Senior Manager Clinical Operations

Clinical Operations Leadership & Team Management
Lead, coach, mentor, and develop a high-performing Clinical Operations team.
Manage employee selection, performance management, compensation processes, and career development activities.
Set clear objectives, KPIs, and expectations while providing regular feedback and recognition.
Foster an engaging, collaborative, and motivating work environment that supports employee development and retention.
Ensure operational excellence through effective team leadership and resource management.
Direct the strategic planning and execution of clinical studies to generate robust evidence supporting product development and commercial success.
Ensure studies are conducted in accordance with regulatory requirements, company procedures, budgets, timelines, and quality standards.
Allocate resources effectively to support study execution and optimize project delivery.
Oversee study progress and proactively address risks, challenges, and operational bottlenecks.
Ensure adherence to global clinical processes and procedures through training, development, and continuous improvement initiatives.
Regulatory Compliance & Quality Oversight
Act as a subject matter expert on ICH-GCP, ISO, FDA, and other applicable regulatory requirements related to clinical research involving human subjects.
Ensure compliance with global clinical research legislation and regulatory expectations.
Oversee audit requests, responses, effectiveness checks, and corrective actions.
Share best practices and regulatory expertise related to clinical evaluations, clinical trials, safety assessments, product development, and post-market activities.
Drive continuous improvement initiatives to strengthen compliance and operational effectiveness.
Lead cross-functional collaborations with Clinical, Medical, Regulatory Affairs, R&D, Quality, HEMAR, Biostatistics, Data Management, Clinical Development, and other internal stakeholders.
Manage supplier and vendor relationships to ensure successful study execution and operational performance.
Provide strategic guidance and insights to senior leadership and executive stakeholders.
Support organizational objectives by aligning clinical research activities with broader business strategies.
Identify opportunities to improve clinical development processes, drive innovation, and enhance organizational capabilities.