-level contributor on project teams, delivering high-quality, timely outputs including study-specific status reports for sponsors, management, and internal teams.
• • Manage and optimize team resourcing by identifying, assigning, and monitoring staff needs throughout the project lifecycle in alignment with project timelines and budgets.
• • Lead and supervise direct reports, ensuring efficient execution of project deliverables through quality control measures such as on-site visits and central file reviews.
• • Implement action plans with management and project leads to maintain project timelines and budgets, using metrics and performance data to drive improvements.
• • Provide technical guidance and support to staff to ensure competency in clinical trial processes, regulatory standards, and internal SOPs.
• • Conduct performance evaluations and participate in formal review processes aligned with corporate standards, including salary and performance assessments.
• • Recruit, retain, and develop a skilled, motivated clinical operations team that consistently exceeds client expectations and business objectives.
• • Drive staff development through mentoring, training, and workload allocation based on individual capabilities and performance metrics.
• • Monitor and improve team efficiency by analyzing work output, client feedback, audit results, and quality control indicators to identify areas for improvement.
• • Champion and implement system and process improvement initiatives within Parexel and departmental frameworks.
• • Maintain required levels of productivity, billability, and staff retention while ensuring compliance with ICH-GCP, regulatory requirements, and Parexel SOPs.
• • Complete administrative tasks promptly, including timesheets, training records, and travel expense claims, and travel as required for project or operational needs.
• • Foster a positive, results-driven work environment by modeling teamwork, open communication, and objective leadership.
• • Act as a local leader and role model, potentially serving as GMBA for a country or region, and represent the function in management meetings.
• • Ensure adherence to corporate policies and escalate issues to management as needed, demonstrating leadership across departmental, functional, or geographic teams.
• • Maintain working knowledge of clinical trial environments, including monitoring and data management practices, and apply this expertise to operational decision-making.